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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04611737
Other study ID # KMUHIRB-SV(I)-20200019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 3, 2020
Est. completion date May 24, 2023

Study information

Verified date October 2020
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date May 24, 2023
Est. primary completion date May 24, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - patients with schizophrenia and Type 2 Diabetes - between 20 years old to 80 years old - can communicate in Chinese langue Exclusion Criteria: - can not communicate well - have neurocognitive disorders

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Interviewing
Self-Determination Theory within motivational interviewing

Locations

Country Name City State
Taiwan Kaohsiung Medical University Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1C Blood sugar level during the 3 months on interviewing day1, and 3 months
Primary Body weight weight (in kilograms) on interviewing day1, and 3 months
Primary height height (in meters), eight and height will be combined to report BMI in kg/m^2 on interviewing day1, and 3 months
Secondary 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. on interviewing day1, and 3 months
Secondary 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. on interviewing day1, and 3 months
Secondary 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. on interviewing day1, and 3 months
Secondary 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. on interviewing day1, and 3 months
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