Diabetes Mellitus, Type 2NCT02594748
The Effects of Self-management Education Based on Theory of Planned Behavior on Patients With Type 2 Diabetes
A study testing Self-management education and Routine care in people with Diabetes Mellitus, Type 2, run by University of Turku at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Self-management education and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥18 years
- duration of type 2 diabetes ≥3 months
- without any severe complication and impaired cognition.
Who cannot join
- severe physical handicap or mental illness
- presence of other serious disease such as cancer and stroke.
Trial locations and contacts
1 site in 1 country.
China1 site
The First People Hospital, Affiliated hospital of Nantong University
Nantong, Jiangsu, 226001
About this study
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
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).
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Self-management education, Routine care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management educationBehavioural
The intervention group will receive diabetes self-management education based on the idea of extended theory of planned behavior .
Routine careBehavioural
They will attend the routine lecture in hospital sit and listen, usually 1-2 times during one week in hospital
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Behavioral: Self-management education |
| Comparison group | Active comparator | The comparison group will receive routine care Receives: Behavioral: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and at three months.
Secondary outcomes (8)
Change from baseline in Fatigue-14 scale at 3-month follow up.
Measured: Baseline,3-month follow up.
Change from baseline in Well-Being Index (WHO-5)
Measured: Baseline,3-month follow up.
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
Measured: Baseline,3-month follow up.
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.
Measured: Baseline,3-month follow up.
Change from baseline in Connor-Davidson Resilience Scale-10 at 3-month follow up.
Measured: Baseline,3-month follow up.
Change from baseline in HbA1c at 3-month follow up.
HbA1c will be measured at outpatient of hospital.
Measured: Baseline, 3-month follow up.
Change from baseline in BMI at 3-month follow up.
BMI will be measured at hospital and participants' home.
Measured: Baseline,3-month follow up.
Change from baseline in Blood sugar at 3-month follow up.
Blood sugar will be measured at hospital and participants' home.
Measured: Baseline,3-month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2017 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: The voluntary attendance rate for intervention is low.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FangFang Zhao, University of Turku
- Investigators
- Helena leino-kilpi, PhD, Study chair, Department of Nursing Science, Universtiy of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594748
- Sponsor's protocol ID
- BK2014011
- Status last verified
- Oct 2016
- First submitted
- 27 Oct 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31289048
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02594748
- Acronym / sponsor ID
- BK2014011
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The voluntary attendance rate for intervention is low.
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Self-management educationIntervention 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. |
| Comparison group | Active comparator | Behavioral: Routine careThe comparison group will receive routine care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 years
- duration of type 2 diabetes ≥3 months
- without any severe complication and impaired cognition.
Key exclusion criteria (2 listed)
- severe physical handicap or mental illness
- presence of other serious disease such as cancer and stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management educationThe intervention group will receive diabetes self-management education based on the idea of extended theory of planned behavior . | Behavioural | Experimental group |
| Routine careThey will attend the routine lecture in hospital sit and listen, usually 1-2 times during one week in hospital | Behavioural | Comparison group |
Primary outcome
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.
8 secondary outcomes
Change from baseline in Fatigue-14 scale at 3-month follow up.
Time frame: Baseline,3-month follow up.
Change from baseline in Well-Being Index (WHO-5)
Time frame: 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.
Change from baseline in self-management planned behavior developed according to guideline at 3-month follow up.
Time frame: 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.
Change from baseline in HbA1c at 3-month follow up.
Time frame: Baseline, 3-month follow up.
Change from baseline in BMI at 3-month follow up.
Time frame: Baseline,3-month follow up.
Change from baseline in Blood sugar at 3-month follow up.
Time frame: Baseline,3-month follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Derived from this study: PubMed 31289048Zhao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena leino-kilpi, PhD study chair
Department of Nursing Science, Universtiy of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management education and Routine care in people with Diabetes Mellitus, Type 2, run by University of Turku at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Audit of Diabetes Dependent Quality of Life at 3-month follow up. (time frame: baseline and at three months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02594748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.