NCT04611737

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

November 3, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2023

Completed
Last Updated

February 16, 2024

Status Verified

October 1, 2020

Enrollment Period

2.6 years

First QC Date

October 25, 2020

Last Update Submit

February 14, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • HbA1C

    Blood sugar level during the 3 months

    on interviewing day1, and 3 months

  • Body weight

    weight (in kilograms)

    on interviewing day1, and 3 months

  • height

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

    on interviewing day1, and 3 months

Secondary Outcomes (4)

  • Brief Psychiatric Rating Scale

    on interviewing day1, and 3 months

  • Treatment Self-Regulation Questionnaire-Diabetes

    on interviewing day1, and 3 months

  • Perceived Diabetes Self-Management Scale

    on interviewing day1, and 3 months

  • Depression Anxiety Stress Scales

    on interviewing day1, and 3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

The researcher interviews with participants for 3 times.

Behavioral: Interviewing

Control group

NO INTERVENTION

The participants receive usual care.

Interventions

InterviewingBEHAVIORAL

Self-Determination Theory within motivational interviewing

Experimental group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • can not communicate well
  • have neurocognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

SchizophreniaDiabetes Mellitus

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ching-Yun Yu, PhD

    Assistant professor, School of Nursing, Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2020

First Posted

November 2, 2020

Study Start

November 3, 2020

Primary Completion

May 24, 2023

Study Completion

May 24, 2023

Last Updated

February 16, 2024

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations