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Mobile Health Intervention for Improved Adherence in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05291026
Recruitment Status : Completed
First Posted : March 22, 2022
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Madu Ihekoronye, Obafemi Awolowo University

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
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.
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 : December 15, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


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 Name: health education, follow-up messaging




Primary Outcome Measures :
  1. Primary outcome measure [ Time Frame: 6 Months ]
    Reduction in glycated hemoglobin (HbA1c), measured using blood tests, expressed in mmol/mol (%)


Secondary Outcome Measures :
  1. Secondary outcome measure I [ Time Frame: 6 months ]
    Knowledge of diabetes, measured as by the mean score of participants in a questionnaire-based survey

  2. Secondary outcome measure II [ Time Frame: 6 months ]
    Adherence to medication, measured by the mean score of participants in a questionnaire-based survey



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05291026


Locations
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Nigeria
Obafemi Awolowo University Teaching Hospital Complex
Ile Ife, Osun, Nigeria, 234
Sponsors and Collaborators
Obafemi Awolowo University
Investigators
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Study Director: Kanayo Osemene, Ph.D. Department of Clinical Pharmacy and Pharmacy Administration, Obafemi Awolowo University, Ile Ife Nigeria
Publications:
World Health Organization. Diabetes [Internet]. World Health Organisation, Geneva Switzerland; 2018. Available from: https://www.who.int/news-room/factsheets/ detail/diabetes
World Health Organisation. World malaria report 2015. World Health Organisation, Geneva Switzerland; 2016.
Harande Y. Exploring the Literature of Diabetes in Nigeria: A Bibliometrics Study. African Journal of Diabetes Medicine. 2011; 2:1-4.
Ramaj A, Kamberi F, Behrens J. Effects of Diabetes Education on Emotional Distress in Patients with Type 2 Diabetes-An Experimental Study. Open Journal of Endocrine and Metabolic Diseases. 2019 Feb 19; 9(2):9-20.
World Health Organization. Long Term-Therapies: Evidence for Action [Internet]. World Health Organisation, Geneva Switzerland; 2003. Available from: ISBN 92-4-154599-2
NB of S (NBS). Nigeria GDP data, Q1, Q2 2021 [Internet]. 17. National Bureau of Statistics (NBS). 2021 [cited 2022 Jan 10]. Available from: https://nigerianstat.gov.ng/elibrary
Davis F, Davis F. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Quarterly. 1989 Sep 1; 13:319.
Taber KS. The Use of Cronbach's Alpha When Developing and Reporting Research Instruments in Science Education. Res Sci Educ. 2018 Dec 1; 48(6):1273-96
Erdoğan Ö, Araman A. Health beliefs and functional health literacy; Interaction with the pharmaceutical services. Istanbul Journal of Pharmacy. 2017 Oct 18; 47:68-71.
Centers for Disease Control (CDC). National Diabetes Statistics Report 2020. Estimates of diabetes and its burden in the United States. [Internet]. Centers for Disease Control (CDC); 2020 [cited 2022 Jan 10]. Available from: https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf
Ekpenyong C, Akpan U, Ibu J, Nyebuk D. Gender and age specific prevalence and associated risk factors of type 2 diabetes mellitus in Uyo metropolis, South Eastern Nigeria. DiabetologiaCroatica [Internet]. 2012;41(1). Available from: http://www.sciepub.com/reference/340492
Ajisegiri WS, Abimbola S, Tesema AG, Odusanya OO, Ojji DB, Peiris D, et al. Aligning policymaking in decentralized health systems: Evaluation of strategies to prevent and control non-communicable diseases in Nigeria. PLOS Global Public Health. 2021 Nov 10; 1(11):e0000050.
International Diabetes Federation. IDF. Clinical practice recommendations for managing type 2 diabetes in primary care. [Internet]. [Cited 2021 Oct 19]. Available from: https://www.idf.org/e-library/guidelines/128-idf-clinical-practice-recommendations-formanaging- type-2-diabetes-in-primary-care.html.

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Responsible Party: Madu Ihekoronye, Lecturer, Obafemi Awolowo University
ClinicalTrials.gov Identifier: NCT05291026    
Other Study ID Numbers: mH22000
First Posted: March 22, 2022    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Madu Ihekoronye, Obafemi Awolowo University:
mobile health
type 2 diabetes
adherence
health education
follow-up
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases