THE EFFECTS OF INDIVIDUAL AND FAMILY SELF-MANAGEMENT PROGRAM ON GLYCATED HEMOGLOBIN AND HEALTH-RELATED QUALITY OF LIFE AMONG ADULTS WITH UNCONTROLLED TYPE 2 DIABETES MELLITUS IN INDONESIA

Tahapan Penelitian : Recruit
Sponsor:
Mitra Pelaksana:
No
No Registry
INA-OOR8AXF
Tanggal Input Registry : 27-12-2023

03-12-2023
The main outcomes of this study consist of: 1. Glycated Hemoglobin (HbA1c) 2. Health related quality of Life (HRQoL)
 
THE EFFECTS OF INDIVIDUAL AND FAMILY SELF-MANAGEMENT PROGRAM ON GLYCATED HEMOGLOBIN AND HEALTH-RELATED QUALITY OF LIFE AMONG ADULTS WITH UNCONTROLLED TYPE 2 DIABETES MELLITUS IN INDONESIA
THE EFFECTS OF INDIVIDUAL AND FAMILY SELF-MANAGEMENT PROGRAM ON GLYCATED HEMOGLOBIN AND HEALTH-RELATED QUALITY OF LIFE AMONG ADULTS WITH UNCONTROLLED TYPE 2 DIABETES MELLITUS IN INDONESIA
Interventional
The IFSM program will be administered to a cohort consisting of around 15-17 dyads, comprised of persons with suboptimal glycemic control and their respective family members. Consequently, the intervention group will be partitioned into two smaller subgroups. The researchers will invite the experimental participants to join the activities which consist of several activities, as follows:. 1. First (1st) Week: Face-to-Face Program (Friday and Saturday). Activities 1: Diabetes knowledge training. A 90-minute structured group education training that aims to improve the understanding of factual information about T2DM and self-management behaviors and their rationales will be conducted in the first week. The primary Investigator (PI) and co-investigators (Co-PI) will provide the education session, and module 01 will be given to the participants. The series of activities are, as follows; 1) The researchers build trusted relationships by implementing building learning commitment (BLC) through an introduction, ice-breaking, creating daily session objectives and expectations, and then posting on the blackboard in the class (5 minutes); 2) Providing short quizzes to determine their basic knowledge; (5 minutes); 3) Providing diabetes information: definition, diagnosis, signs and symptoms, complications with interesting images and a diabetes video presentation; (35 minutes); 4) The PI provides information about self-management behaviors and their rationale b: physical exercises, Diabetes Diet, Diabetes medication, and blood glucose monitoring by using Canva presentation design and infographics; (40 minutes); 5) The participants will be helped to evaluate their daily objectives by playing diabetes word games with answers (5 minutes). Activities 2: Self-Efficacy training. This session aims to enhance people with uncontrolled T2DM and their family’s belief or confidence to engage and maintain self-management behaviours to achieve glycemic control and improve the HRQoL. It will last 30 minutes and include the following activities; 1) Sharing and reflecting on the uncontrolled T2DM and their families’ beliefs about diabetes and DSM practices; 2) The researchers guide the discussion to change negative perceptions of diabetes and reinforce positive comments; 3) Sharing successful experiences from diabetic patients who experience the benefits of self-management behaviors and maintain their glycemic control. 2. Second (2nd) week: Self-regulation Training (Saturday) This third session will be carried out in 120-minute meetings in the second week (Friday). This session is designed to achieve change in diabetes self-management behaviours of people with uncontrolled T2DM and their families by practicing self-regulation skills and abilities. Therefore, to achieve these goals, the activities will be; 1) The researchers assist those with uncontrolled T2DM and their families in developing personal and family goals for self-management of diabetes (10 minutes); 2) The PI guide for reflective thinking to identify the possible barriers and challenges of DSM (5 minutes); 3) The researchers present a weekly meal planning form and direct individuals with uncontrolled T2DM and their families to create calorie-based meal plans for their diabetes (25 minutes); 4) The researchers present the weekly exercise planning form and instruct individuals with uncontrolled type 2 diabetes (T2DM) and their families on how to create their weekly activity planners (150 minutes of walking per week or 30 minutes per day). (15 minutes); 5) The researchers explain the planning form for self-monitoring blood sugar levels and assist persons with uncontrolled T2DM and their families in creating their planner (5 minutes); 6) The researchers explain the diabetes medication diary and assist persons with uncontrolled T2DM and their families in creating