None listed
Conditions
Brief summary
The aim of this study is to develop a family-supported self-management program for people with T2DM and examine the effects of the program on diabetes knowledge, diabetes self-efficacy, self-management, HbA1c level, quality of life, and carer diabetes management self-efficacy in Thai people with diabetes mellitus. We hypothesise that i) self-efficacy, self-management, quality of life, carer diabetes management self-efficacy, diabetes knowledge of Thai people with T2DM and their carers in intervention group is increasing after entering the intervention while HbA1c is decreasing; ii) self-efficacy, self-management, quality of life, carer diabetes management self-efficacy, and diabetes knowledge of Thai people with T2DM in intervention arm is greater than control arm at the end of intervention while HbA1c in intervention group is lower than control group. This is a prospective single-blind randomised controlled trial (RCT) of self-management programme and standard usual care for T2DM patients from Thailand A baseline and follow up assessment will be undertaken at 5 and 12 weeks. Ethic approval has been obtained from the Human Research Ethics Committees of the Australian Catholic University and Thachang Hospital. Informed consent will be obtained from all participants and their carer. The trial will be conducted and defined in accordance to CONSORT (Consolidated Standards of Reporting Trials) guidelines. The setting will be diabetes clinics in Thachang hospital and patients' homes in Thachang district at Suratthani Province, Thailand. This is the community hospital which 30 in-patient beds. These clinics were purposively selected on the basis that they are representative of T2DM patients and care in the rural community.
Interventions
12 weeks of intervention will be provided to participants and their carers in intervention group. Three sessions (1 hour/ session) of small group diabetes educations and three sessions of small group discussions (1 hour/ session) will be provided by the researcher in the 1st, 5th and 9th week. People with type 2 diabetes and their carers will receive diabetes education classes, group discussions and the diabetes self–management booklet at the diabetes clinic. Diabetes education session one, grou
12 weeks of intervention will be provided to participants and their carers in intervention group. Three sessions (1 hour/ session) of small group diabetes educations and three sessions of small group discussions (1 hour/ session) will be provided by the researcher in the 1st, 5th and 9th week. People with type 2 diabetes and their carers will receive diabetes education classes, group discussions and the diabetes self–management booklet at the diabetes clinic. Diabetes education session one, group discussion one and the first booklet will be given to the participants and their carers at enrolment that it contains a general diabetes knowledge including the meaning, type, signs and symptoms, complication and blood glucose testing. This session will take approximately 1 hour for the education class and then 1 hour for the group discussion, demonstration and return demonstration for self-testing of blood sugar. Session two of diabetes education, group discussion two, and the second booklet will be provided in week 5. This session is about diabetes diet for 1 hour and then 1 hour for the group discussion and the creation of a meal plan. The third session of diabetes education, third group discussion and third booklet are about physical activities and foot care and will be provided to participant in week 9. The diabetes education session will take 1 hour and then 1 hour for the group discussion, foot exercise and strengthening muscle activities. In conclusion, in week 1, 5, and 9 small group diabetes education will be provided to participants and their carers together for 1 hour and then and 1 hour for group discussion and demonstration. Participants and their carers need to register of attendance before participating in each session. The researcher provides an individual session (home visiting at the 3rd week) of approximately 30 min/session. This session will promote problem solving, anticipation of barriers and maintenance new behaviour, continuing education, ongoing reinforcement and making adjustments for goal attainment. 10-15 minutes telephone follows up will be provided to participants at the 7th week for persuasion and maintenance of appropriate activities.
Sponsors
Australian Catholic university
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria will be people with type 2 diabetes who 1) are aged 35 years or over with a diagnosis of type 2 diabetes for at least 6 months; 2) have a fasting plasma glucose more than 140 mg/dl for at least 2 follow up visits at the clinic; 3) able to communicate, read and write the Thai language; 4) are willing to have the researcher visit their home; 5) have a telephone contact at their residence; 6) have a carer who lives with them and 7) are willing to participate in the study
Exclusion criteria
Exclusion criteria include people with type 2 diabetes who 1) have severe complications and unable to participate in the program (e.g. retinopathy, stroke); 2) are being treated by insulin therapy; and 3) who leave the District.
Outcome results
None listed