Iranian Journal of Diabetes and Obesity
Shahid Sadoughi University Of Medical Sciences
Thu, Feb 19, 2026
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Volume 18, Issue 1 (2-2026)
IJDO 2026, 18(1): 41-52 |
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Bakhshi F, Azizi R, Hossienzadeh M, Tabatabaee S S, Ramezani Z. Nurse-Led Multidisciplinary Care for Type 2 Diabetes: Protocol for a Feasibility Pilot Randomized Controlled Trial. IJDO 2026; 18 (1) :41-52
URL: http://ijdo.ssu.ac.ir/article-1-1016-en.html
URL: http://ijdo.ssu.ac.ir/article-1-1016-en.html
Fatemeh Bakhshi 
, Reyhaneh Azizi , Mahdieh Hossienzadeh , Shakiba Sadat Tabatabaee , Zahra Ramezani *
, Reyhaneh Azizi , Mahdieh Hossienzadeh , Shakiba Sadat Tabatabaee , Zahra Ramezani *
MSc Student of Medical Surgical Nursing, Department of Nursing, School of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Abstract: (40 Views)
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.
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.
Type of Study: Research |
Subject:
Special
Received: 2025/10/9 | Accepted: 2025/12/17 | Published: 2026/02/21
Received: 2025/10/9 | Accepted: 2025/12/17 | Published: 2026/02/21
References
1. Budreviciute A, Damiati S, Sabir DK, Onder K, Schuller-Goetzburg P, et al. Management and prevention strategies for non-communicable diseases (NCDs) and their risk factors. Frontiers in public health. 2020;8:574111. [DOI:10.3389/fpubh.2020.574111]
2. Subramanian SC, Porkodi A, Akila P. Effectiveness of nurse-led intervention on self-management, self-efficacy and blood glucose level among patients with Type 2 diabetes mellitus. Journal of Complementary and Integrative Medicine. 2020;17(3):20190064. [DOI:10.1515/jcim-2019-0064]
3. Khanjani Movaghar S, Khazaei S, Borzouei S. Evaluation of medication adherence and its related factors among type 2 diabetic patients. Avicenna Journal of Clinical Medicine. 2021;28(3):158-65. [DOI:10.52547/ajcm.28.3.158]
4. Ali MK, Pearson-Stuttard J, Selvin E, Gregg EW. Interpreting global trends in type 2 diabetes complications and mortality. Diabetologia. 2022;65(1):3-13. [DOI:10.1007/s00125-021-05585-2]
5. Jafarvand E, Ataey A, Edalati S. Epidemiology and death trends due to diabetes in Iran. Internal Medicine Today. 2021;27(2):198-213. [DOI:10.32598/hms.27.2.2764.1]
6. Tomic D, Shaw JE, Magliano DJ. The burden and risks of emerging complications of diabetes mellitus. Nature Reviews Endocrinology. 2022;18(9):525-39. [DOI:10.1038/s41574-022-00690-7]
7. Png ME, Yoong J, Phan TP, Wee HL. Current and future economic burden of diabetes among working-age adults in Asia: conservative estimates for Singapore from 2010-2050. BMC public Health. 2016;16(1):153.
