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

NCT ID: NCT02594748

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-12-31

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:

1. 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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Self-management education

Intervention Type BEHAVIORAL

The intervention group will receive diabetes self-management education based on the idea of extended theory of planned behavior .

Comparison group

The comparison group will receive routine care

Group Type ACTIVE_COMPARATOR

Routine care

Intervention Type BEHAVIORAL

They will attend the routine lecture in hospital sit and listen, usually 1-2 times during one week in hospital

Interventions

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Self-management education

The intervention group will receive diabetes self-management education based on the idea of extended theory of planned behavior .

Intervention Type BEHAVIORAL

Routine care

They will attend the routine lecture in hospital sit and listen, usually 1-2 times during one week in hospital

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. age ≥18 years
2. duration of type 2 diabetes ≥3 months
3. without any severe complication and impaired cognition.

Exclusion Criteria

1. severe physical handicap or mental illness
2. presence of other serious disease such as cancer and stroke.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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FangFang Zhao

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helena leino-kilpi, PhD

Role: STUDY_CHAIR

Department of Nursing Science, Universtiy of Turku

Locations

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The First People Hospital, Affiliated hospital of Nantong University

Nantong, Jiangsu, China

Site Status

Countries

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China

References

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Zhao FF, Suhonen R, Katajisto J, Stolt M, Leino-Kilpi H. Association between diabetes-related self-care activities and positive health: a cross-sectional study. BMJ Open. 2019 Jul 9;9(7):e023878. doi: 10.1136/bmjopen-2018-023878.

Reference Type DERIVED
PMID: 31289048 (View on PubMed)

Other Identifiers

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BK2014011

Identifier Type: -

Identifier Source: org_study_id