Acute Coronary Syndrome, Cardiovascular Diseases, Depression
Conditions
Keywords
Mindfulness, Acute Coronary Syndrome, Videoconferencing, Depression
Brief summary
The aim of this study is to establish, in a pilot RCT (approx. N=50 participants) with a time- and attention-matched health enhancement control, (a) the feasibility of the recruitment procedures (screening, eligibility, enrollment rates), and feasibility and acceptability of the (b) MBCT and control interventions (adherence, retention, fidelity, satisfaction, group videoconferencing delivery) and (c) data collection procedures by group (adherence, satisfaction). Hypothesis 1a: Recruitment will be feasible as evidenced by screening, eligibility, and enrollment rates; (1b) the MBCT and control interventions and (1c) data collection procedures in both groups will be feasible and acceptable.
Detailed description
The current study will employ an open pilot RCT with a time-and-attention-matched health control group to determine the feasibility and acceptability of a virtual, MBCT intervention for ACS patients. The investigators plan to enroll approximately N=50 participants (approx. 3 MBCT groups and approx. 3 health enhancement control groups with approximately 6-7 participants per group; accounting for 20% attrition). Participants will be randomized to a MBCT or a time- and attention-matched health enhancement control in a 1:1 design using a random number generator. Participants will then be stratified by antidepressant medication use. The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will be taught how to use evidence-based mindfulness skills to regulate distress and choose healthy behaviors, as well as learn about cardiac health. The health enhancement control group will follow the same structure of the MBCT intervention (e.g., 8 virtually-delivered MBCT sessions, approximately 1.5 hours each) and will educate participants on depression and cardiac health (e.g., relationship between depression and cardiac health, cardiac risk factors, cardiac health behaviors, finding resources for mental health care). Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes). Participants will be recruited through EPIC, the hospital's clinical data registry, advertisements (e.g., flyers, brochures) placed throughout the hospital, direct provider referrals, and from inpatient cardiac units. Patients who express interest in the study will be asked complete an eligibility screening. Eligible patients agreeable with study participation will then complete informed consent with study staff prior to enrollment. Participants will be enrolled in either one of three MBCT intervention cohorts (approx.) or one of three health enhancement control cohorts (approx.). Participants in all of these groups will be expected to participate in 8-weekly, 1.5-hour virtual sessions. Participants in the MBCT intervention group will be expected to participate in 30 minutes of at-home daily practice. Participants in the health enhancement control group will be expected to review educational videos or readings between sessions. A licensed mental health provider (e.g., LICSW, PhD) trained in the MBCT protocol will delivered the intervention to the MBCT intervention group. A licensed clinician or pre-doctoral or post-doctoral fellow with supervision from a licensed clinician will lead the control group. Both the MBCT intervention and health enhancement control groups will be delivered via Zoom, secure, HIPPA-compliant video-conferencing software. Study assessments will include a battery of self-report surveys administered at baseline, post-intervention, and 3-month follow-up; session satisfaction surveys administered after each intervention session; post-intervention individual exit interviews (conducted via telephone or videoconference); blood spot samples self-collected by participants at baseline, post-intervention, and 3-month follow-up (submitted to the research team via paper mail); and, for the MBCT-intervention group, home practice logs submitted between each intervention session. Primary outcomes for the intervention are feasibility and acceptability. Exploratory outcomes are changes in emotional and biological variables. Data collected from this study will generate knowledge about e-health technologies and congruent research methods to apply to other mind-body interventions and patient populations.
Interventions
BEHAVIORALAdapted MBCT
The adapted MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will be taught how to use evidence-based mindfulness skills to regulate distress and choose healthy behaviors, as well as learn about cardiac health.
