Trial Outcomes & Findings for Stay Connected: Testing an Intervention to Combat Coronavirus-related Social Isolation Among Older Adults (NCT NCT04966910)
NCT ID: NCT04966910
Last Updated: 2024-04-23
Results Overview
The PHQ-9 consists of 9 depression items and one disability item. Each item is associated with a symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time. Older adult participants will complete this measure. Total score ranges from 0 - 27 and higher scores indicate higher levels of depression symptoms.
COMPLETED
NA
44 participants
Baseline, 4-Week Follow-Up, and 9-Week Follow-Up
2024-04-23
Participant Flow
Unit of analysis: Clinics, with one staff in each clinic
Participant milestones
| Measure |
Stay Connected Clients
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles. This group is for the clients who received the intervention.
|
Usual Care Clients
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision. This group is for the clients who received treatment as usual.
|
Stay Connected Clinicians
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles. This group is for the clinicians who delivered the intervention.
|
Usual Care Staff
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision. This group is for the clinicians who delivered treatment as usual.
|
|---|---|---|---|---|
|
Baseline
STARTED
|
22 2
|
18 2
|
2 2
|
2 2
|
|
Baseline
COMPLETED
|
22 2
|
18 2
|
1 1
|
2 2
|
|
Baseline
NOT COMPLETED
|
0 0
|
0 0
|
1 1
|
0 0
|
|
4-Week Follow-Up
STARTED
|
22 2
|
18 2
|
0 0
|
0 0
|
|
4-Week Follow-Up
COMPLETED
|
17 2
|
14 2
|
0 0
|
0 0
|
|
4-Week Follow-Up
NOT COMPLETED
|
5 0
|
4 0
|
0 0
|
0 0
|
|
9-Week Follow-Up
STARTED
|
22 2
|
18 2
|
2 2
|
2 2
|
|
9-Week Follow-Up
COMPLETED
|
19 2
|
17 2
|
2 2
|
0 0
|
|
9-Week Follow-Up
NOT COMPLETED
|
3 0
|
1 0
|
0 0
|
2 2
|
Reasons for withdrawal
| Measure |
Stay Connected Clients
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles. This group is for the clients who received the intervention.
|
Usual Care Clients
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision. This group is for the clients who received treatment as usual.
|
Stay Connected Clinicians
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles. This group is for the clinicians who delivered the intervention.
|
Usual Care Staff
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision. This group is for the clinicians who delivered treatment as usual.
|
|---|---|---|---|---|
|
Baseline
Participant did not complete measure
|
0
|
0
|
1
|
0
|
|
4-Week Follow-Up
Clients did not complete measure at this timepoint
|
5
|
4
|
0
|
0
|
|
9-Week Follow-Up
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
|
9-Week Follow-Up
Participant did not complete measure
|
3
|
1
|
0
|
0
|
Baseline Characteristics
Clinicians were not asked about their sex
Baseline characteristics by cohort
| Measure |
Stay Connected Clients
n=17 Participants
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.
|
Usual Care Clients
n=14 Participants
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision
|
Stay Connected Clinicians
n=1 Participants
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles. This group is the clinicians who delivered the Stay Connected intervention.
|
Usual Care Clinicians
n=2 Participants
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision. this group is the clinicians who delivered usual care.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
16 Participants
n=17 Participants • Clinicians were not asked about their sex
|
11 Participants
n=14 Participants • Clinicians were not asked about their sex
|
—
|
—
|
27 Participants
n=31 Participants • Clinicians were not asked about their sex
|
|
Sex: Female, Male
Male
|
1 Participants
n=17 Participants • Clinicians were not asked about their sex
|
3 Participants
n=14 Participants • Clinicians were not asked about their sex
|
—
|
—
|
4 Participants
n=31 Participants • Clinicians were not asked about their sex
|
|
Age, Continuous
|
74.4 years
STANDARD_DEVIATION 7.0 • n=17 Participants • 1 participant in the Usual Care arm did not contribute age data within the analytic sample.
