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

University of Turku

Status: Suspended

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Routine care; Behavioral: Self-management education

Study type: Interventional

Funder types: Other

Identifiers

NCT02594748

BK2014011

Details and patient eligibility

About

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).

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Behavioral: Self-management education

Comparison group

Active Comparator group

Description:

The comparison group will receive routine care

Treatment:

Behavioral: Routine care