BEHAVIORALCardiac Health Enhancement
The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Lifetime ACS per medical record and/or patient confirmation 2. Current elevated depression symptoms (PHQ-9 greater than or equal to 5) 3. Age 35-85 years 4. Access to high-speed internet
Exclusion criteria
1. Active suicidal ideation or past-year psychiatric hospitalization (per patient report and/or medical record review) 2. Non-English-speaking 3. Cognitive impairments preventing informed consent per medical record review and/or cognitive Screen less than or equal to 4 4. Patient deemed unable to complete the study protocol or has a condition that would likely interfere with the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility: Percent of Participants Screened Eligible | 6 months | Feasibility outcomes for recruitment will include: \>70% meet screening criteria |
| Recruitment Feasibility: Percent of Participants Enrolled | 6 months | Feasibility outcomes for recruitment will include: \>70% of eligible enroll |
| MBCT Feasibility: Percent of Participants Retained | 6 months | MBCT intervention feasibility will include: \>75% of participants retained at post-assessment survey |
| Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment | 6 months | MBCT intervention feasibility will include: \>75% of participants attending 6/8 sessions. Adherent to treatment is defined as participants attending 6 out of 8 sessions. |
| Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice | 6 months | MBCT feasibility will include: \>75% complete home practice at least 3 days/week. Adherence was defined as completion of home practice long at least 3 days per week. |
| Control Group Feasibility: Percent of Participants Retained | 6 months | Control group feasibility will include: \>75% of participants retained at post-assessment survey |
| Control Group Feasibility: Percent of Participants Adherent to Treatment | 6 months | Control group feasibility will include: \>75% of participants attending 6/8 sessions sessions. Adherent to treatment is defined as participants attending 6 out of 8 sessions. |
| Control Group Feasibility: Percent of Participants Adherent to Home Practice | 6 months | Control group feasibility will include: \>75% complete home practice at least 3 days/week. Adherent to home practice is defined as participants completing home practice at least 3 days per week. |
| Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems | 6 months | Videoconferencing feasibility will be assessed by: \<20% of sessions missed due to technical problems |
| Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline | At Baseline (Month 0) | Blood spot feasibility will be assessed by \>75% of samples submitted at baseline. Participants contributed one blood spot sample at the specified time point. |
| Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention | At Post Intervention (Month 3) | Blood spot feasibility will be assessed by \>75% of samples submitted at post-intervention |
| Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction | At post intervention (Month 3) | MBCT acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much). Satisfaction will be measured by mean score greater than 7.5 |
| Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills | 6 months | MBCT and acceptability will be assessed by 75% plan to use the skills |
| Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program | 6 months | MBCT and acceptability will be assessed by \>75% of participants reporting that they would recommend the program to others |
| Control Group Acceptability: Ratings of Intervention Satisfaction | 6 months | Control group acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much). Satisfaction will be measured by an overall mean score greater than 7.5. |
| Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills | 6 months | Control group acceptability will be assessed by 75% of participants reporting that they plan to use the skills |
| Control Group Acceptability: Percent of Participants Who Would Recommend the Program | 6 months | Control group acceptability will be assessed by \>75% of participants reporting that they would recommend the program to others |
| Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction | 6 months | Videoconferencing acceptability will be assessed in terms of overall satisfaction (1=poor,10=excellent; M\>7.5) |
| Blood Spot Acceptability: Blood Spot Collection Ease | 6 months | Blood spot acceptability will be assessed by ratings of ease of data collection (1=not at all, 10=extremely). Satisfaction will be measured by an overall mean score greater than 7.5. |
| Blood Spot Acceptability: Blood Spot Collection Comfort | 6 months | Blood spot acceptability will be assessed by ratings of ease of level of pain (1=very much pain, 10=very little pain; M\>8.0). Acceptability will be measured by an overall mean score greater than 8.0. |
Countries
United States
Participant flow
Pre-assignment details
Of 407 participants recruited, 219 were screened. 63 were found ineligible and 108 declined to participate leaving 48 eligible participants. 18 refused to participate so 30 participants were consented to the study. 6 of those 30 consented participants did not complete the baseline survey or withdrew from the study, leaving 24 participants to be randomized into the intervention groups.
Participants by arm
| Arm | Count |
|---|---|
| Virtual Mindfulness Based Cognitive Therapy (MBCT) Intervention Participants will participate in 8 weekly virtual group sessions of MBCT. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes).
Adapted MBCT: The adapted MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will be taught how to use evidence-based mindfulness skills to regulate distress and choose healthy behaviors, as well as learn about cardiac health. | 12 |
| Virtual Health Enhancement Control Participants will participate in 8 weekly virtual group sessions that focus on cardiac health and depression education. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes).
Cardiac Health Enhancement: The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health. | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
Baseline characteristics
| Characteristic | Virtual Mindfulness Based Cognitive Therapy (MBCT) Intervention | Total | Virtual Health Enhancement Control |
|---|---|---|---|
| Age, Continuous | 57.92 years STANDARD_DEVIATION 10.95 | 57.67 years STANDARD_DEVIATION 11.374 | 57.42 years STANDARD_DEVIATION 12.266 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 21 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Patient Health Questionnaire (PHQ-9) | 9.67 score on scale STANDARD_DEVIATION 4.097 | 11.04 score on scale STANDARD_DEVIATION 5.521 | 12.42 score on scale STANDARD_DEVIATION 6.543 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 21 Participants | 12 Participants |
| Sex: Female, Male Female | 5 Participants | 15 Participants | 10 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 2 Participants |
| Time Since Acute Coronary Syndrome (ACS) | 3.38 Years STANDARD_DEVIATION 3.844 | 2.88 Years STANDARD_DEVIATION 2.97 | 2.39 Years STANDARD_DEVIATION 1.77 |
| Type of Acute Coronary Syndrome (ACS) MI & STEMI | 0 Participants | 1 Participants | 1 Participants |
| Type of Acute Coronary Syndrome (ACS) Myocardial infarction (MI) | 1 Participants | 1 Participants | 0 Participants |
| Type of Acute Coronary Syndrome (ACS) Non-ST-elevation myocardial infarction (NSTEMI) | 3 Participants | 8 Participants | 5 Participants |
| Type of Acute Coronary Syndrome (ACS) NSTEMI & STEMI | 1 Participants | 1 Participants | 0 Participants |
| Type of Acute Coronary Syndrome (ACS) NSTEMI & UA & SCAD | 0 Participants | 1 Participants | 1 Participants |
| Type of Acute Coronary Syndrome (ACS) SCAD & NSTEMI | 0 Participants | 1 Participants | 1 Participants |
| Type of Acute Coronary Syndrome (ACS) SCAD & STEMI | 0 Participants | 1 Participants | 1 Participants |
| Type of Acute Coronary Syndrome (ACS) Spontaneous coronary artery dissection (SCAD) | 3 Participants | 6 Participants | 3 Participants |
| Type of Acute Coronary Syndrome (ACS) ST-elevation myocardial infarction (STEMI) | 2 Participants | 2 Participants | 0 Participants |
| Type of Acute Coronary Syndrome (ACS) STEMI & UA | 1 Participants | 1 Participants | 0 Participants |
| Type of Acute Coronary Syndrome (ACS) Unstable Angina (UA) | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Blood Spot Acceptability: Blood Spot Collection Comfort
Blood spot acceptability will be assessed by ratings of ease of level of pain (1=very much pain, 10=very little pain; M\>8.0). Acceptability will be measured by an overall mean score greater than 8.0.
Time frame: 6 months
Population: Participants who answered videoconferencing satisfaction question on post intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screened Participants | Blood Spot Acceptability: Blood Spot Collection Comfort | 9.10 units on a scale | Standard Deviation 1.595 |
| Virtual Health Enhancement Control | Blood Spot Acceptability: Blood Spot Collection Comfort | 9.50 units on a scale | Standard Deviation 1.069 |
Primary
Blood Spot Acceptability: Blood Spot Collection Ease
Blood spot acceptability will be assessed by ratings of ease of data collection (1=not at all, 10=extremely). Satisfaction will be measured by an overall mean score greater than 7.5.
Time frame: 6 months
Population: Participants who answered videoconferencing satisfaction question on post intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screened Participants | Blood Spot Acceptability: Blood Spot Collection Ease | 8.50 units on a scale | Standard Deviation 2.121 |
| Virtual Health Enhancement Control | Blood Spot Acceptability: Blood Spot Collection Ease | 8.38 units on a scale | Standard Deviation 3.159 |
Primary
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline
Blood spot feasibility will be assessed by \>75% of samples submitted at baseline. Participants contributed one blood spot sample at the specified time point.
Time frame: At Baseline (Month 0)
Population: All participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline | 11 Participants |
| Virtual Health Enhancement Control | Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline | 11 Participants |
Primary
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention
Blood spot feasibility will be assessed by \>75% of samples submitted at post-intervention
Time frame: At Post Intervention (Month 3)
Population: All participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention | 8 Participants |
| Virtual Health Enhancement Control | Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention | 7 Participants |
Primary
Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills
Control group acceptability will be assessed by 75% of participants reporting that they plan to use the skills
Time frame: 6 months
Population: Number of participants who answered the relevant survey question on the post-intervention survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills | 8 Participants |
Primary
Control Group Acceptability: Percent of Participants Who Would Recommend the Program
Control group acceptability will be assessed by \>75% of participants reporting that they would recommend the program to others
Time frame: 6 months
Population: Number of participants who answered the relevant survey question on the post-intervention survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Control Group Acceptability: Percent of Participants Who Would Recommend the Program | 8 Participants |
Primary
Control Group Acceptability: Ratings of Intervention Satisfaction
Control group acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much). Satisfaction will be measured by an overall mean score greater than 7.5.
