Feasibility of a Mobile Application to Support Reflection and Dialog About Strengths in People With Chronic Illness

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03437863
• Collaborator: South-Eastern Norway Regional Health Authority (Other), Diakonhjemmet Hospital (Other)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.1
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

Self-management of chronic illness can be highly demanding and people need to mobilize their personal strengths in order to live well with their condition. A mobile application was designed in collaboration with people with chronic illness and health care providers with the aims to support awareness of patients' strengths and patient-provider dialogues that include strengths. The aim of the present study is to evaluate with mixed methods the perceived usefulness and usability of the application and potential effects of the application on patients.

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease; Rheumatic Diseases	Device: Mobile application	N/A

Detailed Description

In this pre-post design pilot study participants will be recruited from self-management courses for people with rheumatic diseases. Before using the application participants will be asked to report their strengths in a written format. After using the mobile application to reflect on their strengths the participants will be interviewed about their experience of using the application and on the task of reflecting on their strengths. They will also be asked to fill out a questionnaire on perceived usefulness and user-friendliness. Before and after using the application the participants fill out questionnaires on emotions (Positive and Negative Affective Scale) and self-efficacy (The Arthritis Self-efficacy Scale). All interviews will be audio-taped and analyzed with a qualitative approach. Descriptive analysis will be applied for quantitative data.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Participants will be recruited to a pre-post design study.Participants will be recruited to a pre-post design study.
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Capitalizing on the Strengths of Persons With Rheumatoid Arthritis to Improve Health and Wellness
• Actual Study Start Date: Apr 18, 2018
• Actual Primary Completion Date: Sep 20, 2018
• Actual Study Completion Date: Sep 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mobile application Participants recruited from a self-management course are asked to use (single time) a mobile application to support reflection of personal strengths. The participant borrows an Ipad and uses the application to 1) reflect and identify their strengths by reviewing a list of examples, 2) define personal goals, and 3) link strengths to goals.	Device: Mobile application; Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals.

Outcome Measures

Primary Outcome Measures

1. Perceived Usefulness of the Application [Within an hour after using the application]

   Study-specific questions on perceived usefulness of the application

2. The System Usability Scale [Within an hour after using the application]

   This 10 item questionnaire measures usability. Each item has 5 response options with total score ranging from 0 to 100. Higher values represent a better outcome.

Secondary Outcome Measures

1. The Positive and Negative Affect Schedule. [Pre-intervention and post-intervention, within an hour after using the application]

   This scale measures positive and negative affect with two subscales (positive affect and negative affect). Positive affect subscale scores can range from 10-50, with higher scores representing higher levels of positive affect. Negative affect subscale scores can range from 10-50, with lower scores representing lower levels of negative affect.

2. The Arthritis Self-efficacy Scale [Pre-intervention and post-intervention, within an hour after using the application]

   This scale measures self-efficacy with two subscales with 5 response options. The "pain" subscale has 5 items and a score range from 0 to 20. The "other symptoms" subscale has 6 items and a score range from 0 to 24. Higher scores equal higher levels of self-efficacy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Setting 1:

Inclusion Criteria:

• Age of 18 years or older

• Can read and speak Norwegian language

• Diagnosed with a chronic condition

• Participating or having recently participated in a learning and mastery or an outpatient rehabilitation program

No exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diakonhjemmet Hospital	Oslo		Norway	0370

Sponsors and Collaborators

• Oslo University Hospital
• South-Eastern Norway Regional Health Authority
• Diakonhjemmet Hospital

Investigators

• Principal Investigator: Olöf B Kristjansdottir, PhD, Oslo University Hospital, Center for Shared Decision Making and Collaborative Care Research

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 19, 2021

More Information

Publications

None provided.

• Responsible Party: Elin Borosund, Principal Investigator, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT03437863
• Other Study ID Numbers: 2015065
• First Posted: Feb 19, 2018
• Last Update Posted: Nov 16, 2021
• Last Verified: Nov 1, 2021

• 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 Elin Borosund, Principal Investigator, Oslo University Hospital: self-management; health assets; Strengths; mHealth; Feasibility
• Additional relevant MeSH terms: Rheumatic Diseases; Collagen Diseases; Chronic Disease

Study Results

Participant Flow

Arm/Group Title	Mobile Application
Arm/Group Description	Participants recruited from a self-management course are asked to use (single time) a mobile application to support reflection of personal strengths. The participant borrows an Ipad and uses the application to 1) reflect and identify their strengths by reviewing a list of examples, 2) define personal goals, and 3) link strengths to goals. Mobile application: Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals.
Period Title: Overall Study
STARTED	12
COMPLETED	12
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Mobile Application
Arm/Group Description	Participants recruited from a self-management course are asked to use (single time) a mobile application to support reflection of personal strengths. The participant borrows an Ipad and uses the application to 1) reflect and identify their strengths by reviewing a list of examples, 2) define personal goals, and 3) link strengths to goals. Mobile application: Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals.
Overall Participants	12
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	50.0
Sex: Female, Male (Count of Participants)
Female	11 91.7%
Male	1 8.3%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Perceived Usefulness of the Application
Description	Study-specific questions on perceived usefulness of the application
Time Frame	Within an hour after using the application