planners (5 Minutes); 7) The researchers give the families instructions on how to use and fill out the Diabetes Self-Management Monitoring Checklist (5 minutes); and 8) Talk about the family's responsibilities in SMB, such as taking patients to appointments, preparing food, rescheduling time for meals, complying with many kinds of medicine, and emotional support to cope with the long-term follow-up care of diabetes helping patients, and initiating change in exercise (10 minutes) 3. Week 3, 5, 7, and 9: Family phone calls (every Tuesday) This program aims to promote family discussion and provide ongoing encouragement for SMB performance. The PI and co-PI will make 15-20-minute phone calls to the families in weeks 3, 5, 7, 9, and 11. Week 3: Set up a situation that is convenient for phone calls, listen attentively, and carefully assess each person's weekly meal plan, weekly exercise schedule, diabetes medications, and blood sugar monitoring on week 3. Do they adhere to the strategy? amplify any form of accomplishment. Additionally, the phone conversations highlight any obstacles or hurdles to implementing the DSM weekly plan and serve as a motivator and reminder of the diabetes SMB's key message (table 01). Week 5: Evaluate their adherence to meals, exercise, blood glucose monitoring, and diabetes pills weekly plan on weeks 03 and 04. Discuss the challenges or progress, provide motivation, and remind the key message of diabetes SMB (diet, Physical exercise, Medication adherence, Blood glucose monitoring) (table 01). Week 7: Evaluate their adherence to meals, exercise, blood glucose monitoring, and diabetes pills weekly plan on weeks 05 and 06. Discuss the challenges or progress and provide motivation and remind the key message of diabetes SMB (diet, Physical exercise, Medication adherence, Blood glucose monitoring) (table 01). Week 9: Evaluate their adherence to meals, exercise, blood glucose monitoring, and diabetes pills weekly plan on weeks 07 and 08. Discuss the challenges or progress and provide motivation and remind the key message of diabetes SMB (diet, Physical exercise, medication adherence, blood glucose monitoring) (table 01). Week 11: Evaluate their adherence to meals, exercise, blood glucose monitoring, and diabetes pills weekly plan on weeks 07 and 08. Discuss the challenges or progress and provide motivation and remind the key message of diabetes SMB (diet, Physical exercise, medication adherence, blood glucose monitoring) (table 01). Moreover, the assessment of diabetes self-management behaviors acquired by the participant from all these weeks by checking their weekly or monthly plan of DSM. 4. Week 4, 6, 8, 10, and 12; Delivering the SMB infographics (Monday, Wednesday, and Friday) Several SMB infographics and motivational messages will be delivered every Monday, Wednesday, and Friday which aim to motivate and remind them to keep performing the SMB (Appendix B). The SMB infographic will be sent at around 12-1 PM and will be checked at around 6 PM. Reminder messages to read the cards will be sent at around 6.30 PM. The diabetes infographics that will be delivered to WA groups involve diabetes medication, physical exercise: healthy eating, blood sugar monitoring, and family roles.
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Inclusion Criteria:

Sample selection will be based on the sample size frame. Eligible participants will be recruited by the following inclusion criteria: 1.adults with uncontrolled T2DM (HbA1c ≥7 %), 2.age 40-65 years (highest prevalence of T2DM), 3.have already living with diabetes for less than 10 years 4.use oral antidiabetics (OAD), 5.be able to communicate (both verbal and written); 6.agree to undergo the whole process of the IFSM program; 7.have a smartphone with internet access, 8.not enroll in another research program and have family members living with them. The discontinuation criteria include hospital admissions due to acute complications or surgery. Meanwhile, the inclusion criteria for the family members include; 1.living in the same residence and having contact with the patient regularly, 2.Being a spouse or child who actively participates in the IFSM program and plays a crucial role in assisting its implementation within the home setting (the family members will be nominated by patients); 3.being willing to provide informed consent. 4.aged 18 years or older

Exclusion Criteria:

The exclusion criteria consist of the following criteria: 1. those who previously participated in diabetes intervention, and 2. patients with diabetes-related severe complications.
 
LB.02.03/1/0202/2023
Not applicable
Not applicable
Margareta Teli, SKep,Ns, MSc-PH, PhD (c)