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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Turku

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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