Congestive Heart Failure TreatedNCT06904144
Health Coaching for Patients With Cardiovascular Disease
A study testing Health Coaching in people with Congestive Heart Failure Treated and Myocardial Infarction (MI), run by Ohio State University at 1 site in United States.
Trial summary
For patients discharged with a diagnosis of cardiovascular disease coronary artery disease resulting in myocardial infarction and/or congestive heart failure, this study will evaluate if the addition of 12 virtual health coaching sessions over the course of 16 weeks will improve physiological, psychological, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure Treated, Myocardial Infarction (MI), Coronary Artery Disease
- What is being tested?
- Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- diagnosis of coronary artery disease resulting in myocardial infarction and/or congestive heart failure
- physical condition effectively managed by routine healthcare and not requiring urgent medical attention
- ability to communicate in English
- access to a working phone or computer and ability to communicate via phone or computer.
Who cannot join
- Patients who have had chest coronary artery bypass surgery
- Documented cognitive and/or major psychiatric disorders, including dementia, Alzheimer's, depression or anxiety uncontrolled by anxiolytic, anti-psychotic, and/or anti-depressants and/or PHQ-9 score 15-27 and GAD-7 score >15
- current alcohol or drug dependency
- resident of extended care/skilled facility
- prisoners or ward of state.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Beth Steinberg, PhD, RN, 614-406-7067, steinberg.35@osu.edu
Maryanna Klatt, PhD, 614-293-3644, Klatt.8@osu.edu
About this study
Official title: Health Coaching for Patients With Cardiovascular Disease: A Mixed-Methods Evaluation of the Impact on Patient Outcomes and Provider Satisfaction and Acceptability
For patients discharged with a diagnosis of cardiovascular disease coronary artery disease resulting in myocardial infarction and/or congestive heart failure, this study will evaluate if the addition of 12 virtual health coaching sessions over the course of 16 weeks will improve physiological, psychological, and social health outcomes, prove acceptable and satisfactory for these patients with CVD, decrease CVD-related questions and concerns sent to the provider via MyChart, and reduce hospital readmission rates over a 90-day period as compared to patients discharged with the same diagnosis who receive standard post-discharge care. The study will also evaluate the perceptions of physician and advanced practice providers related to the health coach as part of the interprofessional team and the amount of time spent addressing CVD-related patient questions and concerns via MyChart messages.
Read the detailed description
The purpose of this mixed methods study is to evaluate the impact of 12 virtual health coaching sessions, provided post-discharge, over the course of 16 weeks on: 1) patient physiological measure of weight; 2) patient-reported perceived stress, anxiety, depression, and medication adherence, and physical, emotional, and social lifestyle behaviors; and 3) MyChart messaging to their providers related to concerns and/or questions about their cardiovascular diagnosis. The study will also assess: 4) patient acceptability and satisfaction with the health coaching intervention; 5) acceptability and satisfaction value and/or importance of the health coach intervention and feasibility of integrating the health coach into the inter-professional care team from the provider perspective; impact of the health coaching intervention on provider time spent on addressing MyChart messages; and 6) 30-, 60-, and 90-day hospital readmission rates.
- Conditions
- Congestive Heart Failure Treated, Myocardial Infarction (MI), Coronary Artery Disease, Congestive Heart Failure Chronic
- Being tested
- Health Coaching
- Keywords
- health coaching, coronary artery disease, congestive heart failure, myocardial infarction
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
12 virtual health coaching sessions will be provided over a 16 week period by a certified health coach.
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching Intervention Group | Experimental | Participants will receive 12 health coaching sessions post-discharge over a 16 week period Receives: Behavioral: Health Coaching |
| Standard Care Group | No intervention | Participants will receive usual post-discharge care over the 16 week period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Patient body weight in kilograms will be obtained by clinical staff on hospital approved and calibrated electronic standing scales. The patient's body weight will be collected from the patient's electronic medical record.
Measured: Baseline (day of hospital discharge) and at provider appointment in the ambulatory setting, 16 weeks post-hospital discharge
Hospital readmissions
Hospital readmissions for an inpatient stay, documented in the electronic medical record, after the hospital post-discharge for cardiovascular disease
Measured: Hospital readmissions during the 30-, 60-, and 90-days post-hospital discharge for cardiovascular disease, documented in the electronic medical record
MyChart messages
MyChart messages are questions or requests directed to the patient's provider that are related to the patient's cardiovascular disease diagnosis and hospitalization. These MyChart messages are entered into the electronic medical record by the patient and are directed to their provider, requiring an electronic or telephone response to the patient with a documented note entered by the provider relative to the follow-up provided to the patient. This outcome measure will be the number of MyChart messages entered by the patient and responded to by the provider.
