Mobile Health Intervention for Improved Adherence in Type 2 Diabetes

NCT05291026 | Completed

• 1 other identifier: mH22000
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

mobile health; type 2 diabetes; adherence; health education; follow-up

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure

  Reduction in glycated hemoglobin (HbA1c), measured using blood tests, expressed in mmol/mol (%)

  6 Months

Secondary Outcomes (2)

• Secondary outcome measure I

  6 months

• Secondary outcome measure II

  6 months

Study Arms (2)

control group

NO INTERVENTION

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

intervention group

EXPERIMENTAL

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

Interventions

mobile phone-based health information OTHER

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)

Also known as: health education, follow-up messaging

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Obafemi Awolowo University: lead

Study Sites (1)

Obafemi Awolowo University Teaching Hospital Complex

Ile-Ife, Osun State, 234, Nigeria

Location

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MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Health Education

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kanayo Osemene, Ph.D.

  Department of Clinical Pharmacy and Pharmacy Administration, Obafemi Awolowo University, Ile Ife Nigeria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: March 22, 2022
• Study Start: December 15, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)