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

University of Turku1 site in 1 country280 target enrollmentJuly 2015

ConditionsDiabetes Mellitus, Type 2

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 2
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.
Status: Suspended
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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:
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.

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

December 2019

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Turku

Responsible Party

Principal Investigator

FangFang Zhao

PhD student

University of Turku

Eligibility Criteria

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.

Exclusion Criteria

Not provided

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 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.)
Change from baseline in Blood sugar at 3-month follow up.(Baseline,3-month follow up.)