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

NCT05491252 | Completed DMC

• 1 other identifier: 335-21
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 4

Brief 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

Type 2 Diabetes

Keywords

Type 2 Diabetes, Self-management, Patient Centred Care, RCT

Outcome Measures

Primary Outcomes (1)

• Change in Glycemic Control (HbA1c)

  HbA1c will be measured by collecting venous plasma samples and sending them to the single central laboratory to assure consistency and uniformity in methodology. The samples will be drawn by Data Collectors/Outcome Assessors and laboratory measurements will be performed by a trained laboratory technician.

  HbA1c will be measured at three points in time (1) at baseline, (2) at completion of 8 weeks intervention, and (3) at three months follow-up

Secondary Outcomes (2)

• Self Efficacy

  Self Efficacy will be measured at three points in time (1) at baseline, (2) at completion of 8 weeks intervention, and (3) at three months follow-up

• Self Care Behaviors

  Self care behaviors will be measured at three points in time (1) at baseline, (2) at completion of 8 weeks intervention, and (3) at three months follow-up

Study Arms (2)

Control Group (CG)

NO INTERVENTION

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

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).

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

Interventions

PAtient CEntered Self-Management Intervention (PACE-SMI) BEHAVIORAL

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.

Intervention Group (IG)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Type 2 DM Patient with HbA1c \< 7
• Uncontrolled psychological comorbidity (psychosis, schizophrenia, dementia or severe learning difficulties).
• 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).
• Life expectancy of less than six months as determined by patient's primary physician.
• Living outside of Faisalabad City.

Sponsors & Collaborators

• Shifa Tameer-e-Millat University: lead

Study Sites (4)

District Head Quarter (DHQ) Hospital

Faisalabad, Punjab Province, 38000, Pakistan

Location

Allied Hospital

Faisalābad, Punjab Province, 38000, Pakistan

Location

Government General Hospital

Faisalābad, Punjab Province, 38000, Pakistan

Location

Punjab Social Security Hospital

Faisalābad, Punjab Province, 38000, Pakistan

Location

Related Publications (1)

• Asmat K, Dhamani K, Froelicher ES, Gul R. A Patient-Centered Self-Management Intervention to Improve Glycemic Control, Self-Efficacy and Self-Care Behaviors in Adults with Type 2 Diabetes Mellitus: A SPIRIT Compliant Study Protocol for Randomized Controlled Trial. Diabetes Metab Syndr Obes. 2023 Jan 26;16:225-236. doi: 10.2147/DMSO.S385715. eCollection 2023.

  PMID: 36760576 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Khairunnisa Dhamani, PhD

  Shifa Tameer e Millat University, Islamabad, Pakistan

  STUDY DIRECTOR

• Erika Froelicher, PhD

  Shifa Tameer-e-Millat University

  STUDY DIRECTOR

• Raisa Gul, PhD

  Shifa Tameer-e-Millat University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data Collectors / Outcome Assessors will be blinded of which treatment group subject is assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kainat Asmat

Model Details: In parallel arm design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention. After randomization each subject stays in their assigned treatment arm for the duration of the study. Subjects receive the same treatment throughout the trial. The results are then compared.

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: April 21, 2022
• Primary Completion: February 7, 2023
• Study Completion: February 17, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (4)