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SchizophreniaNCT04611737

Self-Determination Theory and Motivational Interviewing

A study testing Interviewing in people with Schizophrenia and Diabetes, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Self-Determination Theory and motivational interviewing would be integrated to enhance the efficacy of diabetic self-management for patients with schizophrenia and Type 2 Diabetes. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Schizophrenia, Diabetes
What is being tested?
Interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteTaiwan
Study dates
3 Nov 2020to 24 May 2023
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with schizophrenia and Type 2 Diabetes
  • between 20 years old to 80 years old
  • can communicate in Chinese langue

Who cannot join

  • can not communicate well
  • have neurocognitive disorders

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 807

Other trials in Taiwan

About this study

Official title: Developing and Testing of Integrating Self-Determination Theory and Motivational Interviewing Based Diabetic Self-management Program Among Schizophrenic Patients With Diabetes

Self-Determination Theory and motivational interviewing would be integrated to enhance the efficacy of diabetic self-management for patients with schizophrenia and Type 2 Diabetes.

Read the detailed description

Participants would be randomly allocated into either the intervention group or the usual care group from baseline to 3 months follow-up. The intervention is based on integrated self-determination theory and motivational interviewing.

Being tested
Interviewing
Medical subject headings
Schizophrenia, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterviewingBehavioural

    Self-Determination Theory within motivational interviewing

Study groups in NCT04611737
Study groupRoleWhat they receive
Experimental groupExperimentalThe researcher interviews with participants for 3 times.
Receives: Behavioral: Interviewing
Control groupNo interventionThe participants receive usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1C

    Blood sugar level during the 3 months

    Measured: on interviewing day1, and 3 months

  2. Body weight

    weight (in kilograms)

    Measured: on interviewing day1, and 3 months

  3. height

    height (in meters), eight and height will be combined to report BMI in kg/m^2

    Measured: on interviewing day1, and 3 months

Secondary outcomes (4)

  1. Brief Psychiatric Rating Scale

    The Brief Psychiatric Rating Scale with 18 items is use to measure psychiatric symptoms. Each symptom is rated 1-7 with higher scores indicating severer symptoms.

    Measured: on interviewing day1, and 3 months

  2. Treatment Self-Regulation Questionnaire-Diabetes

    The treatment Self-Regulation Questionnaire-Diabetes a 19-item scale used to examine the self-regulation behaviors for diabetes of participants. Each item is ranged from 1 to 7 and higher scores showing more motivations in self-regulation diabetes.

    Measured: on interviewing day1, and 3 months

  3. Perceived Diabetes Self-Management Scale

    The Perceived Diabetes Self-Management Scale is an 8-item scale with 4 of the items (1, 2, 6, \& 7) being reverse-scored. Each item is ranged from 1 to 5 and higher scores showing more confidence in self-managing diabetes.

    Measured: on interviewing day1, and 3 months

  4. Depression Anxiety Stress Scales

    The Depression Anxiety Stress Scales is a self-report scale with 21 items designed to assess depression, stress and anxiety of participants. Scores for each symptom is ranged from 0 to 3 with higher scores indicating severer symptoms.

    Measured: on interviewing day1, and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2020
  2. Study start3 Nov 2020
  3. Primary completion24 May 2023
  4. Study completion24 May 2023

Resources

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
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04611737
Sponsor's protocol ID
KMUHIRB-SV(I)-20200019
Status last verified
Oct 2020
First submitted
25 Oct 2020
Last updated
16 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Interviewing in people with Schizophrenia and Diabetes, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

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: finished, as of the sponsor's last update on 16 Feb 2024. 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 Taiwan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

HbA1C (time frame: on interviewing day1, and 3 months). The study lists 3 primary outcomes in all. 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 NCT04611737.

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 16 Feb 2024.

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