NCT06480006

Brief Summary

Scales for biopsychosocial assessment of coronary artery disease patients are limited. The aim of this study was to evaluate the validity and reliability of the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ) in patients with CAD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

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

Study Start

First participant enrolled

June 10, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

June 24, 2024

Last Update Submit

December 19, 2025

Conditions

Keywords

BETY- Biopsychosocial Questionnaire (BETY-BQ)ValidityReliabilityCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Biopsychosocial Characteristics

    Assessment of Biopsychosocial Characteristics: BETY-Biopsychosocial Questionnaire:It offers a measurement between 0-120 values as scoring. The sub-dimensions score range is Pain 0-20, Functionality 0-36, Emotional State 0-40, Sociability 0-12, Sexuality 0-8, Sleep 0-4. It gives the opportunity to evaluate individuals with both sub-dimensions and total score. A high score indicates low quality of life and poor biopsychosocial status.

    One Year

Secondary Outcomes (5)

  • Quality of life

    One Year

  • Kinesiophobia

    One Year

  • Anxiety and Depression

    One Year

  • Cardiovascular Disease Risk Scoring

    One Year

  • Functional Status

    One Year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18-80 years who were diagnosed with coronary artery disease (CAD) in the Department of Internal Medicine, Division of General Internal Medicine, Hacettepe University Hospital and who volunteered to participate in the study will be included in the study.

You may qualify if:

  • To be between the ages of 18-80
  • Volunteering to participate in the research
  • Having coronary artery disease (CAD)
  • Having no problem in reading and/or understanding the scales and being able to cooperate with the tests.

You may not qualify if:

  • Active infection,
  • No history of myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty or bypass surgery in file records and medical history,
  • Having a neurological disease or other clinical diagnosis that may affect cognitive status.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, State, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 28, 2024

Study Start

June 10, 2024

Primary Completion

May 8, 2025

Study Completion

May 8, 2025

Last Updated

December 26, 2025

Record last verified: 2025-12

Locations