Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202309636701102 Date of Approval: 15/09/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Type 2 Diabetes Mellitus Study in Vihiga County of Kenya
Official scientific title Use of Mass Text Messaging and Phone Calls to Improve Adherence, Glucose Control and Reduce adverse Outcomes in patients with Type 2 Diabetes Mellitus in Vihiga County of Kenya (2023-2024)
Brief summary describing the background and objectives of the trial Using mobile phone technology is an important aspect in tracking of patient progress in Type 2 Diabetes Mellitus – a chronic non-communicable disease. This can form an interface between health care providers and patients living with diabetes. With good adherence and acceptable glucose control, patients are highly likely to experience good prognosis while avoiding adverse health outcomes. Most patients living with Type 2 Diabetes Mellitus at least have some form of mobile device that can be used to communicate with friends and relatives. However the medical out-clinics are the only platforms for interaction between health care providers and patients. Patients attend monthly clinical reviews within a strained schedules, long queues and hence limited time for interaction. Mass texting and phone calls could probably bridge the gap between health care providers and patients. This study aims to explore the use of mass text messaging and phone calls to improve adherence, glucose control and reduce adverse health outcomes in T2DM patients. The study will also establish the association between glucose control, adherence factors and adverse health outcomes in T2DM patients at the Vihiga County Referral Hospital. The specific objectives include: 1) To determine the adherence factors in T2DM patients at the Vihiga County Referral Hospital; 2) To characterize cases of the T2DM mellitus patients at the Vihiga County Referral Hospital; 3) To assess the level of glucose control in T2DM patients at the Vihiga County Referral Hospital; 4) To establish the effect of the use of mass text messaging and phone calls on adherence and glucose control in T2DM patients at the Vihiga County Referral Hospital; 5) To evaluate the adverse health outcomes among T2DM patients at the Vihiga County Referral Hospital; 6) To establish the association between glucose control, adherence factors and adverse health outcomes in T2DM patients at the Vihiga County Referral Hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) T2DM
Disease(s) or condition(s) being studied Diabetes Mellitus
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 01/10/2023
Actual trial start date 01/10/2023
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date 31/12/2024
Anticipated target sample size (number of participants) 334
Actual target sample size (number of participants) 334
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ERC 39 08 23 31 01 Jaramogi Oginga Odinga University of Science and Technology, Ethics Review Committee
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mass text messaging and phone calls to patients with Type 2 Diabetes Mellitus Weekly text messaging (1 message per week) and monthly phone call (0ne call per month) 12 months The text messages and phone call intervention will be designed following a participatory and person-centered approach while making certain that the intervention is appropriate, evidence-based and obtainable to the study participants. The messages will be approved by the department of Health, in Vihiga County. The target participants will be involved in the drafting and testing of the consumer-centered mobile phone intervention through a series of official and unofficial group discussions, workshops and interviews. The intervention will include short text messages sent to the patients on a weekly basis and reminder phone calls on monthly basis for 12 months. The intervention includes the following components: 1. “Push” short text messages containing simple facts, inspirational messages and cues to action in T2DM. 2. “Pull” or on demand messages to allow participants to reach out just in time on areas of their concern. The designed messages will be loaded onto a telecommunication system in a scheduled order and sent automatically to the cluster of participants. Participants will be able to text assigned codes to access the pull messages with the cost of messaging incurred by the study. The information will only be accessible to the recruited participants in the intervention arm. 167
Control Group Routine services at the Medical Outpatient Clinic Usual monthly clinical review 12 months The control arm will continue to receive clinical review services at the monthly out patient clinic at the Vihiga County Referral Hospital. 167 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged between 30-75 years of age diagnosed with T2DM Patients attending the Vihiga County Referral Hospital as their choice facility of follow-up Patients who consent to participate in the study Patients with access to mobile phone device Patients declining to consent to participate in the study Patients without access to a mobile phone device Transit or one time visit patients Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/08/2023 Jaramogi Oginga Odinga University of Science and Technology Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Bondo Bondo 40601 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to care and treatment At baseline, at midline - 6 months after enrolment into the study and at endline - 12 months after enrolment into the study
Secondary Outcome Glucose control measured by the levels of glycated hemoglobin At baseline, at midline - 6 months after enrolment into the study and at endline - 12 months after enrolment into the study
Secondary Outcome Reduced adverse health outcomes measured as frequency of occurrence of complications At baseline, at midline - 6 months after enrolment into the study and at endline - 12 months after enrolment into the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Vihiga County Referral Hospital Hospital Road, Mbale Town Mbale 50300 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Researchers contributions Vihiga County Headquarters Mbale 50300 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor To be filled on determination a few approached Nil To be determined Kenya Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr Benjamin Induswe Vihiga County Headquarters Mbale 50300 Kenya
Dr Victor Zimbulu Vihiga County Referral Hospital Mbale 50300 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jerusa Oluhano jeruhano@gmail.com +254710888103 Hospital road, Mbale Town
City Postal code Country Position/Affiliation
Mbale 50300 Kenya County Pharmacist for the County Government of Vihiga
Role Name Email Phone Street address
Public Enquiries Mike Endovo mikeolonyo2@gmail.com +254704301792 Hospital Road Mbale Town
City Postal code Country Position/Affiliation
Mbale 50300 Kenya County NonCommunicable Diseases Coordinator for the County Government of Vihiga
Role Name Email Phone Street address
Scientific Enquiries Collins Mudogo collinsmukanya@gmail.com +254726095677 Vihiga County Headquarters Mbale Town
City Postal code Country Position/Affiliation
Mbale 50300 Kenya Head of Division Health Information Monitoring Evaluation and Research for the County Government of Vihiga
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The researchers will endeavor to share deidentified and aggregate data. No individual participant data that can be used to trace specific participants in the study shall be shared. Clinical Study Report 6 months Researchers, academia, programs implementing in the area of diabetes, health professionals.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information