Cardiac Rehabilitation, Cardiovascular Diseases, Transition of Care
Conditions
Brief summary
Modified Application of Cardiac Rehabilitation for Older Adults (MACRO) responds to a critical underuse of cardiac rehabilitation in older adults with a coaching model that addresses issues related to aging as a means to better facilitate cardiac rehabilitation (CR). MACRO is a randomized controlled trial (RCT) in which older adults with a CVD event are randomized between a MACRO intervention (MACRO-I) versus usual care. The MACRO-I is designed to facilitate CR as a means to augment functional recovery.
Detailed description
This is a pragmatic RCT of 350 older adults eligible for CR: hospitalized adults aged ≥70 years with a primary diagnosis of acute myocardial infarction/ acute coronary syndrome, stable ischemic heart disease, revascularization (coronary artery bypass graft surgery, percutaneous coronary intervention), valvular heart disease (surgical or transcatheter valve replacement or repair), heart failure (with reduced or preserved ejection fraction) or peripheral arterial disease. Participants who consent to participate will be randomly assigned to a MACRO-intervention (MACRO-I) versus usual care. In the MACRO-I arm, participants receive coaching that incorporates innovative features designed to address needs of older adults. These include holistic risk assessment (medical, functional, psychosocial), guidance to facilitate CR in a format that aligns with each patient's own risks as well as their preferences (i.e., CR formatted as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral reinforcements to promote CR based on their goals of care, and deprescribing of sedating medications. While usual care may include CR, it provides no coaching, and none of the innovations associated with MACRO-I coaching. Endpoints focus particularly on functional capacity achieved by improved implementation of CR. Aim 1: To establish efficacy, safety, and acceptability of the MACRO-I via a RCT. We hypothesize that after 3 months, compared to usual care, participants randomized into MACRO-I will have: H1.1: Greater improvements in function as measured by Activity Measure for Post-Acute Care Computer Adaptive Test (AM-PAC-CAT) Basic Mobility Domain (3 month changes; primary outcome). H1.2: Greater improvements in function as measured by AM-PAC CAT daily activity domain; accelerometry; depression; frailty; self-efficacy; quality of life. H1.3: Greater CR participation and adherence. H1.4: Greater impact on readmissions and hospitalization. Aim 2: To examine the durability of benefit of MACRO-I compared to usual care. We hypothesize that after 6 and 12 months (12 months will be captured as timing allows), compared to usual care, participants randomized into MACRO-I will have: H2.1: Greater improvement in AM-PAC-CAT basic mobility and daily activity domains; accelerometry; depression; frailty; self-efficacy; quality of life. H2.2: Greater impact in readmissions and hospitalization at 6 and 12 months (12 months will be captured as timing allows). Aim 3: To explore characteristics of patients who benefit the most from the MACRO-I as compared to usual care. H3.1: We anticipate functional capacity and other baseline characteristics will identify those who benefit from the MACRO-I (exploratory). The MACRO study originally began recruitment with a target sample size of N=480 in November 2019. The primary outcome measure at this time was the Short Physical Performance Battery (SPPB), and a battery of secondary outcome measures included assessments of hand grip strength, accelerometry, cognition, depression, health literacy, frailty, physical activity, nutrition, readiness for change, self efficacy, and quality of life. However, the COVID-19 pandemic disrupted the original MACRO protocol. In March 2020 per Data Safety and Monitoring Board (DSMB) decision, all study participants who were enrolled at that time were withdrawn and the study was suspended to address safety concerns of face-to-face assessments during the height of the pandemic. It was necessary to modify the protocol so it could administered fully remotely, without changing the original aims and innovation of the intervention. The SPPB was no longer feasible or safe as a primary outcome measure, so the study team selected the Activity Measure for Post-Acute Care with Computerized Adaptive Testing (AM-PAC CAT). The AM-PAC CAT is used to measure self-reported daily activity, can reliably be used to detect change over time, and can be administered over the phone. It was determined that with this new outcome measure, a target sample size of N=374 would be sufficient to retain the same statistical power for the new primary outcome as the original protocol, assuming 80% retention. The secondary outcome assessments were also revised, changing to measures that could be administered remotely when needed and leaving in-person assessments optional contingent on COVID risk. Following all regulatory approvals of the revised protocol and outcome measures, the study restarted recruitment in September 2020. Enrollment concluded in August 2023 after 416 participants had been consented and 350 randomized. The retention rate was higher than anticipated at 87.7% completion of the primary outcome measure at 3 months, which allowed for the same amount of power with a smaller sample size.
