Mobile Health Intervention for Improved Adherence in Type 2 Diabetes

Sponsor

Obafemi Awolowo University (Other)

Overall Status

Completed

CT.gov ID

NCT05291026

Collaborator

(none)

120

Enrollment

Location

Arms

6.5

Actual Duration (Months)

18.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study assessed patients' glycemic control, knowledge of type 2 diabetes (T2D) and adherence to medications, and evaluated the impact of a mobile telephone-based intervention on these indices. Patients' clinic attendance and pharmacy refill records were reviewed for the period of 1 year. Then over a period of 1 month, newly diagnosed T2D patients were enrolled in the prospective phase of the study and randomized into control and intervention groups. A mobile phone-based health education and follow-up package was applied to the intervention group alone for a period of 6 months. Afterwards, both groups were assessed and compared on the study outcome parameters. Same questionnaires were used pre- and post-intervention for primary data collection. Descriptive and inferential statistics were used for data analysis.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Other: mobile phone-based health information	N/A

Detailed Description

Objectives of the Study: The study assessed patients' glycemic control, knowledge of type 2 diabetes (T2D) and adherence to medications, and evaluated the impact of a mobile telephone-based intervention on these indices.

Study design: Randomized controlled trial Study Setting: Diabetes Clinic, Endocrinology Unit, Department of Internal Medicine, Obafemi Awolowo University Teaching Hospital Ile Ife, Osun

State Nigeria The study was structured in five stages. Study Duration: Seven months Stage 1:

Baseline data Task 1: Baseline data for patients' glycemic control were obtained from one-year retrospective review of 1392 patients' files for glycated haemoglobin (HbA1c) measurements.

Task 2: Patients' baseline adherence data were obtained from one-year retrospective review of pharmacy refill records (clinic attendance) Task 3: Development and validation of research instruments (Questionnaires, Short Message Services (SMS).

Task 4: Recruitment and training of research assistants (2 hours daily for 3 days) Stage 2:

Recruitment and randomization of participants Task 1: Enrolment of all newly-diagnosed patients (n = 120), enrolled in the Diabetes Clinic in the period of one month following Stage 1 Task 2: Obtaining of informed consent from all newly-diagnosed patients enrolled in the Diabetes Clinic in the one month following Stage 1 Task 3: Collection of participants' baseline knowledge data using structured questionnaire Task 4: Collection of baseline self-reported adherence data using the adapted 8-point Morisky Medication Adherence Scale (MMAS-8) instrument Task 5: Randomization of consenting participants into two equal (n = 60) control and intervention groups using a randomization software Stage 3: Intervention Task 1: Activation of short message services to participants in the intervention cohort at a frequency of one message per day for the period of 6 months.

Task 2: Follow up on clinic attendances of all participants for the period of 6 months Stage 4: Post-Intervention Review Task 1: Repeat administration of same questionnaires originally administered at Stage 2 to all participants Task 1: Review of participants' clinic attendance and pharmacy refill records Task 2: Review of participants HbA1c measurements from their records Stage 5: Data analysis Task 1: Demographic variables of participants were analyzed using descriptive statistics including frequency and percentages Task 2: Weighted mean scores were used to analyze knowledge and adherence scores Task 3: Two-sample t-test was used to compare pre- and post-intervention scores of knowledge and adherence Task 4: Chi square test was conducted to analyze associations between demographic variables and self-reported adherence data Task 5: Statistical package for the social sciences (SPSS) version 21 for windows software was used for data analysis at the p < 0.05 level of significance

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

All newly-diagnosed type 2 diabetes patients within the one month period following the retrospective document review, were enrolled, provided they gave their informed consent. Study participants were randomly assigned to either of two equal-sized control and intervention cohorts. The Randomizer App software was used to assign participants to the control and intervention groups. The control group received standard of care only. The intervention group received the standard of care in addition to the mobile phone-based health education and follow-up messaging at the frequency of once daily for 6 months.All newly-diagnosed type 2 diabetes patients within the one month period following the retrospective document review, were enrolled, provided they gave their informed consent. Study participants were randomly assigned to either of two equal-sized control and intervention cohorts. The Randomizer App software was used to assign participants to the control and intervention groups. The control group received standard of care only. The intervention group received the standard of care in addition to the mobile phone-based health education and follow-up messaging at the frequency of once daily for 6 months.

Masking:

Double (Participant, Care Provider)

Masking Description:

Participants knew neither the identity nor the group placement of other participants. The clinicians who provided care for the participants did not know the identity or the group placement of the participants. Investigators/ Outcome assessors were not among the care givers and did not interface physically with either caregivers or study participants.

Primary Purpose:

Health Services Research

Official Title:

Evaluation of mHealth Intervention to Improve Medication Adherence in Type 2 Diabetes in Nigeria: a Randomized Controlled Trial

Actual Study Start Date :

Dec 15, 2018

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control group Type 2 diabetes patients, 18 years old and above, enrolled in the out-patient, diabetes clinic of the tertiary health facility, receiving only standard of care, and who gave their informed consent
Experimental: intervention group type 2 diabetes patients, 18 years old and above, enrolled in the out-patient diabetes clinic of the tertiary health facility, receiving standard of care in addition to a mobile phone - based health education and follow-up messaging on a frequency of once a day corresponding to how often they are expected to take their medications (that is every day), and who gave their informed consent.	Other: mobile phone-based health information health education and follow-up messaging, randomly assigned to each participant in the intervention arm using a randomization software, delivered once daily, as short message service (sms) Other Names: health education, follow-up messaging

Arm

Intervention/Treatment

No Intervention: control group

Type 2 diabetes patients, 18 years old and above, enrolled in the out-patient, diabetes clinic of the tertiary health facility, receiving only standard of care, and who gave their informed consent

Experimental: intervention group

type 2 diabetes patients, 18 years old and above, enrolled in the out-patient diabetes clinic of the tertiary health facility, receiving standard of care in addition to a mobile phone - based health education and follow-up messaging on a frequency of once a day corresponding to how often they are expected to take their medications (that is every day), and who gave their informed consent.

Other: mobile phone-based health information

health education and follow-up messaging, randomly assigned to each participant in the intervention arm using a randomization software, delivered once daily, as short message service (sms)

Other Names:

health education, follow-up messaging

Outcome Measures

Primary Outcome Measures

Primary outcome measure [6 Months]
Reduction in glycated hemoglobin (HbA1c), measured using blood tests, expressed in mmol/mol (%)

Secondary Outcome Measures

Secondary outcome measure I [6 months]
Knowledge of diabetes, measured as by the mean score of participants in a questionnaire-based survey
Secondary outcome measure II [6 months]
Adherence to medication, measured by the mean score of participants in a questionnaire-based survey

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed of type 2 diabetes for the first time in the month following baseline study
Male or female, 18 yeas of age and above
Enrolled in the Out-patient Diabetes Clinic of the Teaching Hospital
Gave informed consent to participate.