Nurse-Led Multidisciplinary Care for Type 2 Diabetes: Protocol for a Feasibility Pilot Randomized Controlled Trial

Fatemeh  Bakhshi; Reyhaneh  Azizi; Mahdieh  Hossienzadeh; Shakiba Sadat  Tabatabaee; Zahra  Ramezani

doi:10.18502/ijdo.v18i1.21060

Fatemeh Bakhshi Assistant Professor, Ph.D. In Nursing Education. Research Center for Nursing and Midwifery Care, Comprehensive Research Institute for Maternal and Child Health, Department of Nursing, School of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Reyhaneh Azizi Assistant Professor, Diabetes Research Center, Non-Communicable Diseases Research Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Mahdieh Hossienzadeh Associate Professor, Research Center for Food Hygiene and Safety, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.Diabetes Research Center, Non-Communicable Diseases Research Institute, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Shakiba Sadat Tabatabaee PhD Candidate in Psychology, Kish International Campus, University of Tehran, Tehran, Iran
Zahra Ramezani MSc Student of Medical Surgical Nursing, Department of Nursing, School of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd, Ira

DOI: https://doi.org/10.18502/ijdo.v18i1.21060

Keywords: Diabetes mellitus, Nurses; Multidisciplinary, Medication adherence, Self-management

Abstract

Objective: To assess the feasibility of a nurse-led multidisciplinary intervention to improve self- management, psychological distress, and medication adherence in patients with type 2 diabetes (T2D) in Iran, informing a future definitive randomized controlled trial (RCT).

Materials and Methods: This single-blind, parallel-group pilot RCT will recruit 60 adults with T2D (HbA1c> 6.5%) from the Yazd Diabetes Research Center, Iran. Participants will be randomized 1:1 to a 6‑month intervention or usual care. The intervention, grounded in self-efficacy theory and motivational interviewing, comprises 3 months of in-person/online counseling (three sessions targeting American Diabetes Association–endorsed self-care behaviors: diabetes knowledge, nutrition counseling, physical activity, glucose monitoring, medication adherence, and cardiovascular risk reduction) delivered by a nurse-led team (endocrinologist, dietitian, psychologist), followed by 3 months of biweekly telephone follow-ups. Feasibility outcomes include recruitment (>70%), retention (>80%), acceptability (Likert score >4/5), and data completeness (>90%). Exploratory outcomes include HbA1c, fasting blood sugar, low-density lipoprotein, blood pressure, anthropometric indices, dietary self-management assessed by the Diabetes Self-Management Questionnaire-Revised, diabetes-related distress measured by the Diabetes Distress Scale-17, and medication adherence evaluated by the Medication Adherence Report Scale-5, collected at baseline, 3 months, and 6 months. Data will be analyzed descriptively (proportions, means, 95% CIs) using SPSS v25.

Results: It is merely a proposed research protocol that can be used in the future.

Conclusion: This pilot will evaluate the feasibility of a culturally tailored, nurse-led multidisciplinary intervention for T2D management in Iran, providing data to refine a definitive RCT and inform care models in resource-constrained settings