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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04899752
Other study ID # 20-512 EP 2011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 1, 2022

Study information

Verified date December 2022
Source Auburn University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this project is to examine the differences in outpatient cardiac rehab (OPCR) core component outcomes on different intervention conditions. Conditions include traditional OPCR (control), OPCR + motivational interviewing (MI) and OPCR + Clinician centered interviews.


Description:

Participants who are beginning a OPCR program at a local hospital are eligible for the program. During the standard admission procedures, eligible participants will be provided with a consent from and asked to participate in the study. Participants who provide consent will complete their admission packet. The standard admission packet includes: the Outpatient Fall Assessment Risk, Patient Health Questionnaire (PHQ-9),the Dartmouth Quality of Life, and the Rate Your Plate. In addition participants will complete three additional surveys: the Intrinsic Motivation Inventory (IMI), the FPS, (FACES Pain Scale), and the Brief Resilience Scale (BRS). During their second appointment participants will complete the standard 6 minute walk test which is scheduled at their convenience and the grip strength. Participants will then be randomly assigned to the traditional OPCR, the OPCR + MI, or the OPCR - Clinician centered. Post-testing will include all baseline information as well as information from patients charts (lipid profile, HbA1c, risk factors and family history). Analysis will determine differences in core outcomes between the three groups.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date December 1, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Enrolled in outpatient cardiac rehab - Able to complete the paperwork independently Exclusion Criteria: - Unable to complete assessments and paperwork independently.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Interviewing
Participants will participate in three different communication styles to determine the effect of MI on cardiac rehab outcome measures.

Locations

Country Name City State
United States Auburn University Auburn Alabama

Sponsors (1)

Lead Sponsor Collaborator
Auburn University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence to CR Differences in the number of sessions attended between groups 12 weeks
Primary 6-minute walk Changes in the distance traveled during a 6-minute walk 12 weeks
Primary Rate my plate Changes in heart healthy diet 12 weeks
Primary Dartmouth Quality of Life index Changes in Dartmouth Quality of Life Index. Range is 9-45. Higher score indicates lower quality of life. 12 weeks
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