Trial Outcomes & Findings for Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach (NCT NCT04942613)
NCT ID: NCT04942613
Last Updated: 2025-03-07
Results Overview
Adherence will be calculated as the proportion of the number of sessions attended out of the number prescribed per protocol (32 sessions)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Results posted on
2025-03-07
Participant Flow
Participant milestones
| Measure |
Multicomponent Telehealth Intervention (Group1)
This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program.
Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement.
Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise
Qualitative Interview: Qualitative interview to explore patient perspectives of the multicomponent telerehabilitation program (physical therapy, biobehavioral interventions, technology, and social support interventions) and how they contribute to program engagement and participation as well as changes in physical activity.
|
Education (Group2)
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
Qualitative Interview: Qualitative interview to explore patient perspectives of the multicomponent telerehabilitation program (physical therapy, biobehavioral interventions, technology, and social support interventions) and how they contribute to program engagement and participation as well as changes in physical activity.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
Completed 12 Week Oucomes
|
24
|
25
|
|
Overall Study
Not Completed 12 Week Outcomes
|
1
|
0
|
|
Overall Study
Started Multicomponent Telehealth Intervention (Group 2 Only)
|
0
|
25
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach
Baseline characteristics by cohort
| Measure |
Multicomponent Telehealth Intervention (Group1)
n=25 Participants
This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program.
Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement.
Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise
|
Education (Group2)
n=25 Participants
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
69.9 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
69.2 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Military Branch
Army
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Military Branch
Navy
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Military Branch
Air Force
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Military Branch
Marines
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Marital Status
Married
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Marital Status
Divorced or Separated
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Marital Status
Single
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Marital Status
Cohabitating
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
High School or Equivalent
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Education
Associates Degree or Some College
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Education
Bachelors Degree
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Education
Post-baccalaureate
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Employment
Retired
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Employment
Working (full- or part-time)
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Employment
Unemployed or other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Support at Home
All the time
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Support at Home
Some or Most of the Time
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Support at Home
No
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
BMI
|
30.9 kg/m^2
STANDARD_DEVIATION 6.6 • n=5 Participants
|
31.0 kg/m^2
STANDARD_DEVIATION 5.4 • n=7 Participants
|
31.0 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Functional Comorbidity Index
|
6.0 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 2.1 • n=7 Participants
|
6.0 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Functional Comorbidity Index Top 6 Diagnoses
Arthritis
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Functional Comorbidity Index Top 6 Diagnoses
Obesity (BMI > 30 kg/m2
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Functional Comorbidity Index Top 6 Diagnoses
Visual Impairment
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Functional Comorbidity Index Top 6 Diagnoses
Depression
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Functional Comorbidity Index Top 6 Diagnoses
Degenerative Disc Disease
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Functional Comorbidity Index Top 6 Diagnoses
Anxiety (Includes PTSD)
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Prescription Medications (total)
|
14.1 number of prescriptions
STANDARD_DEVIATION 7.9 • n=5 Participants
|
11.6 number of prescriptions
STANDARD_DEVIATION 5.3 • n=7 Participants
|
12.9 number of prescriptions
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Polypharmacy (≥ 5 meds)
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Top 3 Frequent Medications
Antidepressant
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Top 3 Frequent Medications
Diuretic
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Top 3 Frequent Medications
Beta Blocker
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Berkman Social Disengagement Scale (disengaged)
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Telephone Montreal Cognitive Assessment (cognitive impairment)
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Patient Health Questionnaire (PHQ-9) positive for depression
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Generalized Anxiety Disorder (GAD) positive for anxiety
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Mobile Device Proficiency Questionnaire (MDPQ-16)
|
67.9 units on a scale
STANDARD_DEVIATION 13.6 • n=5 Participants
|
69.2 units on a scale
STANDARD_DEVIATION 9.9 • n=7 Participants
|
68.5 units on a scale
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Number of Rural Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)Population: All participants; data from both groups will be pooled for analysis.
Adherence will be calculated as the proportion of the number of sessions attended out of the number prescribed per protocol (32 sessions)
Outcome measures
| Measure |
All Participants
n=32 Sessions
Combination of both arms
|
Education (Group2)
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
Adherence to the Multicomponent Telehealth Intervention
|
0.95 Proportion of sessions attended
Interval 0.81 to 1.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from pre-program (baseline for Group 1, 12 weeks for Group 2) to post-program (12 weeks for Group 1, 24 weeks for Group 2).Population: All participants with complete step count data will be analyzed. Since only pre-program and post-program data were collected, the data were pooled to increase statistical power.
Physical activity will be measured via accelerometry and will include average 7-day step count
Outcome measures
| Measure |
All Participants
n=36 Participants
Combination of both arms
|
Education (Group2)
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
Physical Activity
|
-95 steps
Interval -514.0 to 915.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)Population: All participants with complete data; data from both groups will be pooled for analysis.
Feasibility will be measured through a validated survey: Feasibility of Intervention Measure consists of 4 items rated on a 5-point Likert scale (1) completely disagree to (5) completely agree. The average of the 4 items are reported. Higher scores indicate greater feasibility of the program.
Outcome measures
| Measure |
All Participants
n=50 Participants
Combination of both arms
|
Education (Group2)
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
Feasibility of the Multicomponent Telehealth Intervention
|
5.0 units on a scale
Interval 4.8 to 5.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)Population: All participants with complete data; data from both groups will be pooled for analysis.
Acceptability will be measured through a validated survey: Acceptability of Intervention Measure consists of 4 items rated on a 5-point Likert scale (1) completely disagree to (5) completely agree. The average of the 4 items are reported. Higher scores indicate greater acceptability of the program."
Outcome measures
| Measure |
All Participants
n=50 Participants
Combination of both arms
|
Education (Group2)
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
Acceptability of the Multicomponent Telehealth Intervention
|
5.0 score on a scale
Interval 4.7 to 5.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Number phone screened
Recruitment will be tracked as part of feasibility and to inform a future trial. Recruitment will be reported as a proportion of those enrolled out of the total number screened via phone screen.
Outcome measures
| Measure |
All Participants
n=84 Participants
Combination of both arms
|
Education (Group2)
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
Participant Recruitment
|
50 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)Population: All participants with complete data; data from both groups will be pooled for analysis.
Participation satisfaction with care provided via telerehabilitation will be assessed via the VA's approved survey: V-signals. It consists of 11 items rated on a 5-point Likert scale from (1) strongly disagree to (5) strongly agree). The average of the 11 items are reported. Higher scores indicate better satisfaction.
Outcome measures
| Measure |
All Participants
n=50 Participants
Combination of both arms
|
Education (Group2)
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
Satisfaction of the Multicomponent Telehealth Intervention
|
4.9 score on a scale
Interval 4.6 to 5.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)Population: Number of adverse events
The Safety Event Count is the cumulative number of study related (possibly, probably, or definitely) adverse events and severe adverse events counted from baseline to program end. Events will be categorized by type
Outcome measures
| Measure |
All Participants
n=25 Participants
Combination of both arms
|
Education (Group2)
n=25 Participants
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
Safety Event Count
Falls
|
2 number of adverse events
|
1 number of adverse events
|
—
|
—
|
|
Safety Event Count
ED Visit
|
3 number of adverse events
|
1 number of adverse events
|
—
|
—
|
|
Safety Event Count
Hospitalization
|
1 number of adverse events
|
0 number of adverse events
|
—
|
—
|
|
Safety Event Count
Other
|
1 number of adverse events
|
3 number of adverse events
|
—
|
—
|
|
Safety Event Count
Unrelated Falls
|
13 number of adverse events
|
19 number of adverse events
|
—
|
—
|
|
Safety Event Count
Unrelated ED Visits
|
7 number of adverse events
|
10 number of adverse events
|
—
|
—
|
|
Safety Event Count
Unrelated Hospitalizations
|
4 number of adverse events
|
2 number of adverse events
|
—
|
—
|
|
Safety Event Count
Unrelated Other
|
4 number of adverse events
|
10 number of adverse events
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksPopulation: All Participants
Four-item questionnaire used to determine an individual's stage of change (pre-contemplation, contemplation, preparation, action, or maintenance)
Outcome measures
| Measure |
All Participants
n=25 Participants
Combination of both arms
|
Education (Group2)
n=24 Participants
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
n=25 Participants
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
n=25 Participants
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
Exercise Stages of Change Questionnaire
Pre-contemplation
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Exercise Stages of Change Questionnaire
Contemplation
|
8 Participants
|
3 Participants
|
12 Participants
|
11 Participants
|
|
Exercise Stages of Change Questionnaire
Preparation
|
12 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
|
Exercise Stages of Change Questionnaire
Action
|
1 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
|
Exercise Stages of Change Questionnaire
Maintenance
|
4 Participants
|
10 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksPopulation: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis.