Interventions
BEHAVIORALMACRO-I
MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications.
OTHERUsual Care
Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm.
Sponsors
Daniel Forman, MD
National Institute on Aging (NIA)
Washington University School of Medicine
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Key investigators and well as the outcomes assessor at each site will remain blinded to participant group placement.
Intervention model description
There will be two intervention groups 1) MACRO-I in which the research team will work with the participant and providers to facilitate CR; 2) Usual care as determined by their clinical providers.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥70 year * Eligible cardiovascular disease (CVD) diagnosis (hospitalization for acute myocardial infarction/ acute coronary syndrome, stable ischemic heart disease, revascularization (coronary artery bypass graft surgery and percutaneous coronary intervention, valvular heart disease (surgical or transcatheter replacements or repair for mitral regurgitation or aortic stenosis),heart failure (exacerbation or new diagnosis) * English speaking * Able to provide written informed consent * Able to be assessed and undergo study interventions
Exclusion criteria
* Unstable medical condition as indicated by history, physical exam, and/or laboratory findings * Presence of non-CVD conditions likely to be fatal within 12 months (e.g., metastatic cancer) * Severe cognitive impairment: Short Blessed screening with a score of 13 or greater cannot consent (as indicated by medical record) * Long-term care resident at admission with no plans to return to independent living * Unable to participate in follow-up assessments by telephone or in person
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AM-PAC-CAT - Basic Mobility Domain | 3 months, i.e., Baseline to 3-month change | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AM-PAC-CAT - Basic Mobility Domain | Baseline to 6-month change | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations. |
| AM-PAC-CAT - Daily Activity Domain | Baseline to 3-month change | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations. |
| Accelerometry | Baseline to 3-month change | Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume. |
| PATIENT HEALTH QUESTIONNAIRE (PHQ-9) | Baseline to 3-month change | The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression. |
| Morley Frail Scale | Baseline to 3-month change | The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty. |
| Sullivan Cardiac Self-Efficacy | Baseline to 3-month change | The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence. |
| THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score | Baseline to 3-month change | The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively. |
| THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score | Baseline to 3-month change | RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status. |
| Cardiac Rehabilitation Participation | 3 months | Participants will be asked about participation and adherence in cardiac rehabilitation as well as participants' medical records to evaluate utilization of cardiac rehab. Participation is measured as the number of sessions attended which ranges from 0 to 36. It is assumed that more sessions attended is better. |
| Hospitalizations | 12 months | Participants will be asked about hospitalizations during blinded monthly calls and follow-up assessments. Participants' medical records may also be reviewed to evaluate readmission to the hospital. Rate of hospitalizations per person year will be reported by group. It is assumed that a lower number of hospitalizations is better. |
| Duke Activity Status Index (DASI) | Baseline to 3-month Change | The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity. |
| Rapid Eating Assessment for Participants (Modified REAP-S) | Baseline to 3-month Change | The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument. |
| Readiness for Change | Baseline | Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint. An increased readiness for change is associated with greater likelihood of goal attainment. |
| Fall Assessment | 12 months | Falls are a common, deleterious, and expensive aspect of aging which may be preventable via the tenets of MACRO such as good transitional care, age-appropriate exercise, and de-prescribing. We will measure falls as follows: at baseline, we will ask, "Have you had any falls in the past 3 months?" In follow-up assessments, we will ask about interim falls, as well as their severity (e.g., if they caused injury). For the outcome assessment, the count of participants in each group who reported having at least one fall over the 12 month period following randomization is reported. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel E Forman
University of Pittsburgh
Participant flow
Recruitment details
The original recruitment target was 480 beginning in November 2019. Due to the COVID-19 pandemic, the DSMB recommended suspension and withdrawal of all enrolled subjects in March 2020. The protocol was revised to be fully remote, and recruitment was reinitiated with a smaller target sample in September 2020. Enrollment ended in August 2023. 416 subjects consented to the study (total enrolled), and 350 completed the required baseline assessments to be randomized to an intervention group.
Pre-assignment details
After informed consent, subjects completed a set of baseline questionnaires. Participants who did not meet the score requirements on the Short Blessed cognitive assessment at baseline were disqualified before randomization. Other reasons for withdrawal prior to randomization assignment included subject-initiated withdrawal, adverse event, death, or loss to follow-up after discharge from inpatient hospital admission. Participants must have completed baseline assessments in order to be randomized.
