Conversation Map and Diabetes in Pakistan (DAMP)
|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: NCT03747471|
Recruitment Status : Completed
First Posted : November 20, 2018
Last Update Posted : July 17, 2019
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
Background Diabetes is recognized as an important cause of premature death and disability. Non-clinical interventions play an important role in the control of diabetes and the prevention of its associated complications. Traditional methods of educating diabetic patients to empower them for the control of their disease might not work in the developing world. However, the novel interactive and pictorial health education tool named Diabetes Conversation Map (DCM) might be effective for the improvement of diabetes management self-efficacy and distress among diabetic patients in lower middle income setting of Karachi, Pakistan.
Objective To assess the effectiveness of DCM as compared to routine care to improve the diabetes management self-efficacy (DMSE) and diabetic distress (DD) among type 2 diabetic patients (T2DM) visiting diabetic clinics of tertiary care hospitals in lower middle income setting of Karachi, Pakistan.
Methodology This will be a two arms randomized controlled trial, conducted in two tertiary care hospitals, Karachi. A sample of 120 T2DM patients of age 30 - 60 years with sub-optimal diabetes control will be screened through eligibility criteria and diabetes distress screening tool. Patients who fulfill the eligibility criteria and have diabetes distress will be randomized into intervention (n=60) and control group (n=60) using sealed envelopes. The intervention arm will receive four diabetic education sessions using the DCM in a group of 5-8 participants and each session will be at the interval of one (1) week, by the principal investigator. T2DM patients in the controlled arm will receive routine care. Data on DMSE and DD will also be measured 2-3 months post intervention after the completion of all education sessions. Descriptive statistics will be used for data analysis through SPSS version 20; whereas, application of Repeated Measures ANOVA will be carried out for inferential statistics.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Diabetes Self Efficacy Diabetes Mellitus, Type 2||Behavioral: Diabetic Conversation Map||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This will be a 2 arms individual randomized controlled trial. Intervention arm will receive teaching from the nurses using diabetic conversation map with visual images and control arm will receive teaching from the nurses using the traditional diabetic counselling.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effect of Conversation Map on Diabetes Management Self-efficacy and Diabetic Distress Among Type 2DM Patient in Pakistan: A Randomized Controlled Trial|
|Actual Study Start Date :||January 1, 2019|
|Actual Primary Completion Date :||February 1, 2019|
|Actual Study Completion Date :||April 30, 2019|
Experimental: Experimental Arm
Intervention: Diabetic Conversation Map x 4 Sessions
Behavioral: Diabetic Conversation Map
Diabetic Conversation Map education tools are a series of tools for facilitated group education 5-8that were developed by Healthy Interactions in collaboration with the International Diabetes Federation (IDF) and are sponsored by Lilly Diabetes.
CM-based education guides people with diabetes through a process with the aim of helping them understand and internalize information about their disease and generate insightful conclusions, which may then result in improved self-management decisions and actions.
No Intervention: Control Arm
- Change from baseline Diabetes Management Self-Efficacy (DMSE) at 3 months: [ Time Frame: at baseline and after 3 months of enrollment ]The change in DMSE will be measured using validated DMSE scale. The scale has 20 items comprised of 4 domains; 1) nutrition specific and weight, 2) medical treatment, 3) physical exercise, 4) blood sugar. Each item is scored on 11 point likert scale (0=completely unable to 10=completely able). Possible score ranges from 0 to 200, with higher score representing higher self-efficacy.
- Change from baseline Diabetes distress (DD) 3 months: [ Time Frame: baseline and 3 months of enrollment ]The change in DD will be screened using validated DD scale. The scale has two parts; part 1 is consisting of two items asking about feelings of overburden due to demands of living with diabetes and feelings of failure with diabetes routine; the aim of part 1 is to screen for the presence of DD. Part 1 will be administered before the enrollment of the patient to screen for the presence of DD. If DD is present, part 2 will begin consisting of 17 items to score the extent of DD. Each item is scored on a likert scale ranging from 1 (not a problem) to 6 (a very serious problem). According to the instructions of DDS scoring sheet, total DDS will be measured with mean score while dividing the sum of all items by 17.The mean score of ≥3 will be the threshold for being distressed.
- Change from baseline HbA1C at 3 months: [ Time Frame: baseline and 3 months after enorllment ]Change in HbA1c level will be measured at baseline and 3 months after enrollment to see mean difference in the two measurements
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.
|Ages Eligible for Study:||30 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- All patients of both gendersage 30-60 years diagnosed with type 2 diabetes mellitusfor at least 5 years, presenting at the diabetes clinics of study setting and considered by health care professional to have a suboptimal management of their disease.
- Patient having HbA1c more than 7 will be included
- Patients who have not participated in any diabetic educational program before.
- Patients who will be found to be diabetes distressed as recommended in diabetes distress (DD) screening tool
- Patients with major disabilities, diagnosed with mental health problems/ cognitive pattern not intact and those with major diabetes related complications.
- Patients residing outside of Karachi or intended to leave the city during the study duration will be excluded.
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): NCT03747471
|Dow University of Health Sciences|
|Karachi, Sindh, Pakistan|
|Principal Investigator:||Rubina Qasim, MSc||Dow University of Health Sciences, Ojha Campus|
|Responsible Party:||Rubina Qasim, Lecturer, Dow University of Health Sciences|
|Other Study ID Numbers:||
|First Posted:||November 20, 2018 Key Record Dates|
|Last Update Posted:||July 17, 2019|
|Last Verified:||July 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Type 2 Diabetes mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases