The effects of individual and family self-management program on self-management behaviors, sleep quality, and inflammatory markers among adults with uncontrolled type 2 diabetes mellitus in Indonesia

Phase 3

• Conditions: Type 2 diabetes mellitus (T2DM) is a group of chronic metabolic disorders distinguished by abnormal insulin sensitivity and increased blood glucose concentration. Low levels of self-management behaviors, poor sleep quality, and high levels of inflammatory markers are important factors for detecting developing complications.; Diabetes type 2; Inflammation markers; Individual and family self-management; Self-management behaviors; Sleep quality

• Registration Number: TCTR20240321003
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-21
• Last Update Posted: 19 August 2024
• Study Completion: 2024-08-21

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Eligible participants will be recruited based on the following inclusion criteria: adults with uncontrolled T2DM with HbA1c greater than 7 percent, age 30 to 60 years, be able to communicate both verbally and in writing, be willing to participate, have a smartphone with internet access, and have family members living with them
Meanwhile, the inclusion criteria for the family members include: living in the same residence and having regular contact with the patient; age 30 to 60 years; being a spouse, child, grandchild, sibling, or other close relative (the family members will be chosen by patients); having a smartphone with internet access; and being willing to provide informed consent.

Exclusion Criteria

(1) were pregnant; (2) had previous cancer or thrombotic autoimmune diseases; (3) had a disability, auditory deficiencies, or dementia; (4) previously received self-management intervention.

Study & Design

• Study Type: Interventional
• Study Design: Not specified