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A Randomized Controlled Trial of Patient-Centered Self-Management Intervention in Adults With Type 2 Diabetes Mellitus

NCT05491252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 612

Last updated 2023-04-11

No results posted yet for this study

Summary

Type 2 Diabetes Mellitus (DM) is a serious health problem for Pakistan and around the world due to its increasing prevalence and the risk of adverse health outcomes including kidney failure, heart attack, stroke, leg amputation and blindness. These problems reduce the quality of life of individuals with type 2 DM and increase their financial burden, thereby affecting the national economy. Given its huge health and economic impact, preventing type 2 DM progression and reducing the risk of associated complications requires immediate attention. Evidence suggests that self-management can slow the progression of type 2 DM, minimizes the risk of major complications and hence, lowers health-care costs. The purpose of this study is to test the effectiveness of a patient centered self-management intervention to improve health outcomes in adults with type 2 DM. It is expected that patients receiving this intervention would have improved health outcomes as compared to patients who did not.

Conditions

Interventions

BEHAVIORAL

PAtient CEntered Self-Management Intervention (PACE-SMI)

Week 1: General disease knowledge. Week 2: Role of self-care behaviors towards effective management of type 2 diabetes, motivational video and real story of a diabetic patient to serve as a role-model. Lastly, provision of diabetes self-care guidebook. Week 3: Home visit to observe facilitators and barriers on initiating and maintaining behavioral change with social support as a key strategy. Week 4: ECB session on Diet. Week 5: ECB session on Physical Activity. Week 6: ECB session on Foot Care. Week 7: ECB session on Medication Adherence. Week 8: Booster session comprising reflection, performance feedback and review of behavioral goals fostering continued performance accomplishment and addressing difficulties of maintaining behaviour change over time.

Sponsors & Collaborators

  • Shifa Tameer-e-Millat University

    lead OTHER

Principal Investigators

  • Khairunnisa Dhamani, PhD · Shifa Tameer e Millat University, Islamabad, Pakistan

  • Erika Froelicher, PhD · Shifa Tameer-e-Millat University

  • Raisa Gul, PhD · Shifa Tameer-e-Millat University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2023-02-07
Completion
2023-02-17

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05491252 on ClinicalTrials.gov