Coronary Heart DiseasePaTHNCT00926848
Reducing Risk in Cardiac Rehabilitation: Partners Together in Health (PaTH) Intervention Study
A study testing Partners Together in Health (PaTH) Intervention in people with Coronary Heart Disease and Cardiac Rehabilitation, run by University of Nebraska at 1 site in United States.
Trial summary
The objective of the proposed study, using an experimental, two-group (n = 30 couples in each group) repeated measures design, was to pilot test the effects of the PaTH Intervention versus a usual care group in improving the following outcomes: a) physical activity and healthy eating behaviors, and b) functional… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Cardiac Rehabilitation
- What is being tested?
- Partners Together in Health (PaTH) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2009to 1 Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 19 or older
- diagnosis of first-time coronary artery bypass graft surgery (CABGs) and enrollment in outpatient CR
- married or living with partner for more than 1 year
- partner is also willing to participate
- no history of psychiatric illness
- classified as low to moderate risk for the occurrence of cardiac events during exercise (AACVPR, 2004).
Show all 12Show fewer
- first-time CABG patients
- Eligible partners will:
- be age 19 or older
- have no history of psychiatric illness
- be classified as low to moderate risk for the occurrence of cardiac events during exercise
- have written permission from the partner's primary health care provider to participate in the study.
Who cannot join
- orthopedic problems that would prevent them from walking or exercising
- history of cardiac arrest, sudden death, complex dysrhythmias at rest, or CHF diagnosis
- resting systolic BP > 200 mmHg or diastolic BP > 100 mmHg
- a concomitant diagnosis or procedure such as valve repair/replacement or aneurysmectomy
- debilitating non-cardiac disease such as renal failure or anemia
- severe chronic obstructive lung disease (FEV1 < 1 liter)
- poorly controlled diabetics (diagnosed with diabetic ketoacidosis within the past 6 months or a current HgA1c > 11).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
The objective of the proposed study, using an experimental, two-group (n = 30 couples in each group) repeated measures design, was to pilot test the effects of the PaTH Intervention versus a usual care group in improving the following outcomes: a) physical activity and healthy eating behaviors, and b) functional capacity. The primary outcomes will be physical activity behavior (minutes per week) and eating behavior (percent saturated fat) at the 6 month time point in both the coronary artery bypass graft (CABG) patient and his/her partner. Secondary outcome includes functional capacity in patients and partners at 6 months.
Read the detailed description
Long-term maintenance of lifestyle changes to reduce cardiovascular risk factors after coronary artery bypass graft (CABG) surgery is essential to positively influence health outcomes. Despite proven efficacy of cardiac rehabilitation (CR) in helping patients initiate lifestyle changes, less than 50% of CABG patients maintain lifestyle changes by 6 months post-CABG. It is known that the spouse is the main source of social support for the recovering cardiac patient and frequently attends cardiac rehabilitation with the patient to provide transportation, emotional support, or attend educational classes. In spite of these supportive behaviors, however; adherence still drops off after CR. Lifestyle interventions that specifically target the marital partners as a unit may be more efficacious than current individually-oriented education strategies. The objective of the proposed feasibility study, using an experimental, two-group (n = 30 couples in each group) repeated measures design, will be to pilot test the effects of the Partners Together in Health (PaTH) Intervention versus usual care in improving physical activity and healthy eating behaviors, and functional capacity. The specific aims are to assess the feasibility of implementing the PaTH Intervention and generate pilot data on all outcome variables in both the CABG patient and the partner to estimate effect sizes needed to determine the sample size requirements for the larger study. Partners in the PaTH Intervention group will formally join CR with the patient to participate in exercise sessions and educational classes to undertake comprehensive risk reduction for themselves, and to make the same positive physical activity/exercise and healthy eating lifestyle changes as the patient. Partners in the usual care group will be invited to attend the educational sessions with the patient as is currently usual care. The primary outcomes will be physical activity behavior (minutes per week) and eating behavior (percent saturated fat) at the 6 month time point in both the coronary artery bypass graft (CABG) patient and his/her partner. The secondary outcome includes functional capacity in patients and partners at 6 months. The PaTH intervention is innovative because it allows the couple to build new habits together so they can motivate and support one another on their journey toward health, it uses an existing, well-established treatment method (cardiac rehab) to deliver cost-effective care (Balady et al., 2007), it provides self-efficacy and social support for both members of the dyad in making behavioral changes, and no other studies testing the effects of including the partner in CR were found.
- Conditions
- Coronary Heart Disease, Cardiac Rehabilitation
- Being tested
- Partners Together in Health (PaTH) Intervention
- Keywords
- coronary heart disease, cardiac rehabilitation, lifestyle change, coronary artery bypass graft, social support, social cognitive learning theory
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partners Together in Health (PaTH) InterventionBehavioural
Patients and partners in the PaTH experimental group participated in 18-36 exercise and 18 educational sessions in a structured cardiac rehabilitation program. Patients in the Usual care group also participated in 18-36 exercise and 18 educational sessions; partners, however, only participated in the educational sessions.
| Study group | Role | What they receive |
|---|---|---|
| PaTH intervention group | Experimental | The PaTH intervention group for patients and partners consisted of participation in a structured and formal cardiac rehabilitation program:
* 18-36 exercise sessions
* 18 educational sessions. The intervention consisted of patients and partners participating together in a formal cardiac rehabilitation program when typically just patients participate. In addition, partners were asked to make the same healthy eating and exercise changes that patients did to meet guidelines for health. Receives: Behavioral: Partners Together in Health (PaTH) Intervention |
| Usual care group | Active comparator | The usual care group intervention for patients only consisted of participation in a structured and formal cardiac rehabilitation program:
* 18-36 exercise sessions and 18 educational sessions
Partners participated in the 18 educational sessions only. Receives: Behavioral: Partners Together in Health (PaTH) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients
Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.
Measured: 6 months post enrollment/baseline
Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners
Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.
Measured: 6 months post enrollment/baseline
Eating Behavior (% Saturated Fat) in Patients
Eating behavior (% saturated fat) was measured using a 3-day food record.
Measured: 6 months post baseline
Eating Behavior (% Saturated Fat) in Partners
Eating behavior (% saturated fat) was measured using a 3-day food record.
Measured: 6 months post baseline
Secondary outcomes (2)
Functional Capacity in Patients
Exercise tolerance test using a treadmill
Measured: 6 months post baseline
Functional Capacity in Partners
Exercise tolerance test using a treadmill
Measured: 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study start1 Jul 2009
- Primary completion1 Jun 2012
- Study completion1 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients and partners in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of 18-36 exercise and 18 educational sessions. In the usual care group, only patients received the exercise and educational sessions; partners received the educational sessions only.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Bernice C Yates, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926848
- Sponsor's protocol ID
- 0544-08-FB
- Other IDs
- 1R15NR010923-01A1
- Acronym
- PaTH
- Status last verified
- Sep 2023
- First submitted
- 22 Jun 2009
- Last updated
- 25 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Risk in Cardiac Rehabilitation: Partners Together in Health (PaTH) Intervention Study
- ClinicalTrials.gov ID
- NCT00926848
- Acronym / sponsor ID
- PaTH / 0544-08-FB
- Conditions
- Coronary Heart Disease, Cardiac Rehabilitation
- Keywords
- coronary heart disease, cardiac rehabilitation, lifestyle change, coronary artery bypass graft, social support, social cognitive learning theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Jul 2009 (actual)
- Primary completion
- 1 Jun 2012 (actual)
- Study completion
- 1 Jun 2012 (actual)
- First posted
- 24 Jun 2009 (estimated)
- Results
- Posted 20 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the proposed study, using an experimental, two-group (n = 30 couples in each group) repeated measures design, was to pilot test the effects of the PaTH Intervention versus a usual care group in improving the following outcomes: a) physical activity and healthy eating behaviors, and b) functional capacity. The primary outcomes will be physical activity behavior (minutes per week) and eating behavior (percent saturated fat) at the 6 month time point in both the coronary artery bypass graft (CABG) patient and his/her partner. Secondary outcome includes functional capacity in patients and partners at 6 months.
Detailed description
Long-term maintenance of lifestyle changes to reduce cardiovascular risk factors after coronary artery bypass graft (CABG) surgery is essential to positively influence health outcomes. Despite proven efficacy of cardiac rehabilitation (CR) in helping patients initiate lifestyle changes, less than 50% of CABG patients maintain lifestyle changes by 6 months post-CABG. It is known that the spouse is the main source of social support for the recovering cardiac patient and frequently attends cardiac rehabilitation with the patient to provide transportation, emotional support, or attend educational classes. In spite of these supportive behaviors, however; adherence still drops off after CR. Lifestyle interventions that specifically target the marital partners as a unit may be more efficacious than current individually-oriented education strategies. The objective of the proposed feasibility study, using an experimental, two-group (n = 30 couples in each group) repeated measures design, will be to pilot test the effects of the Partners Together in Health (PaTH) Intervention versus usual care in improving physical activity and healthy eating behaviors, and functional capacity. The specific aims are to assess the feasibility of implementing the PaTH Intervention and generate pilot data on all outcome variables in both the CABG patient and the partner to estimate effect sizes needed to determine the sample size requirements for the larger study. Partners in the PaTH Intervention group will formally join CR with the patient to participate in exercise sessions and educational classes to undertake comprehensive risk reduction for themselves, and to make the same positive physical activity/exercise and healthy eating lifestyle changes as the patient. Partners in the usual care group will be invited to attend the educational sessions with the patient as is currently usual care. The primary outcomes will be physical activity behavior (minutes per week) and eating behavior (percent saturated fat) at the 6 month time point in both the coronary artery bypass graft (CABG) patient and his/her partner. The secondary outcome includes functional capacity in patients and partners at 6 months. The PaTH intervention is innovative because it allows the couple to build new habits together so they can motivate and support one another on their journey toward health, it uses an existing, well-established treatment method (cardiac rehab) to deliver cost-effective care (Balady et al., 2007), it provides self-efficacy and social support for both members of the dyad in making behavioral changes, and no other studies testing the effects of including the partner in CR were found.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients and partners in the PaTH intervention group formally joined and participated in the full cardiac rehabilitation (CR) program consisting of 18-36 exercise and 18 educational sessions. In the usual care group, only patients received the exercise and educational sessions; partners received the educational sessions only.
| Arm | Type | Receives |
|---|---|---|
| PaTH intervention group | Experimental | Behavioral: Partners Together in Health (PaTH) InterventionThe PaTH intervention group for patients and partners consisted of participation in a structured and formal cardiac rehabilitation program: * 18-36 exercise sessions * 18 educational sessions. The intervention consisted of patients and partners participating together in a formal cardiac rehabilitation program when typically just patients participate. In addition, partners were asked to make the same healthy eating and exercise changes that patients did to meet guidelines for health. |
| Usual care group | Active comparator | Behavioral: Partners Together in Health (PaTH) InterventionThe usual care group intervention for patients only consisted of participation in a structured and formal cardiac rehabilitation program: * 18-36 exercise sessions and 18 educational sessions Partners participated in the 18 educational sessions only. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- age 19 or older
- diagnosis of first-time coronary artery bypass graft surgery (CABGs) and enrollment in outpatient CR
- married or living with partner for more than 1 year
- partner is also willing to participate
- no history of psychiatric illness
Key exclusion criteria (7 listed)
- orthopedic problems that would prevent them from walking or exercising
- history of cardiac arrest, sudden death, complex dysrhythmias at rest, or CHF diagnosis
- resting systolic BP > 200 mmHg or diastolic BP > 100 mmHg
- a concomitant diagnosis or procedure such as valve repair/replacement or aneurysmectomy
- debilitating non-cardiac disease such as renal failure or anemia
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 |
|---|---|---|
| Partners Together in Health (PaTH) InterventionPatients and partners in the PaTH experimental group participated in 18-36 exercise and 18 educational sessions in a structured cardiac rehabilitation program. Patients in the Usual care group also participated in 18-36 exercise and 18 educational sessions; partners, however, only participated in the educational sessions. | Behavioural | PaTH intervention group, Usual care group |
Primary outcome
Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients
Time frame: 6 months post enrollment/baseline
Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.
Healthy Lifestyle Behavior Was Physical Activity/Exercise in Partners
Time frame: 6 months post enrollment/baseline
Physical activity/exercise behavior was measured using an Actigraph accelerometer at 6 months.
Eating Behavior (% Saturated Fat) in Patients
Time frame: 6 months post baseline
Eating behavior (% saturated fat) was measured using a 3-day food record.
Eating Behavior (% Saturated Fat) in Partners
Time frame: 6 months post baseline
Eating behavior (% saturated fat) was measured using a 3-day food record.
2 secondary outcomes
Functional Capacity in Patients
Time frame: 6 months post baseline
Functional Capacity in Partners
Time frame: 6 months post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bernice C Yates, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partners Together in Health (PaTH) Intervention in people with Coronary Heart Disease and Cardiac Rehabilitation, run by University of Nebraska 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 12 inclusion and 7 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 25 Sep 2023. 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?
Yes. Results are posted in the registry (first posted 20 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Healthy Lifestyle Behavior Was Physical Activity/Exercise in Patients (time frame: 6 months post enrollment/baseline). 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 25 Sep 2023.