Therapeutic Adherence in Type 2 Diabetes

NCT07837856 | Completed DMC

• 1 other identifier: R-2024-1602-063
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

A quasi-experimental, non-randomized, prospective, longitudinal study comparing the use of WhatsApp messaging versus the SMART technique in patients with type 2 diabetes to improve treatment adherence

Conditions

Diabetes Mellitus, Type 2/Prevention & Control; Diabete Type 2; Treatment Adherence

Keywords

treatment adherence, polypharmacy, SMART goals, glycemic control.; Treatment adherence; polypharmacy; glucose

Outcome Measures

Primary Outcomes (1)

• Therapeutic adherence

  According to the Morisky-Green questionnaire: Good \>8 points, Fair 6-7 points, Poor \<6 points

  Assessments were conducted at the start of the study "Baseline" (November to December 2024) and "6 months" after the intervention (May to June 2025)

Secondary Outcomes (2)

• multipharmacy

  Evaluations were conducted at the start of the study "Baseline" (November to December 2024).

• Glucose

  Assessments were conducted at the start of the study "Baseline" (November to December 2024) and "6 months" after the intervention (May to June 2025).

Other Outcomes (4)

• Cholesterol

  Assessments were conducted at the start of the study "Baseline" (November to December 2024) and "6 months" after the intervention (May to June 2025).

• Triglycerides

  Assessments were conducted at the start of the study "Baseline" (November to December 2024) and "6 months" after the intervention (May to June 2025).

• Body Mass Index:

  Assessments were conducted at the start of the study "Baseline" (November to December 2024) and "6 months" after the intervention (May to June 2025).

Study Arms (2)

Group I received WhatsApp messages

EXPERIMENTAL

Group I: Participants received behavioral training and education on T2D, treatment adherence, and polypharmacy, along with the messages shown below via WhatsApp. Positive reinforcement messages were sent once every two days for two weeks, followed by one per week for three weeks.

Other: Group I (WhatsApp) motivational and educational messages delivered periodically

Group II underwent the SMART S(Specific), M(Measurable, A(Achievable), R(Relevant), T(Timetechnique

ACTIVE COMPARATOR

Group II: To implement the SMART method, the patient was first given an explanation of the concept of a goal or objective, as well as what each of the concepts of the SMART method entails. The participant was then asked to identify a goal that meets the SMART criteria and, above all, is measurable.

Other: Group II: To implement the SMART method

Interventions

Group I (WhatsApp) motivational and educational messages delivered periodically OTHER

Positive reinforcement messages were sent once every two days for two weeks, then once a week for three weeks

Group I received WhatsApp messages

Group II: To implement the SMART method OTHER

Group II: To implement the SMART method, the patient was first given an explanation of the concept of a goal or objective, as well as what each of the concepts of the SMART method entails. The participant was then asked to identify a goal that meets the SMART criteria and, above all, is measurable.

Group II underwent the SMART S(Specific), M(Measurable, A(Achievable), R(Relevant), T(Timetechnique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 2 diabetes mellitus.
• Patients enrolled in UMF 84.
• Men and women between the ages of 35 and 70.
• Patients who agree to participate, understand the informed consent form, and sign it.
• Patients who have a cell phone and the WhatsApp app.

You may not qualify if:

• Patients with type 1 diabetes mellitus.
• Patients with dementia, schizophrenia, alcoholism, drug addiction, cancer, Parkinson's disease, hearing and vision impairments, and comprehension and language disorders.
• Pregnant patients.
• Patients who cannot read or write.
• Patients who withdraw their consent.
• Patients who fail to attend laboratory tests, questionnaire administration, or regular medical appointments.
• Patient death.
• Changes in health insurance enrollment.
• Loss of health insurance coverage.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Family Medicine Unit No. 84

Morelia, Michoacán, 58332, Mexico

Location

Related Publications (15)

• Buntyn RW, Burtson KM, Grey K, Cox R, Nehzati A, Silverman ML, Mrozek RA, Wilson KR. Diabetes Self-Management Goals in an Internal Medicine Clinic: A Quality Improvement Initiative. Mil Med. 2026 May 1;191(5-6):e1327-e1332. doi: 10.1093/milmed/usaf407.

  PMID: 40829048 BACKGROUND

• de Hoogh IM, Winters BL, Nieman KM, Bijlsma S, Krone T, van den Broek TJ, Anderson BD, Caspers MPM, Anthony JC, Wopereis S. A Novel Personalized Systems Nutrition Program Improves Dietary Patterns, Lifestyle Behaviors and Health-Related Outcomes: Results from the Habit Study. Nutrients. 2021 May 22;13(6):1763. doi: 10.3390/nu13061763.

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• Saluja M, Pillai D. Exercise Prescription in Diabetes- S.M.A.R.T.: A Prospective Study. J Assoc Physicians India. 2021 Feb;69(2):22-24.

