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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Suspended
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Self-management education
Routine care
Sponsored by
University of Turku
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The First People Hospital, Affiliated hospital of Nantong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Comparison group

Arm 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.

The comparison group will receive routine care

Outcomes

Primary Outcome Measures

Change from baseline in Audit of Diabetes Dependent Quality of Life at 3-month follow up.
Measure the impact and important of 19 life domains.

Secondary Outcome Measures

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

Full Information

First Posted
October 27, 2015
Last Updated
October 24, 2016
Sponsor
University of Turku
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1. Study Identification

Unique Protocol Identification Number
NCT02594748
Brief Title
The Effects of Self-management Education Based on Theory of Planned Behavior on Patients With Type 2 Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Suspended
Why Stopped
The voluntary attendance rate for intervention is low.
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm 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.
Arm Title
Comparison group
Arm Type
Active Comparator
Arm Description
The comparison group will receive routine care
Intervention Type
Behavioral
Intervention Name(s)
Self-management education
Intervention Description
The intervention group will receive diabetes self-management education based on the idea of extended theory of planned behavior .
Intervention Type
Behavioral
Intervention Name(s)
Routine care
Intervention Description
They will attend the routine lecture in hospital sit and listen, usually 1-2 times during one week in hospital
Primary Outcome Measure Information:
Title
Change from baseline in Audit of Diabetes Dependent Quality of Life at 3-month follow up.
Description
Measure the impact and important of 19 life domains.
Time Frame
baseline and at three months.
Secondary Outcome Measure Information:
Title
Change from baseline in Fatigue-14 scale at 3-month follow up.
Time Frame
Baseline,3-month follow up.
Title
Change from baseline in Well-Being Index (WHO-5)
Time Frame
Baseline,3-month follow up.
Title
Change from baseline in The Summary of Diabetes Self-Care Activities Measure at 3-month follow up.
Description
The scale include diet, exercise, medication, foot care and blood sugar monitoring
Time Frame
Baseline,3-month follow up.
Title
Change from baseline in self-management planned behavior developed according to guideline at 3-month follow up.
Description
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.
Time Frame
Baseline,3-month follow up.
Title
Change from baseline in Connor-Davidson Resilience Scale-10 at 3-month follow up.
Time Frame
Baseline,3-month follow up.
Title
Change from baseline in HbA1c at 3-month follow up.
Description
HbA1c will be measured at outpatient of hospital.
Time Frame
Baseline, 3-month follow up.
Title
Change from baseline in BMI at 3-month follow up.
Description
BMI will be measured at hospital and participants' home.
Time Frame
Baseline,3-month follow up.
Title
Change from baseline in Blood sugar at 3-month follow up.
Description
Blood sugar will be measured at hospital and participants' home.
Time Frame
Baseline,3-month follow up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena leino-kilpi, PhD
Organizational Affiliation
Department of Nursing Science, Universtiy of Turku
Official's Role
Study Chair
Facility Information:
Facility Name
The First People Hospital, Affiliated hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31289048
Citation
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.
Results Reference
derived

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

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