|
72.3 years
STANDARD_DEVIATION 4.9 • n=13 Participants • 1 participant in the Usual Care arm did not contribute age data within the analytic sample.
|
28.0 years
n=1 Participants • 1 participant in the Usual Care arm did not contribute age data within the analytic sample.
|
38.0 years
STANDARD_DEVIATION 7.07 • n=2 Participants • 1 participant in the Usual Care arm did not contribute age data within the analytic sample.
|
73.5 years
STANDARD_DEVIATION 6.2 • n=33 Participants • 1 participant in the Usual Care arm did not contribute age data within the analytic sample.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=17 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
5 Participants
n=34 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=17 Participants
|
11 Participants
n=14 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
27 Participants
n=34 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=17 Participants
|
2 Participants
n=14 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=34 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=17 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=17 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=17 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=17 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=34 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=17 Participants
|
12 Participants
n=14 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
31 Participants
n=34 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=17 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=17 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=34 Participants
|
|
Education Level
High school graduate or equivalent
|
1 Participants
n=17 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=34 Participants
|
|
Education Level
Some college, no degree
|
7 Participants
n=17 Participants
|
6 Participants
n=14 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
13 Participants
n=34 Participants
|
|
Education Level
Associate degree
|
0 Participants
n=17 Participants
|
2 Participants
n=14 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=34 Participants
|
|
Education Level
Bachelors degree
|
3 Participants
n=17 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
6 Participants
n=34 Participants
|
|
Education Level
Masters degree
|
5 Participants
n=17 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
7 Participants
n=34 Participants
|
|
Education Level
Professional or doctorate
|
1 Participants
n=17 Participants
|
2 Participants
n=14 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=34 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4-Week Follow-Up, and 9-Week Follow-UpPopulation: Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.
The PHQ-9 consists of 9 depression items and one disability item. Each item is associated with a symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time. Older adult participants will complete this measure. Total score ranges from 0 - 27 and higher scores indicate higher levels of depression symptoms.
Outcome measures
| Measure |
Stay Connected Clients
n=17 Participants
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.
|
Usual Care Clients
n=14 Participants
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
Baseline
|
9.24 score on a scale
Standard Deviation 6.08
|
7.29 score on a scale
Standard Deviation 4.48
|
|
Patient Health Questionnaire (PHQ-9)
4-Week Follow-Up
|
7.29 score on a scale
Standard Deviation 4.55
|
6.29 score on a scale
Standard Deviation 5.03
|
|
Patient Health Questionnaire (PHQ-9)
9-Week Follow-Up
|
6.47 score on a scale
Standard Deviation 5.08
|
7.50 score on a scale
Standard Deviation 5.16
|
PRIMARY outcome
Timeframe: Baseline, 4-Week Follow-Up, and 9-Week Follow-UpPopulation: Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.
To assess for co-occurring anxiety, we will use the GAD-7, a 7- item screener for generalized anxiety. It consists of items related to GAD. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks. The scale is a valid screener for GAD. Older adult participants will complete this measure. Total score ranges from 0 - 21, with higher scores mean an increased degree of severity of anxiety symptoms.
Outcome measures
| Measure |
Stay Connected Clients
n=17 Participants
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.
|
Usual Care Clients
n=14 Participants
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision
|
|---|---|---|
|
Generalized Anxiety Disorder (GAD-7)
Baseline
|
5.82 score on a scale
Standard Deviation 5.64
|
4.43 score on a scale
Standard Deviation 3.06
|
|
Generalized Anxiety Disorder (GAD-7)
4-Week Follow-Up
|
4.35 score on a scale
Standard Deviation 4.11
|
3.71 score on a scale
Standard Deviation 2.70
|
|
Generalized Anxiety Disorder (GAD-7)
9-Week Follow-Up
|
4.59 score on a scale
Standard Deviation 5.10
|
4.93 score on a scale
Standard Deviation 3.12
|
PRIMARY outcome
Timeframe: Baseline, 4-Week Follow-Up and 9-Week Follow-UpPopulation: Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.
The SDS will be used as measure of disability/functional status. This is a brief analog disability scale, which uses visual-spatial, numeric and verbal anchors. The scale has been validated in medical and psychiatric populations with a variety of psychiatric diagnoses. Older adult participants will complete this measure. Total score ranges from 0 - 30, with higher scores indicating greater disruptions to their life from mental health symptoms.
Outcome measures
| Measure |
Stay Connected Clients
n=17 Participants
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.
|
Usual Care Clients
n=14 Participants
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision
|
|---|---|---|
|
Sheehan Disability Scale (SDS)
4-Week Follow-Up
|
6.94 score on a scale
Standard Deviation 8.72
|
7.21 score on a scale
Standard Deviation 7.38
|
|
Sheehan Disability Scale (SDS)
Baseline
|
9.18 score on a scale
Standard Deviation 9.36
|
8.29 score on a scale
Standard Deviation 7.78
|
|
Sheehan Disability Scale (SDS)
9-Week Follow-Up
|
8.53 score on a scale
Standard Deviation 9.45
|
9.71 score on a scale
Standard Deviation 9.54
|
SECONDARY outcome
Timeframe: Baseline, 4-Week Follow-Up, and 9-Week Follow-UpPopulation: Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.
A 3-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as either O ("I often feel this way"), S ("I sometimes feel this way"), R ("I rarely feel this way"), N ("I never feel this way"). Older adult participants will complete this measure. Total scores range from 3 - 9, with higher scores indicating higher levels of loneliness.
Outcome measures
| Measure |
Stay Connected Clients
n=17 Participants
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.
|
Usual Care Clients
n=14 Participants
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision
|
|---|---|---|
|
University of California Los Angeles (UCLA) Loneliness Scale
Baseline
|
6.53 score on a scale
Standard Deviation 1.74
|
5.29 score on a scale
Standard Deviation 1.27
|
|
University of California Los Angeles (UCLA) Loneliness Scale
4-Week Follow-Up
|
5.53 score on a scale
Standard Deviation 1.87
|
5.00 score on a scale
Standard Deviation 2.00
|
|
University of California Los Angeles (UCLA) Loneliness Scale
9-Week Follow-Up
|
5.88 score on a scale
Standard Deviation 2.09
|
5.00 score on a scale
Standard Deviation 1.66
|
SECONDARY outcome
Timeframe: Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.Population: Participants contributing data at Baseline, 4-Week Follow-Up and 9-Week Follow-Up
The Behavioral Activation for Depression Scale (BADS) can be used to track changes weekly in the behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. It examines changes in the following areas: activation, avoidance/rumination, work/school impairment, and social impairment. The BADS consists of 25 questions, each rated on a seven-point scale ranging from 0 (not at all) to 6 (completely). Older adult participants will complete this measure. Total scores range from 0 - 150, with higher scores indicating more behavioral activation.
Outcome measures
| Measure |
Stay Connected Clients
n=17 Participants
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.
|
Usual Care Clients
n=14 Participants
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision
|
|---|---|---|
|
Behavioral Activation Scale (BADS)
Baseline
|
91.06 score on a scale
Standard Deviation 26.25
|
94.64 score on a scale
Standard Deviation 20.14
|
|
Behavioral Activation Scale (BADS)
4-Week Follow-Up
|
95.53 score on a scale
Standard Deviation 25.01
|
99.01 score on a scale
Standard Deviation 23.32
|
|
Behavioral Activation Scale (BADS)
9-Week Follow-Up
|
97.88 score on a scale
Standard Deviation 18.58
|
97.71 score on a scale
Standard Deviation 26.87
|
SECONDARY outcome
Timeframe: Baseline, 4-Week Follow-Up, and 9-Week Follow-UpPopulation: Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.
