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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- University of Turku
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Change from baseline in Audit of Diabetes Dependent Quality of Life at 3-month follow up.
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age ≥18 years
- •duration of type 2 diabetes ≥3 months
- •without any severe complication and impaired cognition.
Exclusion Criteria
- •severe physical handicap or mental illness
- •presence of other serious disease such as cancer and stroke.
Arms & Interventions
Experimental group
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.
Intervention: Self-management education (Behavioral)
Comparison group
The comparison group will receive routine care
Intervention: Routine care (Behavioral)
Outcomes
Primary Outcomes
Change from baseline in Audit of Diabetes Dependent Quality of Life at 3-month follow up.
Time Frame: baseline and at three months.
Measure the impact and important of 19 life domains.
Secondary Outcomes
- Change from baseline in Blood sugar at 3-month follow up.(Baseline,3-month follow up.)
- 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.)
- 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.)
- Change from baseline in BMI at 3-month follow up.(Baseline,3-month follow up.)
- Change from baseline in self-management planned behavior developed according to guideline at 3-month follow up.(Baseline,3-month follow up.)
Investigators
FangFang Zhao
PhD student
University of Turku