Clinical trial NCT02594748: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

  1. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Audit of Diabetes Dependent Quality of Life at 3-month follow up.
timeFrame: baseline and at three months.
Secondary outcomes:
measure: Change from baseline in Fatigue-14 scale at 3-month follow up.
timeFrame: Baseline,3-month follow up.
measure: Change from baseline in Well-Being Index (WHO-5)
timeFrame: Baseline,3-month follow up.
measure: Change from baseline in The Summary of Diabetes Self-Care Activities Measure at 3-month follow up.
timeFrame: Baseline,3-month follow up.
measure: Change from baseline in self-management planned behavior developed according to guideline at 3-month follow up.
timeFrame: Baseline,3-month follow up.
measure: Change from baseline in Connor-Davidson Resilience Scale-10 at 3-month follow up.
timeFrame: Baseline,3-month follow up.
measure: Change from baseline in HbA1c at 3-month follow up.
timeFrame: Baseline, 3-month follow up.
measure: Change from baseline in BMI at 3-month follow up.
timeFrame: Baseline,3-month follow up.
measure: Change from baseline in Blood sugar at 3-month follow up.
timeFrame: Baseline,3-month follow up.
Other outcomes:
Locations:
city: Nantong
country: China
facility: The First People Hospital, Affiliated hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Department of Nursing Science, Universtiy of Turku
name: Helena leino-kilpi, PhD
role: STUDY_CHAIR
References:
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.