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

Shifa Tameer-e-Millat University

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: PAtient CEntered Self-Management Intervention (PACE-SMI)

Study type: Interventional

Funder types: Other

Identifiers

NCT05491252

335-21

Details and patient eligibility

About

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.

Full description

Background: In Pakistan, the rising burden of type 2 Diabetes Mellitus (DM) and its associated complications is considerably affecting the functional capacity of the individuals, their quality of life and demand for healthcare services with significant economic impact on health care system and the national economy. Given its enormous 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 and minimize the risk of major complications thereby lowering health-care costs. Efective self-management on the other hand, demands patients' confidence and their full commitment to perform self care tasks necessitating a patient-centered approach.

Objective: To test the efficacy of a patient centered self-management intervention to improve glycemic control, self-efficacy and self-care behaviors in adults with type 2 DM.

Setting, Duration, Study Type: The study will be carried out as a randomized controlled trial (RCT) in four public tertiary care hospitals in Faisalabad, Pakistan.

Methods: A total 612 subjects will be recruited from out-patient departments (OPDs) of the study hospitals. Using random allocation 306 subjects will be assigned to the control group and 306 to the intervention group. Both the control group and the intervention group will receive usual care delivered at study hospitals. The intervention group will additionally receive a patient centered self-management Intervention for eight weeks duration.

Expected Outcome: If the study is able to show that the intervention group had improved glycemic control, self-efficacy and self-care behaviors than the control group. Then, employing hospital policies, this evidence-based care may be provided to all DM patients.

Enrollment: 612 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult (aged 18 years or above)
2. Diagnosed with type 2 Diabetes Mellitus for at least 06 months duration.
3. Willing to participate in the study by signing of the consent form.

Exclusion criteria

1. Type 2 DM Patient with HbA1c < 7
2. Uncontrolled psychological comorbidity (psychosis, schizophrenia, dementia or severe learning difficulties).
3. Severe comorbidity that may limit participation (medical conditions such as cancer, stroke with disabilities, or need for regular dialysis etc. that preclude complete participation in this study).
4. Life expectancy of less than six months as determined by patient's primary physician.
5. Living outside of Faisalabad City.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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612 participants in 2 patient groups

Control Group (CG)

No Intervention group

Description:

The subjects in the Control Group (CG) will receive usual care as being received in study hospitals. Usual care at study hospitals involve consultaion with the physician which encompasses history taking, blood glucose measurement, prescription and provision of general education regarding lifestyle modification verbally or in the form of pamphelets.

Intervention Group (IG)

Experimental group

Description:

The subjects in the Intervention Group (IG) will receive usual care as well as a nurse-led PAtient CEntered Self-Management Intervention (PACE-SMI). PACE-SMI will be delivered for eight weeks duration comprising eight face to face individual and group educational, couselling and behavioral (ECB) training sessions in addition to telephonic reminders and a home visit by Principal Investigator (PI) and Research Assistants (RA). Outcome variables will be measured at three points in time (at baseline, at completion of intervention and lastly, after three months follow-up).

Treatment:

Behavioral: PAtient CEntered Self-Management Intervention (PACE-SMI)