- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04899752
Motivational Interviewing & Clinician Centered Interviewing on Cardiac Rehab (MIOPCR)
December 21, 2022 updated by: Danielle D Wadsworth, Auburn University
The Effect of Motivational Interviewing and Clinician Centered Interviewing Based Cardiac Rehabilitation on Core Outcomes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Danielle D Wadsworth, PhD
- Phone Number: 3347501642
- Email: wadswdd@auburn.edu
Study Locations
-
-
Alabama
-
Auburn, Alabama, United States, 36849
- Auburn University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Enrolled in outpatient cardiac rehab
- Able to complete the paperwork independently
Exclusion Criteria:
- Unable to complete assessments and paperwork independently.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Traditional OPCR
Those who are in the traditional group will discuss topics like medication adherence, physical activity questions, or eating habits without a clear from of autonomy or nonautonomy basis as is currently completed in OPCR.
This will occur in a face to face format.
|
Participants will participate in three different communication styles to determine the effect of MI on cardiac rehab outcome measures.
|
Experimental: OPCR + MI
The MI group will be consistent with the spirit of MI and utilize a high autonomy communication style to provide support for behavior change across multiple behaviors.
This will occur in a face to face format.
|
Participants will participate in three different communication styles to determine the effect of MI on cardiac rehab outcome measures.
|
Experimental: OPCR + Clinician centered
The OPCR + CC group will participate in low-autonomy face to face interviews.
Meaning the communication style will be clinician centered, providing goals to the participants without valuing their input.
|
Participants will participate in three different communication styles to determine the effect of MI on cardiac rehab outcome measures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to CR
Time Frame: 12 weeks
|
Differences in the number of sessions attended between groups
|
12 weeks
|
6-minute walk
Time Frame: 12 weeks
|
Changes in the distance traveled during a 6-minute walk
|
12 weeks
|
Rate my plate
Time Frame: 12 weeks
|
Changes in heart healthy diet
|
12 weeks
|
Dartmouth Quality of Life index
Time Frame: 12 weeks
|
Changes in Dartmouth Quality of Life Index.
Range is 9-45.
Higher score indicates lower quality of life.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Danielle D Wadsworth, PhD, Auburn University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
March 31, 2022
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
February 8, 2021
First Submitted That Met QC Criteria
May 20, 2021
First Posted (Actual)
May 24, 2021
Study Record Updates
Last Update Posted (Actual)
December 23, 2022
Last Update Submitted That Met QC Criteria
December 21, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 20-512 EP 2011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
We will not share IPD due to Hippa
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiac Rehabilitation
-
Ivy susanne Modrau, MDAalborg University HospitalNot yet recruitingCardiac RehabilitationDenmark
-
Mayo ClinicRecruitingCardiac RehabilitationUnited States
-
Defactum, Central Denmark RegionRecruiting
-
University of Central LancashireUniversity of Hull; Sheffield Hallam University; Leeds Beckett UniversityWithdrawnCardiac RehabilitationUnited Kingdom
-
University of North Carolina, Chapel HillNational Institutes of Health (NIH)CompletedCardiac RehabilitationUnited States
-
Texas A&M UniversityAscension HealthNot yet recruiting
-
Shanghai Zhongshan HospitalNot yet recruiting
-
Jessa HospitalCompleted
-
The Cleveland ClinicCompleted
-
China National Center for Cardiovascular DiseasesNot yet recruiting
Clinical Trials on Motivational Interviewing
-
Massachusetts General HospitalRecruitingDiabetes Mellitus, Type 2United States
-
University of Maryland, BaltimoreMaryland Department of Health and Mental HygieneCompletedFractures, Bone | Smoking, TobaccoUnited States
-
Johns Hopkins UniversityZanvyl and Isabelle Krieger FundCompleted
-
Massachusetts General HospitalCompletedACS - Acute Coronary SyndromeUnited States
-
Washington University School of MedicineNational Institute of Mental Health (NIMH)Completed
-
Qazvin University Of Medical SciencesCompletedObesity, AdolescentIran, Islamic Republic of
-
Veterans Medical Research FoundationThe Tug McGraw FoundationCompleted
-
University of MichiganNational Heart, Lung, and Blood Institute (NHLBI); University of Iowa; American... and other collaboratorsCompletedChildhood ObesityUnited States
-
University of StellenboschUniversity of British Columbia; McMaster UniversityCompletedText Messaging Plus Motivational Interviewing in Promotion of Breastfeeding Among HIV-infected WomenHIV Infections | Breast FeedingSouth Africa
-
Centre Hospitalier Universitaire, AmiensRecruitingChronic Disease | Motivational InterviewingFrance