Measured: Over the course of 16 weeks, from hospital discharge to 16 weeks post-hospital discharge
Perceived Stress
Perceived Stress Scale-10 (PSS-10). A 10-item self-report measure of perceived stress. It is a measure of the degree to which situations in one's life are appraised as stressful over the past month. The 4-point Likert Scale includes responses of 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), and 4 (very often). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Baseline (hospital discharge), 8 weeks post-hospital discharge, and 16 weeks post-hospital discharge
Medication Adherence
The Hill-Bone Medication Adherence Scale (MB-MAS) is a 9-item self-assessment of medication adherence relative to a variety of chronic diseases and conditions. Likert Scale responses to each of the nine statements include 1 (all of the time), 2 (most of the time), 3 (some of the time), and 4 (none of the time). Total scores range from 4 to 36 with higher scores indicating higher medication adherence.
Measured: Baseline, and at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge
Lifestyle Medicine Behavior Assessment
The Lifestyle Medicine Short Form is a 14-item self-assessment scale evaluating physical, emotional, social lifestyle behaviors. The assessment questions comprise core metrics that capture readiness to change, as well as health behaviors that are aligned with the six pillars of lifestyle medicine--physical activity, nutrition, sleep health, stress reduction, social connections, and risky substances. Questions have multiple responses based on information relating to the six pillars of lifestyle medicine. The first two questions related to Readiness to Change use a Likert Scale ranging from 0 (Not Ready) to 10 (Very Ready). Questions related to Motivation and Diet request that the participant denote different aspects of their diet. Physical exercise questions request specific days/times in minutes completed. Questions related to sleep request average hours of sleep per 24 hour period. Mood, connectedness with others, and substance use request types/amounts per week.
Measured: Completed at baseline, at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge
Acceptability of Intervention Measure
The Acceptability of Intervention Measure (AIM) is a 4-item self-report assessment to evaluate the acceptability of the health coaching intervention. Each statement is scored with a 5-point Likert Scale that includes 1 (completely disagree), 2 (disagree), 3 (neither agree nor disagree), 4 (agree), and 5 (completely agree). Total scores ranges from 4-20 with higher total scores indicating higher acceptability.
Measured: Completed after the 16 week health coaching intervention for participants in the intervention group.
Secondary outcomes (4)
Patient Qualitative Comments
Patient perceptions of the health coaching intervention will be solicited with the following question prompts: 1) Can you provide feedback about your health coaching experience?; 2) Did working with the health coach help you meet your health goals?; 3) Would you recommend working with a health coach to others?
Measured: Immediately after completion of the 16 week health coaching intervention; i.e. 16 weeks post-hospital discharge
Provider Qualitative Comments
Provider perceptions of the value of the health coach as part of the interprofessional team and the feasibility of integrating the health coach into the patient's care will be solicited via question prompts that will include: 1) Can you discuss your perceptions about the value of the health coach as a member of the patient's care team; 2) Were you able to review the health coaches notes in the patient's medical record? (if yes) Were the notes helpful to you during the patient's follow-up appointment(s), i.e. in addressing the patient's condition, their post-discharge recovery, adherence to medical instructions, progress or lack of progress?; 3) Can you provide your perceptions of the feasibility of integrating the health coach as part of the patient's care team?
Measured: Will be completed within one month of their patient completing the health coach intervention.
Patient Health Questionnaire (PHQ-9)
A 9-item depression module the Patient Health Questionnaire that scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day); scores range from 9-27.
Measured: Baseline, 4-, 8-, and 16 weeks post-discharge for all participants
Generalized Anxiety Disorder-7 (GAD-7)
A 7-item screening tool assessing anxiety over the past 2 weeks. Questions are scored from "0" (not at all) to "3" (nearly every day). Scores range from 0-21.
