Clinical trial NCT05291026: Mobile Health Intervention for Improved Adherence in Type 2 Diabetes
Official title: Evaluation of mHealth Intervention to Improve Medication Adherence in Type 2 Diabetes in Nigeria: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: mobile health
type 2 diabetes
adherence
health education
follow-up
Lead sponsor: Obafemi Awolowo University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Eligibility criteria: 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.

Exclusion Criteria:

* Diagnosed of other disease conditions outside type 2 diabetes
* Below 18 years of age
* Not enrolled in the Out-patient Diabetes Clinic of the Teaching Hospital
* Did not give informed consent

Primary outcomes:
measure: Primary outcome measure
timeFrame: 6 Months
Secondary outcomes:
measure: Secondary outcome measure I
timeFrame: 6 months
measure: Secondary outcome measure II
timeFrame: 6 months
Other outcomes:
Locations:
city: Ile Ife
country: Nigeria
facility: Obafemi Awolowo University Teaching Hospital Complex
state: Osun
Study officials:
affiliation: Department of Clinical Pharmacy and Pharmacy Administration, Obafemi Awolowo University, Ile Ife Nigeria
name: Kanayo Osemene, Ph.D.
role: STUDY_DIRECTOR
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