Conversation Map and Diabetes in Pakistan

NCT03747471 | Completed

• 1 other identifier: ruby1234
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus; Diabetes; Self Efficacy; Diabetes Mellitus, Type 2

Keywords

Diabetes; Type 2 Diabetes mellitus; Health Education; Conversation Map; Developing countries

Outcome Measures

Primary Outcomes (2)

• Change from baseline Diabetes Management Self-Efficacy (DMSE) at 3 months:

  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.

  at baseline and after 3 months of enrollment

• Change from baseline Diabetes distress (DD) 3 months:

  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.

  baseline and 3 months of enrollment

Secondary Outcomes (1)

• Change from baseline HbA1C at 3 months:

  baseline and 3 months after enorllment

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Intervention: Diabetic Conversation Map x 4 Sessions

Behavioral: Diabetic Conversation Map

Control Arm

NO INTERVENTION

No intervention

Interventions

Diabetic Conversation Map BEHAVIORAL

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.

Experimental Arm

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rubina Qasim: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Location

Related Publications (2)

• Qasim R, Masih S, Yousafzai MT, Shah H, Manan A, Shah Y, Yaqoob M, Razzaq A, Khan A, Rohilla ARK. Diabetes conversation map - a novel tool for diabetes management self-efficacy among type 2 diabetes patients in Pakistan: a randomized controlled trial. BMC Endocr Disord. 2020 Jun 16;20(1):88. doi: 10.1186/s12902-020-00572-x.

  PMID: 32546240 DERIVED

• Qasim R, Masih S, Hussain M, Ali A, Khan A, Shah Y, Shah H, Yousafzai MT. Effect of diabetic counseling based on conversation map as compared to routine counseling on diabetes management self-efficacy and diabetic distress among patients with diabetes in Pakistan: a randomized controlled trial (study protocol). BMC Public Health. 2019 Jul 8;19(1):907. doi: 10.1186/s12889-019-7266-3.

  PMID: 31286927 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Health Education

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Rubina Qasim, MSc

  Dow University of Health Sciences, Ojha Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 20, 2018
• Study Start: January 1, 2019
• Primary Completion: February 1, 2019
• Study Completion: April 30, 2019
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)