mHealth for Self-care of Heart Failure in Uganda

• Sponsor: Yale University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04426630
• Collaborator: Fogarty International Center of the National Institute of Health (NIH), Makerere University (Other), Uganda Heart Institute (Other), University Health Network, Toronto (Other)
• Enrollment: 72
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24.9
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

Heart failure affects more than 38 million people globally. It is responsible for high rates of hospitalization and premature mortality, especially in sub-Saharan Africa. Heart failure causes multiple debilitating and distressing symptoms. These symptoms can often be managed by patients themselves but only when they are able to identify symptoms and select appropriate actions. Self-care, a World Health Organization-endorsed intervention for chronic conditions like heart failure, is greatly underutilized in lower and middle income countries, including Uganda. Self-care refers to the ability of patients, caregivers and communities to maintain health, prevent disease, and manage illness, with or without a healthcare provider. Mobile health (mHealth) offers a promising platform to address this need gap in lower and middle income countries. mHealth takes advantage of the widespread usage of mobile phones to offer patients individualized self-care tools such as education, healthy lifestyle prompts, and support with making decisions. Since 2016, this multidisciplinary, international research team has been designing Medly Uganda, an mHealth application to improve self-care among Ugandan patients with heart failure. This application began as a smartphone but was adapted for the low-cost feature phones used widely throughout the country. It was also integrated into an mHealth system endorsed by the Ugandan Ministry of Health. When patients log in they are prompted to report on specific heart failure symptoms. The application then generates self-care instructions based on those symptoms. If a patient reports serious symptoms the application triggers an alert to the research nurse, who then consults with the patient, caregiver, and if needed, cardiologist, to establish a plan of care. This study proposes that an mHealth intervention tailored specifically to the local context will improve healthcare quality of life for patients with heart failure. The research team hypothesizes that heart failure patients who use the program will report improved scores on the Self-Care in Heart Failure Index. These scores will be assessed at baseline, three-month, and six-month visits. The researchers will also measure changes in patients' clinical conditions, including the 6-minute walk test, left ventricular ejection fraction, and frequency of acute care visits. Finally, the researchers will conduct qualitative interviews with patients and providers to understand their experiences.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: mHealth for heart failure patients in Uganda	N/A

Detailed Description

Participants will be asked to initiate self-care sessions using the Medly Uganda application. They will dial the sub-code and enter a unique PIN to access the system. They are asked to do this every Monday, Wednesday, and Friday morning for six months, as well as anytime that they experience concerning symptoms. If a participant has not initiated a session by 11:00am on the designated days, the application will generate an SMS reminder. Each interactive session will present a series of symptom-based questions to the participant. These questions will be followed by a tailored SMS message. While session content will not remain on the participant's phone, the SMS messages will. This allows participants to retain and review messages, thereby reinforcing educational content. There are four status categories: Stable, Fluid Overload, Urgent, and Critical. If Stable, participants will be sent one of six encouraging and educational messages. If Fluid Overload, Urgent or Critical, patient participants will be sent a message that identifies the symptom and recommends an action and the on-duty nurse will be sent an accompanying alert. Urgent and Critical alerts will also be sent to the on-duty doctor. The nurse is expected to call the patient for Urgent and Critical alerts within 60 and 15 minutes, respectively. Nurse phone call interactions will be guided by a standard operating manual. One nurse and one doctor will be designated rotating 'on-duty' responsibility to monitor clinician alerts and the dashboard seven days a week. The doctor will be available to provide clinical supervision to the nurse as needed and they will have a daily in-person or by-phone.

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This is a single-center prospective cohort study. The researchers will use consecutive sampling to identify potential patient participants.This is a single-center prospective cohort study. The researchers will use consecutive sampling to identify potential patient participants.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Accessible, Scalable, Patient-facing mHealth Application for Self-care of Heart Failure in LMIC
• Actual Study Start Date: Oct 19, 2020
• Actual Primary Completion Date: Sep 6, 2021
• Anticipated Study Completion Date: Nov 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: mHealth Heart failure patients enrolled in the mHealth program	Other: mHealth for heart failure patients in Uganda; Patients at Uganda Heart Institute will be enrolled in an mHealth program intended to promote self-care for heart failure and improve their healthcare quality of life.

