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Conversation Map and Diabetes in Pakistan

NCT03747471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-07-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Rubina Qasim

    lead OTHER

Principal Investigators

  • Rubina Qasim, MSc · Dow University of Health Sciences, Ojha Campus

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2019-02-01
Completion
2019-04-30

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03747471 on ClinicalTrials.gov