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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02594748
• Other study ID #: BK2014011
• Status: Suspended
• Phase: N/A
• First received: October 27, 2015
• Last updated: October 24, 2016
• Start date: July 2015
• Est. completion date: December 2019

Study information

• Verified date: October 2016
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Jiangsu Province Health Department
• Study type: Interventional

Clinical Trial 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:

1. Self-management education program delivered face to face (intervention group); (b) standard usual care (comparison group).

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 280
• Est. completion date: December 2019
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Self-management education
The intervention group will receive diabetes self-management education based on the idea of extended theory of planned behavior .
• Routine care
They will attend the routine lecture in hospital sit and listen, usually 1-2 times during one week in hospital

Locations

Country	Name	City	State
China	The First People Hospital, Affiliated hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and at three months.	No
Secondary	Change from baseline in Fatigue-14 scale at 3-month follow up.		Baseline,3-month follow up.	No
Secondary	Change from baseline in Well-Being Index (WHO-5)		Baseline,3-month follow up.	No
Secondary	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	Baseline,3-month follow up.	No
Secondary	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.	Baseline,3-month follow up.	No
Secondary	Change from baseline in Connor-Davidson Resilience Scale-10 at 3-month follow up.		Baseline,3-month follow up.	No
Secondary	Change from baseline in HbA1c at 3-month follow up.	HbA1c will be measured at outpatient of hospital.	Baseline, 3-month follow up.	No
Secondary	Change from baseline in BMI at 3-month follow up.	BMI will be measured at hospital and participants' home.	Baseline,3-month follow up.	No
Secondary	Change from baseline in Blood sugar at 3-month follow up.	Blood sugar will be measured at hospital and participants' home.	Baseline,3-month follow up.	No