Outcome Measures

Primary Outcome Measures

1. Self-Care for Heart Failure Index, Maintenance [Baseline and Six-month follow-up]

   The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care maintenance subscale includes 10 items asking how often patients check their heart failure symptoms and treatment adherence. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-maintenance.

2. Self-Care for Heart Failure Index, Management [Baseline and Six-month follow-up]

   The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care management subscale includes 6 items if patients report any heart failure symptoms in the past month. Then based on the responses on how quick they recognize it as a symptom of heart failure and remedies they tried, the score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-management.

3. Self-Care for Heart Failure Index, Confidence [Baseline and Six-month follow-up]

   The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care confidence subscale includes 6 items asking how confident that they can keep themselves free of symptoms, follow treatment advice, recognize changes in their health and etc.. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-confidence

Secondary Outcome Measures

1. EQ-5D-5L, Mobility [Baseline and Six-month follow-up visit]

   Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).

2. EQ-5D-5L, Self-Care [Baseline and Six-month follow-up visit]

   Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).

3. EQ-5D-5L, Usual Activities [Baseline and Six-month follow-up visit]

   Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).

4. EQ-5D-5L, Pain or Discomfort [Baseline and Six-month follow-up visit]

   Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).

5. EQ-5D-5L, Anxiety or Depression [Baseline and Six-month follow-up visit]

   Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).

6. EQ-5D-5L, VAS [Baseline and Six-month follow-up visit]

   The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the 100 indicates 'The best health you can imagine' and 0 means 'The worst health you can imagine'.

7. Six-Minute Walk Test, Total Distance [Baseline and Six-month follow-up visit]

   Patients' functional capacity will be assessed using the Six-Minute Walk Test, a widely-used, reproducible exercise test that serves as a strong predictor of morbidity and mortality in heart failure patients. Outcome is measured as a distance in meters. Possible range is 0-700m. Healthy range is considered 400-700m but may not be normative for all populations, including people with chronic diseases. In this study difference in distance (meters) will be examined across visits, with a lower score reflecting worse function.

8. Left Ventricular Ejection Fraction [Baseline and Six-month follow-up visit]

   Left ventricular ejection fraction (LVEF) is a widely-recognized clinical prognostic marker for heart failure patients. It is measured as a percentage. Possible range is 0-100. Low is <50%. High is >=50%. LVEF is measured by echocardiogram using Simpson biplane formula

9. Frequency of Acute Care Visits [Baseline and Six-month follow-up visit]

   Patients will be asked to report how often they required acute care for their heart failure outside of their usual care. This outcome is the frequency of acute care visits as categorical variable: 0, 1 and ≥2. Possible range is 0-31.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• UHI patient presenting for routine or urgent outpatient visit

• Currently living in Uganda and not planning to travel abroad for six months

• Age >=18 years

• Symptomatic heart failure (New York Heart Association Class II or III and left ventricular ejection fraction of 45% or less)

• Access to a mobile phone

• Basic reading skills in English, Luganda, and/or Runyankole

Exclusion Criteria:

• Life expectancy < six months

• Active medical condition requiring hospitalization, such as cardiac ischemia (acute electrocardiographic changes and/or positive biomarkers, if available), syncope, or significant fluid overload

• Pregnancy

• Inability to provide informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uganda Heart Institute	Kampala		Uganda

Sponsors and Collaborators

• Yale University
• Fogarty International Center of the National Institute of Health
• Makerere University
• Uganda Heart Institute
• University Health Network, Toronto

Investigators

• Principal Investigator: Jeremy Schwartz, MD, Yale University
• Principal Investigator: Isaac Ssinabulya, MMed, Uganda Heart Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 15, 2019
• Informed Consent Form - Apr 15, 2019

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT04426630
• Other Study ID Numbers: 2000025338; 1R21TW010998-01A1
• First Posted: Jun 11, 2020
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yale University: Heart Failure; Telemedicine; Uganda; mHealth; Implementation Science
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
Period Title: Overall Study
STARTED	72
COMPLETED	66
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients enrolled in the mHealth program mHealth for heart failure patients in Uganda: Patients at Uganda Heart Institute will be enrolled in an mHealth program intended to promote self-care for heart failure and improve their healthcare quality of life.
Overall Participants	72
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	70 97.2%
>=65 years	2 2.8%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	53.0
Sex: Female, Male (Count of Participants)
Female	33 45.8%
Male	39 54.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	72 100%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Uganda	72 100%
Healthcare Quality of Life: EQ-5D (Count of Participants)
No Problem	47 65.3%
Having Problems	25 34.7%
No Problem	42 58.3%
Having Problems	30 41.7%
No Problem	33 45.8%
Having Problems	39 54.2%
No Problem	42 58.3%
Having Problems	30 41.7%
No Problem	44 61.1%
Having Problems	28 38.9%
Health Quality of Life: EQ VAS (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	70

Outcome Measures

1. Primary Outcome

Title	Self-Care for Heart Failure Index, Maintenance
Description	The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care maintenance subscale includes 10 items asking how often patients check their heart failure symptoms and treatment adherence. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-maintenance.
Time Frame	Baseline and Six-month follow-up

Outcome Measure Data

Analysis Population Description

6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
Measure Participants	72
Baseline	35
Six-month	85

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mHealth
	Comments	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments	Wilcoxon signed rank test

2. Primary Outcome

Title	Self-Care for Heart Failure Index, Management
Description	The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care management subscale includes 6 items if patients report any heart failure symptoms in the past month. Then based on the responses on how quick they recognize it as a symptom of heart failure and remedies they tried, the score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-management.
Time Frame	Baseline and Six-month follow-up

Outcome Measure Data

Analysis Population Description

The management sub-scale only score if the patient acknowledged having trouble breathing or ankle swelling in the past interval.

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
Measure Participants	72
Baseline	20
Six-month	85

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mHealth
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments	Wilcoxon signed rank test

3. Primary Outcome

Title	Self-Care for Heart Failure Index, Confidence
Description	The Self-care of Heart Failure Index (SCHFI) is a measure of self-care defined as a naturalistic decision-making process involving the choice of behaviors that maintain physiological stability (maintenance), the response to symptoms when they occur (management), and confidence in self-care (confidence). The self-care confidence subscale includes 6 items asking how confident that they can keep themselves free of symptoms, follow treatment advice, recognize changes in their health and etc.. The score is standardized to a 0- to 100-point range: raw score sum minus lowest possible raw scale score, then divided by the possible range of scores, and finally multiplied by 100. Higher score for each scale indicates better self-confidence
Time Frame	Baseline and Six-month follow-up

Outcome Measure Data

Analysis Population Description

6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
Measure Participants	72
Baseline	41.2
Six-month	97.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mHealth
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments	Wilcoxon signed rank test

4. Secondary Outcome

Title	EQ-5D-5L, Mobility
Description	Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).
Time Frame	Baseline and Six-month follow-up visit

Outcome Measure Data

Analysis Population Description

6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
Measure Participants	72
No Problems	47 65.3%
Having Problems	25 34.7%
No Problems	54 75%
Having Problems	12 16.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mHealth
	Comments	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.028
	Comments
	Method	Chi-squared
	Comments	Wilcoxon sign-rank test used to compared baseline outcomes to 6 month outcomes.

5. Secondary Outcome

Title	EQ-5D-5L, Self-Care
Description	Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).
Time Frame	Baseline and Six-month follow-up visit

Outcome Measure Data

Analysis Population Description

6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
Measure Participants	72
No problems	42 58.3%
Having problems	30 41.7%
No problems	58 80.6%
Having problems	8 11.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mHealth
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

6. Secondary Outcome

Title	EQ-5D-5L, Usual Activities
Description	Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).
Time Frame	Baseline and Six-month follow-up visit

Outcome Measure Data

Analysis Population Description

6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
Measure Participants	72
No problems	33 45.8%
Having problems	39 54.2%
No problems	54 75%
Having problems	12 16.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mHealth
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

7. Secondary Outcome

Title	EQ-5D-5L, Pain or Discomfort
Description	Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).
Time Frame	Baseline and Six-month follow-up visit

Outcome Measure Data

Analysis Population Description

6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
Measure Participants	72
No problems	42 58.3%
Having problems	30 41.7%
No problems	45 62.5%
Having problems	21 29.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mHealth
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.23
	Comments
	Method	Chi-squared
	Comments

8. Secondary Outcome

Title	EQ-5D-5L, Anxiety or Depression
Description	Measure Description: Healthcare quality of life will be measured using the 5-level EQ-5D version (EQ-5D-5L). It is a validated instrument appropriate for use in lower and middle income countries. Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) comprises the EQ-5D descriptive system. We regrouped the 5 levels of perceived problems into binary responses as "no problem" (Level 1), or "Having problems" (Level 2-5).
Time Frame	Baseline and Six-month follow-up visit

Outcome Measure Data

Analysis Population Description

6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
Measure Participants	72
No problems	44 61.1%
Having problems	28 38.9%
No problems	57 79.2%
Having problems	9 12.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mHealth
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

9. Secondary Outcome

Title	EQ-5D-5L, VAS
Description	The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the 100 indicates 'The best health you can imagine' and 0 means 'The worst health you can imagine'.
Time Frame	Baseline and Six-month follow-up visit

Outcome Measure Data

Analysis Population Description

6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
Measure Participants	72
Baseline	70
Six-month	80

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mHealth
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments	Wilcoxon signed rank test

10. Secondary Outcome

Title	Six-Minute Walk Test, Total Distance
Description	Patients' functional capacity will be assessed using the Six-Minute Walk Test, a widely-used, reproducible exercise test that serves as a strong predictor of morbidity and mortality in heart failure patients. Outcome is measured as a distance in meters. Possible range is 0-700m. Healthy range is considered 400-700m but may not be normative for all populations, including people with chronic diseases. In this study difference in distance (meters) will be examined across visits, with a lower score reflecting worse function.
Time Frame	Baseline and Six-month follow-up visit

Outcome Measure Data

Analysis Population Description

6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
Measure Participants	72
Baseline	320.3
Six-month	340.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mHealth
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments	Wilcoxon signed rank test

11. Secondary Outcome

Title	Left Ventricular Ejection Fraction
Description	Left ventricular ejection fraction (LVEF) is a widely-recognized clinical prognostic marker for heart failure patients. It is measured as a percentage. Possible range is 0-100. Low is <50%. High is >=50%. LVEF is measured by echocardiogram using Simpson biplane formula
Time Frame	Baseline and Six-month follow-up visit

Outcome Measure Data

Analysis Population Description

6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
Measure Participants	72
Baseline	30
Six-month	33.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mHealth
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments	Wilcoxon signed rank test

12. Secondary Outcome

Title	Frequency of Acute Care Visits
Description	Patients will be asked to report how often they required acute care for their heart failure outside of their usual care. This outcome is the frequency of acute care visits as categorical variable: 0, 1 and ≥2. Possible range is 0-31.
Time Frame	Baseline and Six-month follow-up visit

Outcome Measure Data

Analysis Population Description

6 participants did not complete six months assessment: 4 participants deceased during the study period and 2 participants lost follow-up.

Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
Measure Participants	72
0	56 77.8%
1	12 16.7%
≥2	4 5.6%
0	60 83.3%
1	6 8.3%
≥2	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	mHealth
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	mHealth
Arm/Group Description	Heart failure patients in Uganda were enrolled in an mHealth program at the Uganda Heart Institute. The program intended to promote self-care for heart failure and improve patient healthcare quality of life.
All Cause Mortality
	mHealth
	Affected / at Risk (%)	# Events
Total	4/72 (5.6%)
Serious Adverse Events
	mHealth
	Affected / at Risk (%)	# Events
Total	0/72 (0%)
Other (Not Including Serious) Adverse Events
	mHealth
	Affected / at Risk (%)	# Events
Total	0/72 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.