  PMID: 33527806 BACKGROUND

• Cook HE, Garris LA, Gulum AH, Steber CJ. Impact of SMART Goals on Diabetes Management in a Pharmacist-Led Telehealth Clinic. J Pharm Pract. 2024 Feb;37(1):54-59. doi: 10.1177/08971900221125021. Epub 2022 Sep 2.

  PMID: 36052449 BACKGROUND

• Kalyani RR, Neumiller JJ, Maruthur NM, Wexler DJ. Diagnosis and Treatment of Type 2 Diabetes in Adults: A Review. JAMA. 2025 Sep 16;334(11):984-1002. doi: 10.1001/jama.2025.5956.

  PMID: 40549398 BACKGROUND

• Alshalani A, AlAhmari N, Amin HA, Aljedai A, AlSudais H. Biochemical Profile Variations Among Type 2 Diabetic Patients Stratified by Hemoglobin A1c Levels in a Saudi Cohort: A Retrospective Study. J Clin Med. 2025 Jul 28;14(15):5324. doi: 10.3390/jcm14155324.

  PMID: 40806947 BACKGROUND

• Bi Y, Li M, Liu Y, Li T, Lu J, Duan P, Xu F, Dong Q, Wang A, Wang T, Zheng R, Chen Y, Xu M, Wang X, Zhang X, Niu Y, Kang Z, Lu C, Wang J, Qiu X, Wang A, Wu S, Niu J, Wang J, Zhao Z, Pan H, Yang X, Niu X, Pang S, Zhang X, Dai Y, Wan Q, Chen S, Zheng Q, Dai S, Deng J, Liu L, Wang G, Zhu H, Tang W, Liu H, Guo Z, Ning G, He J, Xu Y, Wang W; BPROAD Research Group. Intensive Blood-Pressure Control in Patients with Type 2 Diabetes. N Engl J Med. 2025 Mar 27;392(12):1155-1167. doi: 10.1056/NEJMoa2412006. Epub 2024 Nov 16.

  PMID: 39555827 BACKGROUND

• Na-Ek N, Srithong J, Aonkhum A, Boonsom S, Charoen P, Demakakos P. Educational level as a cause of type 2 diabetes mellitus: Caution from triangulation of observational and genetic evidence. Acta Diabetol. 2022 Jan;59(1):127-135. doi: 10.1007/s00592-021-01795-7. Epub 2021 Sep 12.

  PMID: 34514530 BACKGROUND

• Rognstad S, Brekke M, Fetveit A, Spigset O, Wyller TB, Straand J. The Norwegian General Practice (NORGEP) criteria for assessing potentially inappropriate prescriptions to elderly patients. A modified Delphi study. Scand J Prim Health Care. 2009;27(3):153-9. doi: 10.1080/02813430902992215.

  PMID: 19462339 BACKGROUND

• Remelli F, Ceresini MG, Trevisan C, Noale M, Volpato S. Prevalence and impact of polypharmacy in older patients with type 2 diabetes. Aging Clin Exp Res. 2022 Sep;34(9):1969-1983. doi: 10.1007/s40520-022-02165-1. Epub 2022 Jun 20.

  PMID: 35723858 BACKGROUND

• Lorig KR, Holman H. Self-management education: history, definition, outcomes, and mechanisms. Ann Behav Med. 2003 Aug;26(1):1-7. doi: 10.1207/S15324796ABM2601_01.

  PMID: 12867348 BACKGROUND

• Hayakawa M, Uchimura Y, Omae K, Waki K, Fujita H, Ohe K. A smartphone-based medication self-management system with realtime medication monitoring. Appl Clin Inform. 2013 Jan 30;4(1):37-52. doi: 10.4338/ACI-2012-10-RA-0045. Print 2013.

  PMID: 23650486 BACKGROUND

• Vermeire E, Hearnshaw H, Van Royen P, Denekens J. Patient adherence to treatment: three decades of research. A comprehensive review. J Clin Pharm Ther. 2001 Oct;26(5):331-42. doi: 10.1046/j.1365-2710.2001.00363.x.

  PMID: 11679023 BACKGROUND

• Burnier M, Egan BM. Adherence in Hypertension. Circ Res. 2019 Mar 29;124(7):1124-1140. doi: 10.1161/CIRCRESAHA.118.313220.

  PMID: 30920917 BACKGROUND

• Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022 Jan;183:109119. doi: 10.1016/j.diabres.2021.109119. Epub 2021 Dec 6.

  PMID: 34879977 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Health Behavior; Behavior

Study Officials

• María del Pilar P Rodriguez-Correa, Master Degree

  Mexican Social Security Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Master of Science in Health Sciences

Model Details: A prospective, longitudinal, a quasi-experimental study, included patients aged 35 to 70 years, with a diagnosis of T2D, were included. Exclusion criteria were oncological disease, psychiatric disorders, and communication limitations. Two groups, each with 52 patients, were included; all patients received training on general concepts related to type 2 diabetes, medical treatment, and healthy lifestyles. They were then divided into two groups: Group I received WhatsApp messages, and Group II underwent the SMART technique to improve treatment adherence.

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 24, 2026
• Study Start: November 30, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)