Participants by arm
| Arm | Count |
|---|---|
| MACRO-I A coaching intervention that supplements usual care.
MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format \[site transitioning to home\]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications. | 176 |
| Usual Care Care after an acute heart event will be at the discretion of the participants' clinical providers.
Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm. | 174 |
| Total | 350 |
Baseline characteristics
| Characteristic | MACRO-I | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 75.9 years STANDARD_DEVIATION 4.9 | 76.4 years STANDARD_DEVIATION 5.7 | 76.1 years STANDARD_DEVIATION 5.3 |
| AM-PAC CAT Basic Mobility | 57.3 score on a scale STANDARD_DEVIATION 6.5 | 56.3 score on a scale STANDARD_DEVIATION 7.4 | 56.8 score on a scale STANDARD_DEVIATION 7 |
| AM-PAC CAT Daily Activity | 54.6 score on a scale STANDARD_DEVIATION 8.6 | 55.2 score on a scale STANDARD_DEVIATION 9.1 | 54.9 score on a scale STANDARD_DEVIATION 8.8 |
| Average total active time/24 hours (minutes) | 324.1 minutes/24 hours STANDARD_DEVIATION 127.4 | 347.8 minutes/24 hours STANDARD_DEVIATION 130 | 335.0 minutes/24 hours STANDARD_DEVIATION 128.8 |
| Duke Activity Status Index | 25.3 score on a scale STANDARD_DEVIATION 15.7 | 25.6 score on a scale STANDARD_DEVIATION 16.5 | 25.4 score on a scale STANDARD_DEVIATION 16.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 173 Participants | 171 Participants | 344 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Fall History | 33 Participants | 34 Participants | 67 Participants |
| Marital Status Divorced or separated | 26 Participants | 23 Participants | 49 Participants |
| Marital Status In a relationship | 2 Participants | 1 Participants | 3 Participants |
| Marital Status Married or permanent partnership | 95 Participants | 102 Participants | 197 Participants |
| Marital Status Never married | 10 Participants | 10 Participants | 20 Participants |
| Marital Status Other | 1 Participants | 1 Participants | 2 Participants |
| Marital Status Widowed | 42 Participants | 37 Participants | 79 Participants |
| Modified Rapid Eating Assessment for Participants-Shortened Version | 31.1 score on a scale STANDARD_DEVIATION 3.9 | 31.4 score on a scale STANDARD_DEVIATION 4.3 | 31.2 score on a scale STANDARD_DEVIATION 4.1 |
| Morley Frail Scale | 2.3 score on a scale STANDARD_DEVIATION 1.4 | 2.2 score on a scale STANDARD_DEVIATION 1.4 | 2.2 score on a scale STANDARD_DEVIATION 1.4 |
| Patient Health Questionnaire-9 | 4.7 score on a scale STANDARD_DEVIATION 3.1 | 4.9 score on a scale STANDARD_DEVIATION 2.8 | 4.8 score on a scale STANDARD_DEVIATION 3 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 21 Participants | 39 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 155 Participants | 152 Participants | 307 Participants |
| Region of Enrollment United States | 176 participants | 174 participants | 350 participants |
| Sex: Female, Male Female | 50 Participants | 58 Participants | 108 Participants |
| Sex: Female, Male Male | 126 Participants | 116 Participants | 242 Participants |
| Social Support Lives alone | 69 Participants | 50 Participants | 119 Participants |
| Social Support Lives with others | 107 Participants | 124 Participants | 231 Participants |
| Sullivan Cardiac Self Efficacy | 34.8 score on a scale STANDARD_DEVIATION 7.6 | 35.0 score on a scale STANDARD_DEVIATION 7.2 | 34.9 score on a scale STANDARD_DEVIATION 7.4 |
| Veterans RAND-12 Mental Summary Score | 50.0 score on a scale STANDARD_DEVIATION 10 | 49.8 score on a scale STANDARD_DEVIATION 8.9 | 49.9 score on a scale STANDARD_DEVIATION 9.5 |
| Veterans RAND-12 Physical Summary Score | 28.6 score on a scale STANDARD_DEVIATION 10.1 | 28.5 score on a scale STANDARD_DEVIATION 10.4 | 28.5 score on a scale STANDARD_DEVIATION 10.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 176 | 12 / 174 |
| other Total, other adverse events | 103 / 176 | 93 / 174 |
| serious Total, serious adverse events | 74 / 176 | 70 / 174 |
Outcome results
Primary
AM-PAC-CAT - Basic Mobility Domain
AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations.