Measured: Baseline, 4-, 8-, and 16 weeks post-discharge for all participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure TreatedStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Steinberg, Ohio State University
- Investigators
- Beth Steinberg, PhD, RN, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904144
- Sponsor's protocol ID
- 2024H0179
- Status last verified
- Dec 2025
- First submitted
- 3 Mar 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that will be shared will include de-identified descriptive data for both the intervention and control groups, including gender, race, educational level and mean age. Additionally, cardiovascular disease diagnoses, hospital readmissions at 30-, 60-, and 90- days post-hospital discharge, and number of MyChart messages sent by the patient to their provider. Acceptability of the intervention descriptive data for the intervention group will also be included. Differences in mean scores between the intervention and control groups for weight (significance and effect sizes), perceived stress and medication adherence will be shared. De-identified, curated qualitative data that will be shared includes interview transcripts from both patients and providers, as well as the qualitative codebooks and thematic analysis.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Coaching for Patients With Cardiovascular Disease: A Mixed-Methods Evaluation of the Impact on Patient Outcomes and Provider Satisfaction and Acceptability
- ClinicalTrials.gov ID
- NCT06904144
- Acronym / sponsor ID
- 2024H0179
- Conditions
- Congestive Heart Failure Treated, Myocardial Infarction (MI), Coronary Artery Disease, Congestive Heart Failure Chronic
- Keywords
- health coaching, coronary artery disease, congestive heart failure, myocardial infarction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 1 Apr 2025 (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.
For patients discharged with a diagnosis of cardiovascular disease coronary artery disease resulting in myocardial infarction and/or congestive heart failure, this study will evaluate if the addition of 12 virtual health coaching sessions over the course of 16 weeks will improve physiological, psychological, and social health outcomes, prove acceptable and satisfactory for these patients with CVD, decrease CVD-related questions and concerns sent to the provider via MyChart, and reduce hospital readmission rates over a 90-day period as compared to patients discharged with the same diagnosis who receive standard post-discharge care. The study will also evaluate the perceptions of physician and advanced practice providers related to the health coach as part of the interprofessional team and the amount of time spent addressing CVD-related patient questions and concerns via MyChart messages.
Detailed description
The purpose of this mixed methods study is to evaluate the impact of 12 virtual health coaching sessions, provided post-discharge, over the course of 16 weeks on: 1) patient physiological measure of weight; 2) patient-reported perceived stress, anxiety, depression, and medication adherence, and physical, emotional, and social lifestyle behaviors; and 3) MyChart messaging to their providers related to concerns and/or questions about their cardiovascular diagnosis. The study will also assess: 4) patient acceptability and satisfaction with the health coaching intervention; 5) acceptability and satisfaction value and/or importance of the health coach intervention and feasibility of integrating the health coach into the inter-professional care team from the provider perspective; impact of the health coaching intervention on provider time spent on addressing MyChart messages; and 6) 30-, 60-, and 90-day hospital readmission rates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Coaching Intervention Group | Experimental | Behavioral: Health CoachingParticipants will receive 12 health coaching sessions post-discharge over a 16 week period |
| Standard Care Group | No intervention | –Participants will receive usual post-discharge care over the 16 week period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- diagnosis of coronary artery disease resulting in myocardial infarction and/or congestive heart failure
- physical condition effectively managed by routine healthcare and not requiring urgent medical attention
- ability to communicate in English
- access to a working phone or computer and ability to communicate via phone or computer.
Key exclusion criteria (5 listed)
- Patients who have had chest coronary artery bypass surgery
- Documented cognitive and/or major psychiatric disorders, including dementia, Alzheimer's, depression or anxiety uncontrolled by anxiolytic, anti-psychotic, and/or anti-depressants and/or PHQ-9 score 15-27 and GAD-7 score >15
- current alcohol or drug dependency
- resident of extended care/skilled facility
- prisoners or ward of state.
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 |
|---|---|---|
| Health Coaching12 virtual health coaching sessions will be provided over a 16 week period by a certified health coach. | Behavioural | Health Coaching Intervention Group |
Primary outcome
Body weight
Time frame: Baseline (day of hospital discharge) and at provider appointment in the ambulatory setting, 16 weeks post-hospital discharge
Patient body weight in kilograms will be obtained by clinical staff on hospital approved and calibrated electronic standing scales. The patient's body weight will be collected from the patient's electronic medical record.
