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.: PACTR202106626595700 Date of Approval: 01/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of motivational interviewing on glycemic control, self-care management and diabetes related distress among people with type 2 diabetes mellitus in Tigray region, Ethiopia: a randomized controlled trial
Official scientific title Effect of MI on glycemic control, self- management and diabetes related distress among people with TDM
Brief summary describing the background and objectives of the trial Background: According to the 2011 report of the IDF, the number of adults living with diabetes in Ethiopia was 3.5%. To promote optimal glycemic control through self-management, it is important to understand the level to which people with diabetes integrate self-care managements into their lives. Many intervention studies have targeted the effect of diabetes education on self-management. Further, some studies identified factors that inhibiting the management of diabetes, but, a few evaluated the outcomes. Moreover, some studies in this area suffer from one or more methodological limitations. Objective: The Aim of this study will be to identify whether participation in a motivational interview for people with type 2 diabetes improve their self-management, diabetes related distress and glycemic outcomes in Tigray region, Ethiopia, 2021/22. Methods: randomized clinical trial study design will be used. A total of 160 participants will be included in the study. participants will be selected using simple random sampling procedure form each cluster and study population will be all adults of >18 years old who have been diagnosed with T2DM. Moreover, glycemic control will be assessed using HbA1c test and data related to efficacy of self-care management and diabetes related distress will be collected using interviewer administered standardized questionnaires. Data entry and analyses will be done using STATA Version 14. Analyses of outcomes will be performed with the use of paired t-test within group and unpaired t-test between groups. ANCOVAs methods will be used to compare change differences between the intervention and control groups after the MI intervention. A two-tailed p-value with equal variances assumed < 0.05 will be considered statistically significant. Budget & study period: The total budget for this project is 197,800.00 Birr and the study period will be June. 2021 to Dec. 2022
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/06/2021
Actual trial start date 01/07/2021
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date 31/01/2022
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL https://journals.plos.org
Secondary Ids Issuing authority/Trial register
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Dynamic (adaptive) random allocation such as minimization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group usual care six times 30 minutes All participants in this group will received the usual care such as routine lab tests (e.g. FBS, urine), BP & weight checks, individual diabetes self-management education and clinical evaluation 80 Placebo
Experimental Group MOTIVATIONAL INTERVIEWING six times 30 minutes Motivational interviewing is behavioral intervention defied as directive, client-centered counseling style for eliciting behavior change by helping clients to explore and resolve ambivalence. It is: “...a collaborative, person- ‐centered form of guiding to elicit and strengthen motivation for change.” 80
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Diagnosed with Type 2 diabetes • Age above 19 years old • Three months and above Clinical follow • Able to consent for participation • People with gestational diabetes, • pregnant women, • people with cognitive problem or critically ill. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 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 20/05/2021 Institutional Review Board or IRB
Ethics Committee Address
Street address City Postal code Country
Not available Mekelle 1871 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • HgbA1C At base line and end line
Secondary Outcome • Diabetes related distress At base line and end line
Secondary Outcome • Self-management competence At base line and end line
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ayder comprhensive specialized hospital Not available Mekelle 1871 Ethiopia
Mekelle general hospital Mizer Mekelle Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Mekelle university recurrent budget Not available Mekelle 1871 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mekelle university Not available Mekelle 1871 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Ayder comprhensive specialized hospital Not available Mekelle 1871 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kalayou Berhe kalushaibex@gmail.com +251912117719 Not available
City Postal code Country Position/Affiliation
Mekelle 1871 Ethiopia PhD student and faculty member at Mekelle university college of health sciences school of nursing
Role Name Email Phone Street address
Scientific Enquiries Haftu Gebru haftuber@yahoo.com +251914725835 Not available
City Postal code Country Position/Affiliation
Mekelle 1871 Ethiopia Faculty member at Mekelle university college of health sciences school of nursing
Role Name Email Phone Street address
Public Enquiries Hailemariam Kahsay aidhbk@gmail.com +251914707632 Not available
City Postal code Country Position/Affiliation
Mekelle 1871 Ethiopia faculty member at Mekelle university college of health sciences school of nursing
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected during the trial will be shared and available immediately following publication with no end date to anyone who wishes to access to be used for any purpose of data analysis and will be available indefinitely at the journal web site after publication. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available immediately following publication and no end date and The data will be available to anyone who wishes to access (Open access) and will be used for any purpose of data analysis. The data will be available indefinitely at the journal web site after publication, sharing permission will be decided by Principal investigator and quality of request will be used as criteria for reviewing requests.
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