NCT04899752

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

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

February 8, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

February 8, 2021

Last Update Submit

December 21, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Adherence to CR

    Differences in the number of sessions attended between groups

    12 weeks

  • 6-minute walk

    Changes in the distance traveled during a 6-minute walk

    12 weeks

  • Rate my plate

    Changes in heart healthy diet

    12 weeks

  • 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

Study Arms (3)

Traditional OPCR

EXPERIMENTAL

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.

Behavioral: Motivational Interviewing

OPCR + MI

EXPERIMENTAL

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.

Behavioral: Motivational Interviewing

OPCR + Clinician centered

EXPERIMENTAL

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.

Behavioral: Motivational Interviewing

Interventions

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

OPCR + Clinician centeredOPCR + MITraditional OPCR

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in outpatient cardiac rehab
  • Able to complete the paperwork independently

You may not qualify if:

  • Unable to complete assessments and paperwork independently.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Danielle D Wadsworth, PhD

    Auburn University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be award of group assignments as all participants are provided a face-to-face interaction with the provider.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of three groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2021

First Posted

May 24, 2021

Study Start

June 1, 2021

Primary Completion

March 31, 2022

Study Completion

December 1, 2022

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

We will not share IPD due to Hippa

Locations