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)

BACKGROUND: Novel interactive and pictorial health education tool named Diabetes Conversation Map (DCM) might be effective for the improvement of diabetes management self-efficacy (DMSE) and diabetes distress (DD) among diabetic patients in lower middle-income setting. This study protocol will assess the effectiveness of DCM as compared to routine care (RC) to improve DMSE, decrease DD and glycated hemoglobin (HbA1c) among patients with type 2 diabetes (T2DM). METHODS: This will be two arms randomized controlled trial, conducted at national institute of diabetes and endocrinology (NIDE) in Karachi, Pakistan. A sample of 120 T2DM patients of age 30–60 years with suboptimal diabetes control will be screened through eligibility criteria and DD screening tool. Patients who fulfill the eligibility criteria and have diabetes distress will be randomized into interventional and control arm. The intervention arm will receive four education sessions (40 min each) using DCM for 4 weeks duration of enrollment. Controlled arm will receive RC. DMSE and DD will be measured using the validated Likert tools at baseline and after 3 months of enrollment. Latest results of HbA1c will be retrieved from the respective medical record files at baseline and 3 months. Change in DMSE, DD scores and HbA1c levels within groups (pre-post) and between the groups after 3 months of enrollment will be compared. Multivariable linear regression will be conducted to adjust for any potential confounders. DISCUSSION: In a study in UK, 70% of the patients with diabetes reported DCM had helped them in controlling their diabetes and recommended this method to teach other patients with diabetes also. In China, a study found that patients with diabetes who received DCM based education had significantly lower DD and significantly higher diabetes empowerment score after six months of the intervention as compared to the traditional counselling. A cross sectional study conducted in Pakistan also demonstrated that teaching based on DCM was useful in improving the knowledge, attitude and practices of patients with T2DM. Besides, no other study has evaluated the effectiveness of these novel tools for DMSE and diabetes distress DD in well-designed, sufficiently powered clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03747471. Date of registration: Nov 20. 2018. Version and Date of Protocol: Version 1, IRB Approval date 28 June 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12889-019-7266-3) contains supplementary material, which is available to authorized users.