Nine item questionnaire used to measure an individual's self-efficacy for exercising under different conditions. Each item is rated on a scale of 0 (not confident) to 10 (confident). The average of the 9 items is calculated; higher scores indicate better self-efficacy. The change from baseline to 12 weeks is calculated as 12 weeks minus baseline; thus, positive change scores indicate improvement in self-efficacy.
Outcome measures
| Measure |
All Participants
n=23 Participants
Combination of both arms
|
Education (Group2)
n=25 Participants
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
Self-efficacy for Exercise (SEE) Scale
|
0.0 score on a scale
Interval -2.8 to 1.0
|
0.0 score on a scale
Interval -1.8 to 1.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksPopulation: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis.
The test uses a standard height chair and requires the participant to stand up and sit down as many times as possible in 30 seconds. More completions indicate better physical function.
Outcome measures
| Measure |
All Participants
n=23 Participants
Combination of both arms
|
Education (Group2)
n=25 Participants
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
30 Second Sit to Stand
|
1.0 Number of sit to stand repetitions
Interval -1.0 to 4.0
|
1.0 Number of sit to stand repetitions
Interval 0.0 to 2.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksPopulation: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis. Group 2 had 1 participant not complete this outcome measure.
This is a functional performance test for upper body strength and is performed on each arm (one arm at a time). It requires the participant to perform as many arm curls (biceps curls) as possible in 30 seconds. Males use an 8lb weight and females use a 5lb weight. Scores are continuous, and higher scores indicate greater arm strength (better outcome)
Outcome measures
| Measure |
All Participants
n=23 Participants
Combination of both arms
|
Education (Group2)
n=24 Participants
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
Arm Curl Test
Dominant
|
3.0 Number of arm curl repetitions
Interval 0.0 to 5.0
|
0.5 Number of arm curl repetitions
Interval -1.5 to 4.0
|
—
|
—
|
|
Arm Curl Test
Non-dominant
|
3.0 Number of arm curl repetitions
Interval 0.0 to 5.5
|
1 Number of arm curl repetitions
Interval -0.5 to 3.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksPopulation: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis.
This is a functional performance test for aerobic endurance. It requires participants to march in place for 2 minutes (alternating legs), and the score is the number of repetitions completed on the right leg. Scores are continuous, and higher scores indicate better aerobic endurance.
Outcome measures
| Measure |
All Participants
n=23 Participants
Combination of both arms
|
Education (Group2)
n=25 Participants
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
2-minute Step Test
|
15.0 number of repetitions
Interval 7.0 to 31.0
|
0.0 number of repetitions
Interval -5.0 to 15.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksPopulation: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis.
This questionnaire consists of 18 items rated on a 4-point Likert scale from 1 (unable) to 4 (none) to address the prompt: How much difficulty do you currently have. The total score is reported by summing each item; scores can range from 18 to 72. Higher scores indicate better mobility and less impairment/disability.
Outcome measures
| Measure |
All Participants
n=23 Participants
Combination of both arms
|
Education (Group2)
n=25 Participants
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Routine Short Form
|
4.0 units on a scale
Interval -2.0 to 11.0
|
1.6 units on a scale
Interval 0.0 to 7.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksPopulation: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis.
This scale has three items and a simplified set of response categories that is designed to measure overall loneliness. Score range: 3-9. Higher scores indicate higher loneliness.
Outcome measures
| Measure |
All Participants
n=23 Participants
Combination of both arms
|
Education (Group2)
n=25 Participants
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
3-Item Loneliness Scale
|
0.0 units on a scale
Interval 0.0 to 1.1
|
0.0 units on a scale
Interval -1.0 to 0.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline to 12 weeksPopulation: All participants completing the 12 week testing. Group 1 had 1 withdrawal and 1 participant unable to complete all outcome measures due to new medical diagnosis.
This is a patient reported outcome measure to assess physical health (subscale) and mental health (subscale). It is a 29-item questionnaire, and most items are rated on a 5-point Likert scale. There is 1 pain intensity item rated on a 0 (no pain) to 10 (worst pain imaginable) scale. PROMIS scores were transformed to a T-score where 50 represents the population mean, and the standard deviation is 10. The method reported by Hays et al. in 2018 was used to calculate the physical health and mental health subscales. Higher scores for subscales listed indicate better physical and mental health.
Outcome measures
| Measure |
All Participants
n=23 Participants
Combination of both arms
|
Education (Group2)
n=25 Participants
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
PROMIS-29+2 Profile v2.1 Physical Health and Mental Health Subscales Only
Physical Health
|
2.1 score on a scale
Interval -0.4 to 4.3
|
-0.3 score on a scale
Interval -2.2 to 3.1
|
—
|
—
|
|
PROMIS-29+2 Profile v2.1 Physical Health and Mental Health Subscales Only
Mental Health
|
0.3 score on a scale
Interval -1.8 to 7.0
|
-2.1 score on a scale
Interval -6.2 to 1.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 Weeks and 24 WeeksPopulation: Total number of participants. The investigators considered retention to be study retention in addition to intervention retention, which included the outcome assessments at all time points. Thus, even though participants in Group 1 did not receive any intervention from weeks 12-24, they were still considered enrolled in the study until their 24 week outcome assessment was completed, they withdrew, or were lost to follow-up.
Participant retention will be tracked as part of feasibility and to inform a future trial. Retention will be reported as a proportion of the total number of participants who complete all outcome measure timepoints out of the total who complete baseline measures.
Outcome measures
| Measure |
All Participants
n=25 Participants
Combination of both arms
|
Education (Group2)
n=25 Participants
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group2) Baseline
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Education (Group 2) 12 Weeks
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
Participant Retention
12 Week Retention
|
24 Participants
|
25 Participants
|
—
|
—
|
|
Participant Retention
24 Week Retention
|
20 Participants
|
22 Participants
|
—
|
—
|
Adverse Events
Multicomponent Telehealth Intervention (Group1) During and Related to Intervention
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Education (Group 2) During and Related to Multicomponent Telehealth Intervention
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Multicomponent Telehealth Intervention (Group 1) Not During and Not Related to Intervention
Serious events: 0 serious events
Other events: 12 other events
Deaths: 1 deaths
Education (Group 2) Not During and Not Related to Intervention
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Multicomponent Telehealth Intervention (Group1) During and Related to Intervention
n=25 participants at risk
This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program.
Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement.
Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise
|
Education (Group 2) During and Related to Multicomponent Telehealth Intervention
n=25 participants at risk
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
Multicomponent Telehealth Intervention (Group 1) Not During and Not Related to Intervention
n=25 participants at risk
This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program.
Motivational Interviewing Techniques: Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement.
Physical Therapy Interventions: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise
|
Education (Group 2) Not During and Not Related to Intervention
n=25 participants at risk
This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention
Education: Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac
|
12.0%
3/25 • Number of events 3 • 24 weeks
|
12.0%
3/25 • Number of events 3 • 24 weeks
|
8.0%
2/25 • Number of events 3 • 24 weeks
|
24.0%
6/25 • Number of events 10 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
8.0%
2/25 • Number of events 2 • 24 weeks
|
0.00%
0/25 • 24 weeks
|
4.0%
1/25 • Number of events 1 • 24 weeks
|
16.0%
4/25 • Number of events 4 • 24 weeks
|
|
General disorders
Fall
|
8.0%
2/25 • Number of events 2 • 24 weeks
|
4.0%
1/25 • Number of events 1 • 24 weeks
|
40.0%
10/25 • Number of events 12 • 24 weeks
|
40.0%
10/25 • Number of events 19 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infection
|
0.00%
0/25 • 24 weeks
|
0.00%
0/25 • 24 weeks
|
12.0%
3/25 • Number of events 4 • 24 weeks
|
12.0%
3/25 • Number of events 3 • 24 weeks
|
Additional Information
Dr. Jennifer Stevens-Lapsley
University of Colorado Denver, Anschutz Medical Campus
Phone: 303.724.9170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place