Diabetes Mellitus, Type 2
Conditions
Brief summary
The aims of the study are as follows: * To improve self-management intention and behavior of patients with type 2 diabetes (T2 DM). * To promote patients to make plans for their self-management and gradually integrate the self-management plan into their daily life. * To improve resilience, well-being, fatigue and quality of life of patients with T2 DM In order to achieve the aims, we have set the following objectives: * To develop and apply self-management education program based on the extended theory of planned behavior. * To evaluate the efficacy of the educational program: 1. Self-management education program delivered face to face (intervention group); (b) standard usual care (comparison group).
Detailed description
This study employs a quasi-experimental study design with an intervention and comparison group and follow-up of 3 months; there will be two measuring points (baseline and 3 months after the intervention) , and 9 measures.
Interventions
BEHAVIORALSelf-management education
The intervention group will receive diabetes self-management education based on the idea of extended theory of planned behavior .
BEHAVIORALRoutine care
They will attend the routine lecture in hospital sit and listen, usually 1-2 times during one week in hospital
Sponsors
University of Turku
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
1. age ≥18 years 2. duration of type 2 diabetes ≥3 months 3. without any severe complication and impaired cognition.
Exclusion criteria
are: 1. severe physical handicap or mental illness 2. presence of other serious disease such as cancer and stroke.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Audit of Diabetes Dependent Quality of Life at 3-month follow up. | baseline and at three months. | Measure the impact and important of 19 life domains. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Well-Being Index (WHO-5) | Baseline,3-month follow up. | — |
| Change from baseline in The Summary of Diabetes Self-Care Activities Measure at 3-month follow up. | Baseline,3-month follow up. | The scale include diet, exercise, medication, foot care and blood sugar monitoring |
| Change from baseline in self-management planned behavior developed according to guideline at 3-month follow up. | Baseline,3-month follow up. | It is based on theory of planned behavior according to the following guideline. Including attitude, subjective norm, perceived behavior control, intention and behavior, action planning and coping planning.The response used likert 1-7 format. |
| Change from baseline in Fatigue-14 scale at 3-month follow up. | Baseline,3-month follow up. | — |
| Change from baseline in HbA1c at 3-month follow up. | Baseline, 3-month follow up. | HbA1c will be measured at outpatient of hospital. |
| Change from baseline in BMI at 3-month follow up. | Baseline,3-month follow up. | BMI will be measured at hospital and participants' home. |
| Change from baseline in Blood sugar at 3-month follow up. | Baseline,3-month follow up. | Blood sugar will be measured at hospital and participants' home. |
| Change from baseline in Connor-Davidson Resilience Scale-10 at 3-month follow up. | Baseline,3-month follow up. | — |
Countries
China
Outcome results
None listed