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Trial registered on ANZCTR


Registration number
ACTRN12615001249549
Ethics application status
Approved
Date submitted
11/11/2015
Date registered
16/11/2015
Date last updated
16/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of a self-management program on people with type 2 diabetes
Scientific title
Effectiveness of a self-management program on people with type 2 diabetes and their care giver in improving self-efficacy, quality of life and self-management in Thailand
Secondary ID [1] 287860 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 296741 0
Condition category
Condition code
Public Health 296979 296979 0 0
Health promotion/education
Metabolic and Endocrine 297000 297000 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293235 0
Behaviour
Intervention code [2] 293247 0
Treatment: Other
Comparator / control treatment
Control group participants will receive the standard usual care including routine follows up, physical examination and laboratory, general medical advice provided by physician, nurse educators and health care providers in the outpatient clinic during the 12 weeks of program. Individual diabetes education is provided for new cases as well as cases with uncontrolled blood glucose level however the program is unstructured with no lesson plan or theoretical foundation. At week 13 after commencement, the control group will receive the diabetes education intervention and the diabetes self-management booklet.
Control group
Active

Outcomes
Primary outcome [1] 296582 0
The primary outcome of the study will be diabetes self-management which is assessed by the performance of diabetes self-care behaviours over the past 7 days. It is measured by the Summary of Diabetes Self-Care Activities (SDSCA) .
Timepoint [1] 296582 0
5 weeks and 12 weeks post commencement of intervention
Secondary outcome [1] 318805 0
Diabetes management self-efficacy as measured by Diabetes Management Self-Efficacy Scale (DMSES). Diabetes Management Self-Efficacy Scale (DMSES) is a self-report questionnaire to measure self-efficacy of diabetes management in patients with type 2 diabetes.
Timepoint [1] 318805 0
5 weeks and 12 weeks post commencement of intervention
Secondary outcome [2] 318846 0
Quality of life as measured by the Short-Form 12-item (SF 12) health survey
Timepoint [2] 318846 0
5 weeks and 12 weeks post commencement of intervention
Secondary outcome [3] 318847 0
diabetes knowledge as measured by Diabetes Knowledge Questionnaire (DKQ-24)
Timepoint [3] 318847 0
5 weeks and 12 weeks post commencement of intervention
Secondary outcome [4] 318848 0
Carer diabetes management self-efficacy as measured by Carer Diabetes Management Self-Efficacy Scale (F-DMSES). It is a carers self-report questionnaire to measure self-efficacy of diabetes management in carers of patients with type 2 diabetes.
Timepoint [4] 318848 0
5 weeks and 12 weeks post commencement of intervention
Secondary outcome [5] 318849 0
Carers diabetes knowledge as measured by Diabetes Knowledge Questionnaire (DKQ-24).
Timepoint [5] 318849 0
5 weeks and 12 weeks post commencement of intervention
Secondary outcome [6] 318850 0
HbA1C levels as collected from the hospital records chart. The hospital is assessed using blood samples.
Timepoint [6] 318850 0
12 weeks post commencement of intervention

Eligibility
Key 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
Minimum age
35 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly assigned to the control (usual care) group and intervention (Diabetes self-management education plus usual care) groups, using a concealed envelope technique prepared independently of the researcher. The random allocation had been sealed on an envelope and retain by clinical staffs. Once, the participants have been consented to study and baseline data had been collected. The research assistant will open the sealed envelope indicating the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The researcher will use a computer-generated sequence of random numbers for random allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
An estimate of the sample size in this study will be calculated by using a sample size determinant formula for repeated measurement analysis with a level of significance of a = .05 (probability of type 1 error) and a power of 0.90 (1- probability of type 2 error). After calculation, the sample needed for this study would be 70 people per group.
Mean, standard deviation and percentage will be used to examine demographic and clinical data, diabetes knowledge, HbA1c, self-efficacy, self-management, quality of life, carers diabetes knowledge and family diabetes management self-efficacy of people with type 2 diabetes.
An independent t-test will be used to examine the difference in mean scores of diabetes knowledge, HbA1c, self-efficacy, self-management, quality of life, carers diabetes knowledge and family diabetes management self-efficacy of people with type 2 diabetes before and after entering the program for the two groups. The two way repeated measures analysis of variance (ANOVA) will be used to compare diabetes knowledge, HbA1c, self-efficacy, self-management, quality of life, carers diabetes knowledge and family diabetes management self-efficacy of people with type 2 diabetes across the two groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7322 0
Thailand
State/province [1] 7322 0
Suratthani

Funding & Sponsors
Funding source category [1] 292365 0
University
Name [1] 292365 0
Australian Catholic university
Address [1] 292365 0
1100 Nudgee road, Banyo, QLD 4014
Country [1] 292365 0
Australia
Primary sponsor type
University
Name
Australian Catholic university
Address
1100 Nudgee road, Banyo, QLD 4014
Country
Australia
Secondary sponsor category [1] 291048 0
None
Name [1] 291048 0
Address [1] 291048 0
Country [1] 291048 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293835 0
Human Research Ethics Committees of the Australian Catholic University
Ethics committee address [1] 293835 0
1100 Nudgee road, Banyo, QLD 4014
Ethics committee country [1] 293835 0
Australia
Date submitted for ethics approval [1] 293835 0
31/07/2014
Approval date [1] 293835 0
02/10/2014
Ethics approval number [1] 293835 0
2014 222Q

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61478 0
Miss Nutchanath Wichit
Address 61478 0
Australian Catholic University
1100 Nudgee road, Banyo, QLD 4014
Country 61478 0
Australia
Phone 61478 0
+61402616282
Fax 61478 0
Email 61478 0
nutchanath.wichit@myacu.edu.au
Contact person for public queries
Name 61479 0
Miss Nutchanath Wichit
Address 61479 0
Australian Catholic University
1100 Nudgee road, Banyo, QLD 4014
Country 61479 0
Australia
Phone 61479 0
+61402616282
Fax 61479 0
Email 61479 0
nutchanath.wichit@myacu.edu.au
Contact person for scientific queries
Name 61480 0
Miss Nutchanath Wichit
Address 61480 0
Australian Catholic University
1100 Nudgee road, Banyo, QLD 4014
Country 61480 0
Australia
Phone 61480 0
+61402616282
Fax 61480 0
Email 61480 0
nutchanath.wichit@myacu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary