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

October 24, 2016 updated by: FangFang Zhao, University of Turku

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

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).

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nantong, Jiangsu, China, 226001
        • The First People Hospital, Affiliated hospital of Nantong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Self-management education
The intervention group will receive diabetes self-management education based on the idea of extended theory of planned behavior .
Active Comparator: Comparison group
The comparison group will receive routine care
Behavioral: Routine care
They will attend the routine lecture in hospital sit and listen, usually 1-2 times during one week in hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and at three months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Fatigue-14 scale at 3-month follow up.
Time Frame: Baseline,3-month follow up.
Baseline,3-month follow up.
Change from baseline in Well-Being Index (WHO-5)
Time Frame: Baseline,3-month follow up.
Baseline,3-month follow up.
Change from baseline in The Summary of Diabetes Self-Care Activities Measure at 3-month follow up.
Time Frame: Baseline,3-month follow up.
The scale include diet, exercise, medication, foot care and blood sugar monitoring
Baseline,3-month follow up.
Change from baseline in self-management planned behavior developed according to guideline at 3-month follow up.
Time Frame: 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.
Baseline,3-month follow up.
Change from baseline in Connor-Davidson Resilience Scale-10 at 3-month follow up.
Time Frame: Baseline,3-month follow up.
Baseline,3-month follow up.
Change from baseline in HbA1c at 3-month follow up.
Time Frame: Baseline, 3-month follow up.
HbA1c will be measured at outpatient of hospital.
Baseline, 3-month follow up.
Change from baseline in BMI at 3-month follow up.
Time Frame: Baseline,3-month follow up.
BMI will be measured at hospital and participants' home.
Baseline,3-month follow up.
Change from baseline in Blood sugar at 3-month follow up.
Time Frame: Baseline,3-month follow up.
Blood sugar will be measured at hospital and participants' home.
Baseline,3-month follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Investigators

  • Study Chair: Helena leino-kilpi, PhD, Department of Nursing Science, Universtiy of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

October 31, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BK2014011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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