Time frame: 3 months, i.e., Baseline to 3-month change
Population: All 350 randomized participants were analyzed with multiple imputation (Markov Chain Monte Carlo or MCMC method) for any missing or incomplete outcomes data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | AM-PAC-CAT - Basic Mobility Domain | 5.1 score on a scale | Standard Deviation 7.5 |
| Usual Care | AM-PAC-CAT - Basic Mobility Domain | 5.0 score on a scale | Standard Deviation 5.4 |
p-value: 0.543Mixed Models Analysis
Secondary
Accelerometry
Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume.
Time frame: Baseline to 6-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Accelerometry | 34.0 minutes/24 hours | Standard Deviation 100.8 |
| Usual Care | Accelerometry | 18.3 minutes/24 hours | Standard Deviation 127.4 |
p-value: 0.6588Mixed Models Analysis
Secondary
Accelerometry
Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume.
Time frame: Baseline to 12-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Accelerometry | 44.8 minutes/24 hours | Standard Deviation 121.6 |
| Usual Care | Accelerometry | 12.9 minutes/24 hours | Standard Deviation 119.1 |
p-value: 0.992Mixed Models Analysis
Secondary
Accelerometry
Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume.
Time frame: Baseline to 3-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Accelerometry | 37.3 minutes/24 hours | Standard Deviation 95.8 |
| Usual Care | Accelerometry | 13.9 minutes/24 hours | Standard Deviation 115.4 |
p-value: 0.9257Mixed Models Analysis
Secondary
AM-PAC-CAT - Basic Mobility Domain
AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations.
Time frame: Baseline to 6-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | AM-PAC-CAT - Basic Mobility Domain | 4.9 score on a scale | Standard Deviation 6.7 |
| Usual Care | AM-PAC-CAT - Basic Mobility Domain | 5.2 score on a scale | Standard Deviation 5.9 |
p-value: 0.7625Mixed Models Analysis
Secondary
AM-PAC-CAT - Basic Mobility Domain
AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations.
Time frame: Baseline to 12-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | AM-PAC-CAT - Basic Mobility Domain | 4.9 score on a scale | Standard Deviation 7.3 |
| Usual Care | AM-PAC-CAT - Basic Mobility Domain | 5.3 score on a scale | Standard Deviation 6.5 |
p-value: 0.8842Mixed Models Analysis
Secondary
AM-PAC-CAT - Daily Activity Domain
AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations.
Time frame: Baseline to 6-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | AM-PAC-CAT - Daily Activity Domain | 6.3 score on a scale | Standard Deviation 10 |
| Usual Care | AM-PAC-CAT - Daily Activity Domain | 5.2 score on a scale | Standard Deviation 10.6 |
p-value: 0.3841Mixed Models Analysis
Secondary
AM-PAC-CAT - Daily Activity Domain
AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations.
Time frame: Baseline to 3-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | AM-PAC-CAT - Daily Activity Domain | 5.8 score on a scale | Standard Deviation 8.8 |
| Usual Care | AM-PAC-CAT - Daily Activity Domain | 4.5 score on a scale | Standard Deviation 11.1 |
p-value: 0.4086Mixed Models Analysis
Secondary
AM-PAC-CAT - Daily Activity Domain
AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations.
Time frame: Baseline to 12-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | AM-PAC-CAT - Daily Activity Domain | 6.9 score on a scale | Standard Deviation 11.2 |
| Usual Care | AM-PAC-CAT - Daily Activity Domain | 5.1 score on a scale | Standard Deviation 11.3 |
p-value: 0.1393Mixed Models Analysis
Secondary
Cardiac Rehabilitation Participation
Participants will be asked about participation and adherence in cardiac rehabilitation as well as participants' medical records to evaluate utilization of cardiac rehab. Participation is measured as the number of sessions attended which ranges from 0 to 36. It is assumed that more sessions attended is better.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Cardiac Rehabilitation Participation | 10.1 number of sessions attended | Standard Deviation 12 |
| Usual Care | Cardiac Rehabilitation Participation | 10.6 number of sessions attended | Standard Deviation 12.6 |
p-value: 0.7651Wilcoxon rank sum
Secondary
Duke Activity Status Index (DASI)
The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity.
Time frame: Baseline to 12-month Change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Duke Activity Status Index (DASI) | 9.1 score on a scale | Standard Deviation 15.6 |
| Usual Care | Duke Activity Status Index (DASI) | 8.0 score on a scale | Standard Deviation 15.9 |
p-value: 0.4354Mixed Models Analysis
Secondary
Duke Activity Status Index (DASI)
The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity.
Time frame: Baseline to 6-month Change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Duke Activity Status Index (DASI) | 8.5 score on a scale | Standard Deviation 15.9 |
| Usual Care | Duke Activity Status Index (DASI) | 7.7 score on a scale | Standard Deviation 13.7 |
p-value: 0.4269Mixed Models Analysis
Secondary
Duke Activity Status Index (DASI)
The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity.
Time frame: Baseline to 3-month Change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Duke Activity Status Index (DASI) | 10.1 score on a scale | Standard Deviation 15.4 |
| Usual Care | Duke Activity Status Index (DASI) | 7.1 score on a scale | Standard Deviation 14.2 |
p-value: 0.2727Mixed Models Analysis
Secondary
Fall Assessment
Falls are a common, deleterious, and expensive aspect of aging which may be preventable via the tenets of MACRO such as good transitional care, age-appropriate exercise, and de-prescribing. We will measure falls as follows: at baseline, we will ask, Have you had any falls in the past 3 months? In follow-up assessments, we will ask about interim falls, as well as their severity (e.g., if they caused injury). For the outcome assessment, the count of participants in each group who reported having at least one fall over the 12 month period following randomization is reported.
Time frame: 12 months
Population: 158 participants in the MACRO-i arm and 153 in Usual Care completed the fall assessment at follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MACRO-I | Fall Assessment | 52 Participants |
| Usual Care | Fall Assessment | 50 Participants |
p-value: 0.965395% CI: [0.63, 1.62]Regression, Logistic
Secondary
Hospitalizations
Participants will be asked about hospitalizations during blinded monthly calls and follow-up assessments. Participants' medical records may also be reviewed to evaluate readmission to the hospital. Rate of hospitalizations per person year will be reported by group. It is assumed that a lower number of hospitalizations is better.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MACRO-I | Hospitalizations | 0.69 events per person year |
| Usual Care | Hospitalizations | 0.60 events per person year |
p-value: 0.397495% CI: [0.83, 1.59]Negative binomial regression models
Secondary
Morley Frail Scale
The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty.
Time frame: Baseline to 12-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Morley Frail Scale | -0.6 score on a scale | Standard Deviation 1.3 |
| Usual Care | Morley Frail Scale | -0.4 score on a scale | Standard Deviation 1.5 |
p-value: 0.1194Mixed Models Analysis
Secondary
Morley Frail Scale
The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty.
Time frame: Baseline to 6-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Morley Frail Scale | -0.4 score on a scale | Standard Deviation 1.3 |
| Usual Care | Morley Frail Scale | -0.5 score on a scale | Standard Deviation 1.4 |
p-value: 0.5553Mixed Models Analysis
Secondary
Morley Frail Scale
The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty.
Time frame: Baseline to 3-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Morley Frail Scale | -0.5 score on a scale | Standard Deviation 1.3 |
| Usual Care | Morley Frail Scale | -0.4 score on a scale | Standard Deviation 1.3 |
p-value: 0.5071Mixed Models Analysis
Secondary
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression.
Time frame: Baseline to 6-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | PATIENT HEALTH QUESTIONNAIRE (PHQ-9) | -1.9 score on a scale | Standard Deviation 3.5 |
| Usual Care | PATIENT HEALTH QUESTIONNAIRE (PHQ-9) | -2.2 score on a scale | Standard Deviation 2.8 |
p-value: 0.6228Mixed Models Analysis
Secondary
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression.
Time frame: Baseline to 3-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | PATIENT HEALTH QUESTIONNAIRE (PHQ-9) | -2.1 score on a scale | Standard Deviation 3.1 |
| Usual Care | PATIENT HEALTH QUESTIONNAIRE (PHQ-9) | -2.2 score on a scale | Standard Deviation 2.9 |
p-value: 0.9504Mixed Models Analysis
Secondary
PATIENT HEALTH QUESTIONNAIRE (PHQ-9)
The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression.
Time frame: Baseline to 12-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | PATIENT HEALTH QUESTIONNAIRE (PHQ-9) | -1.7 score on a scale | Standard Deviation 3 |
| Usual Care | PATIENT HEALTH QUESTIONNAIRE (PHQ-9) | -2.3 score on a scale | Standard Deviation 3 |
p-value: 0.7966Mixed Models Analysis
Secondary
Rapid Eating Assessment for Participants (Modified REAP-S)
The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument.
Time frame: Baseline to 6-month Change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Rapid Eating Assessment for Participants (Modified REAP-S) | 3.1 score on a scale | Standard Deviation 3.4 |
| Usual Care | Rapid Eating Assessment for Participants (Modified REAP-S) | 2.9 score on a scale | Standard Deviation 3.8 |
p-value: 0.7075Mixed Models Analysis
Secondary
Rapid Eating Assessment for Participants (Modified REAP-S)
The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument.
Time frame: Baseline to 3-month Change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Rapid Eating Assessment for Participants (Modified REAP-S) | 2.8 score on a scale | Standard Deviation 3.4 |
| Usual Care | Rapid Eating Assessment for Participants (Modified REAP-S) | 2.7 score on a scale | Standard Deviation 3.9 |
p-value: 0.8695Mixed Models Analysis
Secondary
Rapid Eating Assessment for Participants (Modified REAP-S)
The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument.
Time frame: Baseline to 12-month Change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Rapid Eating Assessment for Participants (Modified REAP-S) | 3.1 score on a scale | Standard Deviation 3.3 |
| Usual Care | Rapid Eating Assessment for Participants (Modified REAP-S) | 3.0 score on a scale | Standard Deviation 3.8 |
p-value: 0.8936Mixed Models Analysis
Secondary
Readiness for Change
Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline Are you ready to make some healthy lifestyle changes to help your heart?, and at each follow-up assessment Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart? to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint.
Time frame: 3 Months
Population: 153 participants in the MACRO-I arm and 150 in the Usual Care arm completed the Readiness for Change at the 3 month time point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MACRO-I | Readiness for Change | Contemplation | 8 Participants |
| MACRO-I | Readiness for Change | Action | 102 Participants |
| MACRO-I | Readiness for Change | Preparation | 9 Participants |
| MACRO-I | Readiness for Change | Maintenance | 32 Participants |
| MACRO-I | Readiness for Change | Precontemplation | 2 Participants |
| Usual Care | Readiness for Change | Maintenance | 37 Participants |
| Usual Care | Readiness for Change | Precontemplation | 3 Participants |
| Usual Care | Readiness for Change | Contemplation | 8 Participants |
| Usual Care | Readiness for Change | Preparation | 14 Participants |
| Usual Care | Readiness for Change | Action | 88 Participants |
p-value: 0.6177Chi-squared
Secondary
Readiness for Change
Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline Are you ready to make some healthy lifestyle changes to help your heart?, and at each follow-up assessment Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart? to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint.
Time frame: 12 Months
Population: 137 participants in the MACRO-I arm and 129 in the Usual Care arm completed the Readiness for Change at the 12 month assessment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MACRO-I | Readiness for Change | Contemplation | 4 Participants |
| MACRO-I | Readiness for Change | Action | 34 Participants |
| MACRO-I | Readiness for Change | Preparation | 10 Participants |
| MACRO-I | Readiness for Change | Maintenance | 81 Participants |
| MACRO-I | Readiness for Change | Precontemplation | 8 Participants |
| Usual Care | Readiness for Change | Maintenance | 66 Participants |
| Usual Care | Readiness for Change | Precontemplation | 2 Participants |
| Usual Care | Readiness for Change | Contemplation | 9 Participants |
| Usual Care | Readiness for Change | Preparation | 12 Participants |
| Usual Care | Readiness for Change | Action | 40 Participants |
p-value: 0.1122Chi-squared
Secondary
Readiness for Change
Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline Are you ready to make some healthy lifestyle changes to help your heart?, and at each follow-up assessment Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart? to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint. An increased readiness for change is associated with greater likelihood of goal attainment.
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MACRO-I | Readiness for Change | Contemplation | 40 Participants |
| MACRO-I | Readiness for Change | Action | 65 Participants |
| MACRO-I | Readiness for Change | Preparation | 60 Participants |
| MACRO-I | Readiness for Change | Maintenance | 7 Participants |
| MACRO-I | Readiness for Change | Precontemplation | 4 Participants |
| Usual Care | Readiness for Change | Maintenance | 1 Participants |
| Usual Care | Readiness for Change | Precontemplation | 5 Participants |
| Usual Care | Readiness for Change | Contemplation | 43 Participants |
| Usual Care | Readiness for Change | Preparation | 55 Participants |
| Usual Care | Readiness for Change | Action | 70 Participants |
p-value: 0.2794Chi-squared
Secondary
Readiness for Change
Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline Are you ready to make some healthy lifestyle changes to help your heart?, and at each follow-up assessment Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart? to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint.
Time frame: 6 Months
Population: 144 participants in the MACRO-I arm and 137 in the Usual Care arm completed the Readiness for Change at the 6 month assessment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MACRO-I | Readiness for Change | Precontemplation | 5 Participants |
| MACRO-I | Readiness for Change | Action | 51 Participants |
| MACRO-I | Readiness for Change | Preparation | 9 Participants |
| MACRO-I | Readiness for Change | Maintenance | 74 Participants |
| MACRO-I | Readiness for Change | Contemplation | 5 Participants |
| Usual Care | Readiness for Change | Maintenance | 56 Participants |
| Usual Care | Readiness for Change | Precontemplation | 2 Participants |
| Usual Care | Readiness for Change | Contemplation | 6 Participants |
| Usual Care | Readiness for Change | Preparation | 18 Participants |
| Usual Care | Readiness for Change | Action | 55 Participants |
p-value: 0.144Chi-squared
Secondary
Sullivan Cardiac Self-Efficacy
The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence.
Time frame: Baseline to 12-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Sullivan Cardiac Self-Efficacy | 2.7 score on a scale | Standard Deviation 8.5 |
| Usual Care | Sullivan Cardiac Self-Efficacy | 1.3 score on a scale | Standard Deviation 8.7 |
p-value: 0.1932Mixed Models Analysis
Secondary
Sullivan Cardiac Self-Efficacy
The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence.
Time frame: Baseline to 3-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Sullivan Cardiac Self-Efficacy | 3.2 score on a scale | Standard Deviation 7.8 |
| Usual Care | Sullivan Cardiac Self-Efficacy | 3.0 score on a scale | Standard Deviation 7.9 |
p-value: 0.9012Mixed Models Analysis
Secondary
Sullivan Cardiac Self-Efficacy
The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence.
Time frame: Baseline to 6-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | Sullivan Cardiac Self-Efficacy | 2.9 score on a scale | Standard Deviation 8.9 |
| Usual Care | Sullivan Cardiac Self-Efficacy | 1.8 score on a scale | Standard Deviation 8.7 |
p-value: 0.4279Mixed Models Analysis
Secondary
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score
RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. These provide an important contrast between physical and psychological health status.
Time frame: Baseline to 6-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score | 4.6 score on a scale | Standard Deviation 9.5 |
| Usual Care | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score | 5.5 score on a scale | Standard Deviation 9.2 |
p-value: 0.614Mixed Models Analysis
Secondary
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score
RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. These provide an important contrast between physical and psychological health status.
Time frame: Baseline to 3-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score | 4.6 score on a scale | Standard Deviation 9.5 |
| Usual Care | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score | 5.5 score on a scale | Standard Deviation 9.2 |
p-value: 0.8307Mixed Models Analysis
Secondary
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score
RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. These provide an important contrast between physical and psychological health status.
Time frame: Baseline to 12-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score | 4.6 score on a scale | Standard Deviation 10.4 |
| Usual Care | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score | 6.4 score on a scale | Standard Deviation 8.2 |
p-value: 0.7327Mixed Models Analysis
Secondary
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score
The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively.
Time frame: Baseline to 12-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score | 7.4 score on a scale | Standard Deviation 11.6 |
| Usual Care | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score | 5.1 score on a scale | Standard Deviation 13.5 |
p-value: 0.2574Mixed Models Analysis
Secondary
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score
The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively.
Time frame: Baseline to 6-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score | 7.1 score on a scale | Standard Deviation 10.8 |
| Usual Care | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score | 7.0 score on a scale | Standard Deviation 11.1 |
p-value: 0.8951Mixed Models Analysis
Secondary
THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score
The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively.
Time frame: Baseline to 3-month change
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MACRO-I | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score | 7.4 score on a scale | Standard Deviation 10.4 |
| Usual Care | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score | 5.6 score on a scale | Standard Deviation 11.8 |
p-value: 0.2723Mixed Models Analysis