The Effects of Self-management Education Based on Theory of Planned Behavior on Patients With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: Self-management educationBehavioral: Routine care
- Registration Number
- NCT02594748
- Lead Sponsor
- University of Turku
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 280
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Self-management education 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. Comparison group Routine care The comparison group will receive routine care
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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. Baseline,3-month follow up. The scale include diet, exercise, medication, foot care and blood sugar monitoring
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. 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 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 Blood sugar at 3-month follow up. Baseline,3-month follow up. Blood sugar will be measured at hospital and participants' home.
Trial Locations
- Locations (1)
The First People Hospital, Affiliated hospital of Nantong University
🇨🇳Nantong, Jiangsu, China