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mobile Application
Arm/Group Description	Participants recruited from a self-management course are asked to use (single time) a mobile application to support reflection of personal strengths. The participant borrows an Ipad and uses the application to 1) reflect and identify their strengths by reviewing a list of examples, 2) define personal goals, and 3) link strengths to goals. Mobile application: Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals.
Measure Participants	12
Agree or strongly agree	12 100%
Disagree or strongly disagree	0 0%
Neutral	0 0%
Mssing	0 0%
Agree or strongly agree	9 75%
Disagree or strongly disagree	1 8.3%
Neutral	2 16.7%
Mssing	0 0%
Agree or strongly agree	10 83.3%
Disagree or strongly disagree	0 0%
Neutral	2 16.7%
Mssing	0 0%
Agree or strongly agree	5 41.7%
Disagree or strongly disagree	2 16.7%
Neutral	4 33.3%
Mssing	1 8.3%
Agree or strongly agree	6 50%
Disagree or strongly disagree	0 0%
Neutral	5 41.7%
Mssing	1 8.3%
Agree or strongly agree	7 58.3%
Disagree or strongly disagree	0 0%
Neutral	4 33.3%
Mssing	1 8.3%
Agree or strongly agree	8 66.7%
Disagree or strongly disagree	0 0%
Neutral	4 33.3%
Mssing	0 0%
Agree or strongly agree	2 16.7%
Disagree or strongly disagree	9 75%
Neutral	1 8.3%
Mssing	0 0%
Agree or strongly agree	1 8.3%
Disagree or strongly disagree	11 91.7%
Neutral	0 0%
Mssing	0 0%
Agree or strongly agree	7 58.3%
Disagree or strongly disagree	2 16.7%
Neutral	3 25%
Mssing	0 0%
Agree or strongly agree	9 75%
Disagree or strongly disagree	0 0%
Neutral	3 25%
Mssing	0 0%

2. Primary Outcome

Title	The System Usability Scale
Description	This 10 item questionnaire measures usability. Each item has 5 response options with total score ranging from 0 to 100. Higher values represent a better outcome.
Time Frame	Within an hour after using the application

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mobile Application
Arm/Group Description	Participants recruited from a self-management course are asked to use (single time) a mobile application to support reflection of personal strengths. The participant borrows an Ipad and uses the application to 1) reflect and identify their strengths by reviewing a list of examples, 2) define personal goals, and 3) link strengths to goals. Mobile application: Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals.
Measure Participants	12
Median (Full Range) [score on a scale]	86.3

3. Secondary Outcome

Title	The Positive and Negative Affect Schedule.
Description	This scale measures positive and negative affect with two subscales (positive affect and negative affect). Positive affect subscale scores can range from 10-50, with higher scores representing higher levels of positive affect. Negative affect subscale scores can range from 10-50, with lower scores representing lower levels of negative affect.
Time Frame	Pre-intervention and post-intervention, within an hour after using the application

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mobile Application
Arm/Group Description	Participants recruited from a self-management course are asked to use (single time) a mobile application to support reflection of personal strengths. The participant borrows an Ipad and uses the application to 1) reflect and identify their strengths by reviewing a list of examples, 2) define personal goals, and 3) link strengths to goals. Mobile application: Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals.
Measure Participants	12
Positive emotion sub scale (pre-intervention)	34.0
Positive emotion sub scale (post-intervention)	35.0
Negative emotion subscale (pre-intervention)	12.0
Negative emotion (post-intervention)	11.0

4. Secondary Outcome

Title	The Arthritis Self-efficacy Scale
Description	This scale measures self-efficacy with two subscales with 5 response options. The "pain" subscale has 5 items and a score range from 0 to 20. The "other symptoms" subscale has 6 items and a score range from 0 to 24. Higher scores equal higher levels of self-efficacy.
Time Frame	Pre-intervention and post-intervention, within an hour after using the application

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mobile Application
Arm/Group Description	Participants recruited from a self-management course are asked to use (single time) a mobile application to support reflection of personal strengths. The participant borrows an Ipad and uses the application to 1) reflect and identify their strengths by reviewing a list of examples, 2) define personal goals, and 3) link strengths to goals. Mobile application: Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals.
Measure Participants	12
Pain sub scale (pre-intervention)	12.0
Pain sub scale (post-intervention)	14.0
Other symptoms sub scale (pre-intervention)	16.0
Other symptoms subscale (post-intervention)	17.0

Adverse Events

Time Frame	Within about 1 hour from testing the application.
Adverse Event Reporting Description	Observations.
Arm/Group Title	Mobile Application
Arm/Group Description	Participants recruited from a self-management course are asked to use (single time) a mobile application to support reflection of personal strengths. The participant borrows an Ipad and uses the application to 1) reflect and identify their strengths by reviewing a list of examples, 2) define personal goals, and 3) link strengths to goals. Mobile application: Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals.
All Cause Mortality
	Mobile Application
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Serious Adverse Events
	Mobile Application
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Mobile Application
	Affected / at Risk (%)	# Events
Total	0/12 (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.