Cardiac RehabilitationMIOPCRNCT04899752
Motivational Interviewing & Clinician Centered Interviewing on Cardiac Rehab
A study testing Motivational Interviewing in people with Cardiac Rehabilitation and Motivational Interviewing, run by Auburn University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiac Rehabilitation, Motivational Interviewing
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Enrolled in outpatient cardiac rehab
- Able to complete the paperwork independently
Who cannot join
- Unable to complete assessments and paperwork independently.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Rehabilitation, Motivational Interviewing
- Being tested
- Motivational Interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Participants will participate in three different communication styles to determine the effect of MI on cardiac rehab outcome measures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to CR
Differences in the number of sessions attended between groups
Measured: 12 weeks
6-minute walk
Changes in the distance traveled during a 6-minute walk
Measured: 12 weeks
Rate my plate
Changes in heart healthy diet
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Jun 2021
- Primary completion31 Mar 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of three groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle D Wadsworth, Auburn University
- Investigators
- Danielle D Wadsworth, PhD, Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899752
- Sponsor's protocol ID
- 20-512 EP 2011
- Acronym
- MIOPCR
- Status last verified
- Dec 2022
- First submitted
- 8 Feb 2021
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share IPD due to Hippa
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing and Clinician Centered Interviewing Based Cardiac Rehabilitation on Core Outcomes
- ClinicalTrials.gov ID
- NCT04899752
- Acronym / sponsor ID
- MIOPCR / 20-512 EP 2011
- Conditions
- Cardiac Rehabilitation, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three groups.
| Arm | Type | Receives |
|---|---|---|
| Traditional OPCR | Experimental | Behavioral: Motivational InterviewingThose 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. |
| OPCR + MI | Experimental | Behavioral: Motivational InterviewingThe 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. |
| OPCR + Clinician centered | Experimental | Behavioral: Motivational InterviewingThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Enrolled in outpatient cardiac rehab
- Able to complete the paperwork independently
Key exclusion criteria (1 listed)
- Unable to complete assessments and paperwork independently.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingParticipants will participate in three different communication styles to determine the effect of MI on cardiac rehab outcome measures. | Behavioural | OPCR + Clinician centered, OPCR + MI, Traditional OPCR |
Primary outcome
Adherence to CR
Time frame: 12 weeks
Differences in the number of sessions attended between groups
6-minute walk
Time frame: 12 weeks
Changes in the distance traveled during a 6-minute walk
Rate my plate
Time frame: 12 weeks
Changes in heart healthy diet
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: No. We will not share IPD due to Hippa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle D Wadsworth, PhD principal investigator
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Cardiac Rehabilitation and Motivational Interviewing, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to CR (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.