Hospital readmissions
Time frame: Hospital readmissions during the 30-, 60-, and 90-days post-hospital discharge for cardiovascular disease, documented in the electronic medical record
Hospital readmissions for an inpatient stay, documented in the electronic medical record, after the hospital post-discharge for cardiovascular disease
MyChart messages
Time frame: Over the course of 16 weeks, from hospital discharge to 16 weeks post-hospital discharge
MyChart messages are questions or requests directed to the patient's provider that are related to the patient's cardiovascular disease diagnosis and hospitalization. These MyChart messages are entered into the electronic medical record by the patient and are directed to their provider, requiring an electronic or telephone response to the patient with a documented note entered by the provider relative to the follow-up provided to the patient. This outcome measure will be the number of MyChart messages entered by the patient and responded to by the provider.
Perceived Stress
Time frame: Baseline (hospital discharge), 8 weeks post-hospital discharge, and 16 weeks post-hospital discharge
Perceived Stress Scale-10 (PSS-10). A 10-item self-report measure of perceived stress. It is a measure of the degree to which situations in one's life are appraised as stressful over the past month. The 4-point Likert Scale includes responses of 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), and 4 (very often). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Medication Adherence
Time frame: Baseline, and at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge
The Hill-Bone Medication Adherence Scale (MB-MAS) is a 9-item self-assessment of medication adherence relative to a variety of chronic diseases and conditions. Likert Scale responses to each of the nine statements include 1 (all of the time), 2 (most of the time), 3 (some of the time), and 4 (none of the time). Total scores range from 4 to 36 with higher scores indicating higher medication adherence.
Lifestyle Medicine Behavior Assessment
Time frame: Completed at baseline, at 8 weeks post-hospital discharge and at 16 weeks post-hospital discharge
The Lifestyle Medicine Short Form is a 14-item self-assessment scale evaluating physical, emotional, social lifestyle behaviors. The assessment questions comprise core metrics that capture readiness to change, as well as health behaviors that are aligned with the six pillars of lifestyle medicine--physical activity, nutrition, sleep health, stress reduction, social connections, and risky substances. Questions have multiple responses based on information relating to the six pillars of lifestyle medicine. The first two questions related to Readiness to Change use a Likert Scale ranging from 0 (Not Ready) to 10 (Very Ready). Questions related to Motivation and Diet request that the participant denote different aspects of their diet. Physical exercise questions request specific days/times in minutes completed. Questions related to sleep request average hours of sleep per 24 hour period. Mood, connectedness with others, and substance use request types/amounts per week.
Acceptability of Intervention Measure
Time frame: Completed after the 16 week health coaching intervention for participants in the intervention group.
The Acceptability of Intervention Measure (AIM) is a 4-item self-report assessment to evaluate the acceptability of the health coaching intervention. Each statement is scored with a 5-point Likert Scale that includes 1 (completely disagree), 2 (disagree), 3 (neither agree nor disagree), 4 (agree), and 5 (completely agree). Total scores ranges from 4-20 with higher total scores indicating higher acceptability.
4 secondary outcomes
Patient Qualitative Comments
Time frame: Immediately after completion of the 16 week health coaching intervention; i.e. 16 weeks post-hospital discharge
Provider Qualitative Comments
Time frame: Will be completed within one month of their patient completing the health coach intervention.
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 4-, 8-, and 16 weeks post-discharge for all participants
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, 4-, 8-, and 16 weeks post-discharge for all participants
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. IPD that will be shared will include de-identified descriptive data for both the intervention and control groups, including gender, race, educational level and mean age. Additionally, cardiovascular disease diagnoses, hospital readmissions at 30-, 60-, and 90- days post-hospital discharge, and number of MyChart messages sent by the patient to their provider. Acceptability of the intervention descriptive data for the intervention group will also be included. Differences in mean scores between the intervention and control groups for weight (significance and effect sizes), perceived stress and medication adherence will be shared. De-identified, curated qualitative data that will be shared includes interview transcripts from both patients and providers, as well as the qualitative codebooks and thematic analysis.
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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.
Beth Steinberg, PhD, RN principal investigator
Ohio State 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 Health Coaching in people with Congestive Heart Failure Treated and Myocardial Infarction (MI), run by Ohio State 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beth Steinberg, PhD, RN (614-406-7067, steinberg.35@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Baseline (day of hospital discharge) and at provider appointment in the ambulatory setting, 16 weeks post-hospital discharge). The study lists 7 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 1 Jul 2026.