The PROMIS Social Isolation item bank assesses perceptions of being avoided, excluded, detached, disconnected from, or unknown by, others. This measure consists of 4 items, each rated on a five-point scale ranging from 1 - 5. Older adult participants will complete this measure. Total scores range from 4 - 20, with higher scores meaning more social isolation.
Outcome measures
| Measure |
Stay Connected Clients
n=17 Participants
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.
|
Usual Care Clients
n=14 Participants
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision
|
|---|---|---|
|
Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation - Short Version
Baseline
|
11.76 score on a scale
Standard Deviation 3.82
|
10.50 score on a scale
Standard Deviation 3.01
|
|
Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation - Short Version
4-Week Follow-Up
|
10.24 score on a scale
Standard Deviation 3.31
|
9.71 score on a scale
Standard Deviation 4.14
|
|
Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation - Short Version
9-Week Follow-Up
|
10.12 score on a scale
Standard Deviation 3.60
|
9.43 score on a scale
Standard Deviation 3.44
|
SECONDARY outcome
Timeframe: Baseline and 9 week follow upPopulation: Both Clinicians who delivered Usual Care dropped out of the study after baseline assessment. Only one clinician in the Stay Connected group completed baseline assessment.
This is a four item measure of intervention acceptability, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable, and the total score is a mean item score with minimum score of 1 and maximum of 5. Clinician participants complete this measure. Higher values are considered to be more positive (i.e., a more acceptable intervention).
Outcome measures
| Measure |
Stay Connected Clients
n=2 Participants
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.
|
Usual Care Clients
n=2 Participants
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision
|
|---|---|---|
|
Acceptability of Intervention Measure (AIM)
Baseline
|
4.0 score on a scale
|
4.63 score on a scale
Standard Deviation 0.53
|
|
Acceptability of Intervention Measure (AIM)
9 week follow up
|
4.38 score on a scale
Standard Deviation 0.88
|
—
|
SECONDARY outcome
Timeframe: 9 weeksPopulation: Data collected from Stay Connected group at 9 weeks only.
This is a ten item measure of how easy the intervention/system is to use and learn. Used for interventions (e.g., therapeutic modalities). Total scale scores range from 0 to 100, with higher scores considered to be more positive (i.e., a more usable intervention). Scores of 70 and higher are considered to be a usable intervention. Clinician participants complete this measure.
Outcome measures
| Measure |
Stay Connected Clients
n=2 Participants
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.
|
Usual Care Clients
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision
|
|---|---|---|
|
Intervention Usability Scale (IUS)
|
85 score on a scale
Standard Deviation 7.07
|
—
|
SECONDARY outcome
Timeframe: Baseline, 9 week follow upPopulation: Only clinicians were administered the measure. Both usual care clinicians dropped out of the study after baseline. Only 1 clinician in the Stay Connected group responded at baseline.
This is a four item measure of how suitable an intervention is for the circumstances, where each item is rated on a 1-5 scale, with 1 = not at all appropriate and 5 = very appropriate, and the total score is a mean item score with minimum score of 1 and maximum of 5. Clinician participants complete this measure. Higher values are considered to be more positive (i.e., a more appropriate intervention).
Outcome measures
| Measure |
Stay Connected Clients
n=2 Participants
Menu-driven set of strategies to combat loneliness, anxiety and depression in older adults
Stay Connected: Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.
|
Usual Care Clients
n=2 Participants
Treatment as usual in these practice settings typically includes regular check-in calls and offering resources and referrals
Treatment as usual: Regular check-ins, resource/referral provision
|
|---|---|---|
|
Intervention Appropriateness Measure (IAM)
Baseline
|
5.00 score on a scale
|
4.63 score on a scale
Standard Deviation 0.53
|
|
Intervention Appropriateness Measure (IAM)
9 weeks
|
5.00 score on a scale
Standard Deviation 0
|
—
|
Adverse Events
Stay Connected Clients
Usual Care Clients
Stay Connected Clinicians
Usual Care Clinicians
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place