https://doi.org/10.1186/s12889-016-2827-1 [DOI:10.1186/s12889-016-3164-0]
8. Tan E, Khoo J, Gani LU, Malakar RD, Tay TL, Tirukonda PS, et al. Effect of multidisciplinary intensive targeted care in improving diabetes mellitus outcomes: a randomized controlled pilot study-the integrated diabetes education, awareness and lifestyle modification in Singapore (IDEALS) program. Trials. 2019;20(1):549. [DOI:10.1186/s13063-019-3601-3]
9. Chepulis L, Morison B, Cassim S, Norman K, Keenan R, Paul R, et al. Barriers to diabetes self‐Management in a Subset of New Zealand adults with type 2 diabetes and poor Glycaemic control. Journal of diabetes research. 2021;2021(1):5531146. [DOI:10.1155/2021/5531146]
10. Yoon S, Ng JH, Kwan YH, Low LL. Healthcare professionals' views of factors influencing diabetes self-management and the utility of a mHealth application and its features to support self-care. Frontiers in Endocrinology. 2022;13:793473. [DOI:10.3389/fendo.2022.793473]
11. Heydari M, Karimi K, Khodaveisi T. The Roles and Challenges of Mobile Health Apps in the Management of Type 2 Diabetes. Journal of Modern Medical Information Sciences. 2023;9(1):2-7.(in Persian)
12. Vainauskienė V, Vaitkienė R. Enablers of patient knowledge empowerment for self-management of chronic disease: an integrative review. International journal of environmental research and public health. 2021;18(5):2247. [DOI:10.3390/ijerph18052247]
13. Bassi G, Gabrielli S, Donisi V, Carbone S, Forti S, Salcuni S. Assessment of psychological distress in adults with type 2 diabetes mellitus through technologies: literature review. Journal of medical Internet research. 2021;23(1):e17740. [DOI:10.2196/17740]
14. Ayoubi J, Bigdeli I, Mashhadi AJ. The effect of mindfulness-integrated cognitive behavior therapy on quality of life, psychological distress and adherence in patients with type 2 diabetes mellitus. Quarterly Journal Of Healthpsychology. 2020;9(34):75-94.(in Persian)
15. Lee DS, Lee H. Adherence and persistence rates of major antidiabetic medications: a review. Diabetology & Metabolic Syndrome. 2022;14(1):12. [DOI:10.1186/s13098-022-00785-1]
16. Gow K, Rashidi A, Whithead L. Factors influencing medication adherence among adults living with diabetes and comorbidities: a qualitative systematic review. Current diabetes reports. 2024;24(2):19-25. [DOI:10.1007/s11892-023-01532-0]
17. Johnson JM, Carragher R. Interprofessional collaboration and the care and management of type 2 diabetic patients in the Middle East: A systematic review. Journal of interprofessional care. 2018;32(5):621-8. [DOI:10.1080/13561820.2018.1471052]
18. Gulley T, Cole R, Subbanna M, Ratliff CC, Hill-Collins P, Tyson T. Interprofessional collaboration to improve care for patients with diabetes. The Nurse Practitioner. 2024;49(5):34-9. [DOI:10.1097/01.NPR.0000000000000175]
19. Baggs JG. Interprofessional, interdisciplinary, or multidisciplinary?. American Journal of Critical Care. 2022;31(1):7. [DOI:10.4037/ajcc2022459]
20. Karam M, Chouinard MC, Poitras ME, Couturier Y, Vedel I, Grgurevic N, et al. Nursing care coordination for patients with complex needs in primary healthcare: a scoping review. International journal of integrated care. 2021;21(1):16. [DOI:10.5334/ijic.5518]
21. Zuo M, Zhu W, Lin J, Zhuo J, He X, Jing X, et al. The impact of nurse-led nonpharmacological multidisciplinary holistic nursing care on fatigue patients receiving hemodialysis: a randomized, parallel-group, controlled trial. BMC nursing. 2022;21(1):352. [DOI:10.1186/s12912-022-01126-3]
22. Nayeri ND, Samadi N, Mehrnoush N, Allahyari I, Bezaatpour F, NaseriAsl M. Experiences of nurses within a nurse-led multidisciplinary approach in providing care for patients with diabetic foot ulcer. Journal of Family Medicine and Primary Care. 2020;9(6):3136-41. [DOI:10.4103/jfmpc.jfmpc_1008_19]
23. Schentrup D, Black EW, Blue A, Whalen K. Interprofessional teams: lessons learned from a nurse-led clinic. The Journal for Nurse Practitioners. 2019;15(5):351-5. [DOI:10.1016/j.nurpra.2019.02.016]
24. Davari M, Bayazidi Y, Kebriaeezadeh A, Esteghamati A, Bandarian F, Kashi Z, et al. Quality of care in type 2 diabetes in Iran; a cross-sectional study using patient-level data. BMC Endocrine Disorders. 2022;22(1):133. [DOI:10.1186/s12902-022-01034-2]
25. Aalaa M, Sanjari M, Mohajeri-Tehrani MR, Mehrdad N, Amini MR. A multidisciplinary team approach in Iranian diabetic foot research group. Journal of Diabetes & Metabolic Disorders. 2019;18(2):721-3. [DOI:10.1007/s40200-019-00450-x]
26. Arjunan P, Ramakrishnan TV, Gandhamaneni S. Characteristics and survival rates of patients experience in-hospital cardiac arrest: a retrospective study in a tertiary care Indian hospital. Bangladesh Journal of Medical Science. 2020;19(3):537-42. [DOI:10.3329/bjms.v19i3.45872]
27. Mizukawa M, Moriyama M, Yamamoto H, Rahman MM, Naka M, Kitagawa T, et al. Nurse-led collaborative management using telemonitoring improves quality of life and prevention of rehospitalization in patients with heart failure a pilot study. International heart journal. 2019;60(6):1293-302. [DOI:10.1536/ihj.19-313]
28. Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Statistical methods in medical research. 2016;25(3):1057-73. [DOI:10.1177/0962280215588241]
29. Browne RH. On the use of a pilot sample for sample size determination. Statistics in medicine. 1995;14(17):1933-40. [DOI:10.1002/sim.4780141709]
30. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics: The Journal of Applied Statistics in the Pharmaceutical Industry. 2005;4(4):287-91. [DOI:10.1002/pst.185]
31. Hosseinzadegan F, Azimzadeh R, Parizad N, Esmaeili R, Alinejad V, Hemmati Maslakpak M. Psychometric evaluation of the diabetes self-management questionnaire-revised form) Dsmq-R) in patients with diabetes. Nursing And Midwifery Journal. 2021;19(2):109-18.(in Persian)
32. Jafari A, Tehrani H, Mansourian M, Nejatian M, Gholian Aval M. Translation and localization the Persian version of diabetes distress scale among type 2 diabetes. Diabetology & Metabolic Syndrome. 2023;15(1):201. [DOI:10.1186/s13098-023-01173-z]
33. Ghanei Gheshlagh R, Ebadi A, Veisi Raygani AK, Nourozi Tabrizi K, Dalvandi A, Mahmoodi H. Determining concurrent validity of the Morisky medication adherence scale in patients with type 2 diabetes. Iranian Journal of Rehabilitation Research. 2015;1(3):24-32.(in Presian)
34. Powers MA, Bardsley JK, Cypress M, Funnell MM, Harms D, Hess-Fischl A, et al. Diabetes self-management education and support in adults with type 2 diabetes: a consensus report of the American Diabetes Association, the Association of Diabetes Care & Education Specialists, the Academy of Nutrition and Dietetics, the American Academy of Family Physicians, the American Academy of PAs, the American Association of Nurse Practitioners, and the American Pharmacists Association. Journal of the American Pharmacists Association. 2020;60(6):e1-8. [DOI:10.1016/j.japh.2020.04.018]
35. Ni Y, Liu S, Li J, Dong T, Tao L, Yuan L, et al. The Effects of Nurse‐Led Multidisciplinary Team Management on Glycosylated Hemoglobin, Quality of Life, Hospitalization, and Help‐Seeking Behavior of People with Diabetes Mellitus. Journal of Diabetes Research. 2019;2019(1):9325146. [DOI:10.1155/2019/9325146]
36. Steffen PL, Mendonça CS, Meyer E, Faustino-Silva DD. Motivational interviewing in the management of type 2 diabetes mellitus and arterial hypertension in primary health care: an RCT. American Journal of Preventive Medicine. 2021;60(5):e203-12. [DOI:10.1016/j.amepre.2020.12.015]
37. Soderlund PD. Effectiveness of motivational interviewing for improving physical activity self-management for adults with type 2 diabetes: A review. Chronic Illness. 2018;14(1):54-68. [DOI:10.1177/1742395317699449]
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