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

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

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.

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.

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