Time frame: 6 months
Population: Number of participants who answered the relevant survey question on the post-intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screened Participants | Control Group Acceptability: Ratings of Intervention Satisfaction | 8.13 score on a scale | Standard Deviation 1.959 |
Primary
Control Group Feasibility: Percent of Participants Adherent to Home Practice
Control group feasibility will include: \>75% complete home practice at least 3 days/week. Adherent to home practice is defined as participants completing home practice at least 3 days per week.
Time frame: 6 months
Population: N = 8 participants completed the post intervention survey. MCBT intervention group was not analyzed for this outcome measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Control Group Feasibility: Percent of Participants Adherent to Home Practice | 4 Participants |
Primary
Control Group Feasibility: Percent of Participants Adherent to Treatment
Control group feasibility will include: \>75% of participants attending 6/8 sessions sessions. Adherent to treatment is defined as participants attending 6 out of 8 sessions.
Time frame: 6 months
Population: MBCT Intervention Group was not analyzed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Control Group Feasibility: Percent of Participants Adherent to Treatment | 8 Participants |
Primary
Control Group Feasibility: Percent of Participants Retained
Control group feasibility will include: \>75% of participants retained at post-assessment survey
Time frame: 6 months
Population: MBCT intervention group was not analyzed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Control Group Feasibility: Percent of Participants Retained | 8 Participants |
Primary
MBCT Feasibility: Percent of Participants Retained
MBCT intervention feasibility will include: \>75% of participants retained at post-assessment survey
Time frame: 6 months
Population: MBCT feasibility outcome only; Control Group was not analyzed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | MBCT Feasibility: Percent of Participants Retained | 10 Participants |
Primary
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills
MBCT and acceptability will be assessed by 75% plan to use the skills
Time frame: 6 months
Population: Participants who answered the relevant survey question on the post intervention survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills | 8 Participants |
Primary
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program
MBCT and acceptability will be assessed by \>75% of participants reporting that they would recommend the program to others
Time frame: 6 months
Population: Number of participants who answered the relevant survey question on the post intervention survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program | 8 Participants |
Primary
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction
MBCT acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much). Satisfaction will be measured by mean score greater than 7.5
Time frame: At post intervention (Month 3)
Population: Participants who answered intervention satisfaction question on post intervention survey. Control Group was not analyzed for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screened Participants | Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction | 8.67 score on a scale | Standard Deviation 2.598 |
Primary
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice
MBCT feasibility will include: \>75% complete home practice at least 3 days/week. Adherence was defined as completion of home practice long at least 3 days per week.
Time frame: 6 months
Population: Participants (n = 10) in the MBCT intervention who completed the post intervention survey. Control group was not analyzed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice | 8 Participants |
Primary
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment
MBCT intervention feasibility will include: \>75% of participants attending 6/8 sessions. Adherent to treatment is defined as participants attending 6 out of 8 sessions.
Time frame: 6 months
Population: MBCT outcome measure only; control group was not analyzed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment | 6 Participants |
Primary
Recruitment Feasibility: Percent of Participants Enrolled
Feasibility outcomes for recruitment will include: \>70% of eligible enroll
Time frame: 6 months
Population: Participants who were deemed eligible in the study screening process.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Recruitment Feasibility: Percent of Participants Enrolled | 24 Participants |
Primary
Recruitment Feasibility: Percent of Participants Screened Eligible
Feasibility outcomes for recruitment will include: \>70% meet screening criteria
Time frame: 6 months
Population: The number of participants who were screened.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screened Participants | Recruitment Feasibility: Percent of Participants Screened Eligible | 48 Participants |
Primary
Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction
Videoconferencing acceptability will be assessed in terms of overall satisfaction (1=poor,10=excellent; M\>7.5)
Time frame: 6 months
Population: Participants who answered intervention satisfaction questions on post intervention survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Screened Participants | Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction | 9.75 Units on a scale | Standard Deviation 0.463 |
| Virtual Health Enhancement Control | Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction | 9.63 Units on a scale | Standard Deviation 1.061 |
Primary
Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems
Videoconferencing feasibility will be assessed by: \<20% of sessions missed due to technical problems
Time frame: 6 months
Population: All participants who were randomized into study groups. Across all groups/arm, there were 32 sessions in the study.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Screened Participants | Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems | 0 Videoconferencing sessions |
| Virtual Health Enhancement Control | Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems | 0 Videoconferencing sessions |