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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240321003
Enrollment
68
Registered
2024-03-21
Start date
2024-03-18
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

The IFMS intervention program provided education of knowledge and belief, self-efficacy improvement, self-regulation skill improvement and social facilitation improvement in the process dimension. The
the telephone for follow-up (15 to 20 minutes) at each Tuesday per week to monitor the program
and the motivational card message every Monday, Wednesday, and Friday per week. The program will be consisted of (1) the 2 education sessions delivered at week 1 and week 2 at each Saturday (200 minut
(2) the telephone for follow-up (15-20 minutes) at each Tuesday per weeks to monitoring program and (3) the motivational card message every Monday, Wednesday, and Friday per weeks. The education sess
12 text m
Experimental Behavioral,No Intervention No treatment
Individual and family self management Program,Control group

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
30 Years to 60 Years

Inclusion criteria

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

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Diabetes Self-management before and after intervention Diabetes Self-management Score,The clinical and biochemical measures before and after intervention FBG and Triglyceride-Glucose Index (TyG)

Secondary

MeasureTime frame
Sleep quality before and after intervention The Pittsburgh Sleep Quality Index (PSQI,Family suport before and after intervention Diabetes Family Behavior Checklist,Diabetes Distress before and after intervention Diabetes Distress Scale (DDS),The clinical and biochemical measures before and after intervention Neutrophil-lymphocyte ratio (NLR), platelets-lymphocyte ratio (PLR), and the systemic immune-inflammation index (SII).

Countries

Indonesia

Contacts

Public ContactYohanes Rias

Chulalongkorn University and Institut Ilmu Kesehatan Bhakti Wiyata Kediri

yohanes.andi@iik.ac.id085707388190

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026