The Effects of Self-management Education Based on Theory of Planned Behavior on Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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: Self-management education program delivered face to face (intervention group); (b) standard usual care (comparison group).

Detailed Description
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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.

Official Title
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The Effects of Self-management Education Based on Theory of Planned Behavior on Self-management and Quality of Life of Patients With Type 2 Diabetes and the Other Influencing Factors of Quality of Life

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Self-management education
* Behavioral: Routine care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥18 years duration of type 2 diabetes ≥3 months without any severe complication and impaired cognition. Exclusion criteria are: severe physical handicap or mental illness presence of other serious disease such as cancer and stroke.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Intervention is administered to patients in this Arm. The intervention is self-management education based on the theory of planned behavior(TPB). The intervention of experimental group is individual guide and face to face education based on TPB. | Behavioral: Self-management education<br>* The intervention group will receive diabetes self-management education based on the idea of extended theory of planned behavior .<br>|
| Active Comparator: Comparison group<br>The comparison group will receive routine care | Behavioral: Routine care<br>* They will attend the routine lecture in hospital sit and listen, usually 1-2 times during one week in hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Audit of Diabetes Dependent Quality of Life at 3-month follow up. | Measure the impact and important of 19 life domains. | baseline and at three months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Fatigue-14 scale at 3-month follow up. |  | Baseline,3-month follow up. | 
| 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. | The scale include diet, exercise, medication, foot care and blood sugar monitoring | Baseline,3-month follow up. | 
| Change from baseline in self-management planned behavior developed according to guideline at 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. | Baseline,3-month follow up. | 
| Change from baseline in Connor-Davidson Resilience Scale-10 at 3-month follow up. |  | Baseline,3-month follow up. | 
| Change from baseline in HbA1c at 3-month follow up. | HbA1c will be measured at outpatient of hospital. | Baseline, 3-month follow up. | 
| Change from baseline in BMI at 3-month follow up. | BMI will be measured at hospital and participants' home. | Baseline,3-month follow up. | 
| Change from baseline in Blood sugar at 3-month follow up. | Blood sugar will be measured at hospital and participants' home. | Baseline,3-month follow up. |