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Stay Connected: Testing an Intervention to Combat Coronavirus-related Social Isolation Among Older Adults

Stay Connected: Testing an Intervention to Combat COVID-19 Related Social Isolation Among Seattle-area Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04966910
Enrollment
44
Registered
2021-07-19
Start date
2021-04-09
Completion date
2022-06-13
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Loneliness

Brief summary

This study will use the University of Washington's ALACRITY Center's (UWAC) Discover, Design, Build, & Test (DDBT) method to develop and test an intervention to address the mental health health needs of older adults in senior housing (clients) who are forced to not only shelter-in-place but cannot have family or other visitors during this time. Older people (those over 60 years in age) are especially vulnerable and are more likely to have severe - even deadly - coronavirus infection than other age groups. These facts led to the need to have older adults socially isolate in order to protect their health; visits with family and friends are limited, and in senior housing (independent, supported and assisted care residences) have limited such visits by family to one person a day. This necessary practice of social distancing, while addressing an important public health crisis, unintentionally creates social isolation and loneliness, another deadly epidemic amongst the older population. Even before COVID-19, social isolation and loneliness was a prominent mental health and social problem in the aged, one that is associated with increases in other chronic conditions, dementia and suicide. Effective interventions for social isolation exist but are difficult to access and may not address all the concerns older adults have about this particular period of social isolation. The purpose of this proposed study is to deploy an adaptation of Behavioral Activation Therapy called Stay Connected to treat depression in older adults. The adaptation will allow activity directors and staff (clinicians) in these settings and senior centers to deliver the therapeutic elements of the intervention (behavioral activation) in the context of social distancing/shelter-in-place policies. Social workers in these settings will oversee the activity director and staff delivery of the intervention. The investigators are working with a variety of senior housing types (HUD certified and private systems) and senior centers in Skagit county (rural) and King county (urban) in Washington (WA) so that the resulting intervention is not tied to economic levels or access to digital technology.

Detailed description

Clinicians and clients from 6 rural and urban senior communities or senior centers will participate in this study. Senior communities or senior centers will be randomized to receive training and materials in either Stay Connected or a resource guide. The investigators will work with 2 staff from each community or senior center and conduct baseline, 4 week and 9 week assessments with clinicians and 20 clients from each community setting (N=12 clinicians and 120 clients).

Interventions

BEHAVIORALStay Connected

Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.

BEHAVIORALTreatment as usual

Regular check-ins, resource/referral provision

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Older Adult Participants Inclusion Criteria: 1. 60 years of age or older 2. Physical and cognitive ability to complete interviews by phone or using video-chat technology (e.g., Zoom) 3. English speaking 4. Resident of participating Seattle-area senior living communities or member of Seattle-area senior centers 5. Ability to provide consent 6. Score of 5 or higher on Patient Health Questionnaire (PHQ-9) or score of 5 or higher on Generalized Anxiety Disorder Scale (GAD-7) or score of 6 or higher on University of California Los Angeles (UCLA) Loneliness Scale 7. No suicidal ideation

Exclusion criteria

1. Under the age of 60 2. Inability to physically and/or cognitively consent and/or participate in study procedures via phone, computer, and/or video call 3. Non-English speaking 4. Scores below inclusion cut-offs on PHQ-9, GAD-7, and UCLA Loneliness Scale Staff Participants Inclusion Criteria 1. English-speaking 2. Staff members in administration, social work, and/or activities department in Seattle area senior living communities or senior centers 3. Physical ability to complete training in intervention and complete questionnaires by phone, computer, or video-chat technology

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire (PHQ-9)Baseline, 4-Week Follow-Up, and 9-Week Follow-UpThe 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.
Generalized Anxiety Disorder (GAD-7)Baseline, 4-Week Follow-Up, and 9-Week Follow-UpTo 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.
Sheehan Disability Scale (SDS)Baseline, 4-Week Follow-Up and 9-Week Follow-UpThe 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.

Secondary

MeasureTime frameDescription
Acceptability of Intervention Measure (AIM)Baseline and 9 week follow upThis 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).
University of California Los Angeles (UCLA) Loneliness ScaleBaseline, 4-Week Follow-Up, and 9-Week Follow-UpA 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.
Intervention Appropriateness Measure (IAM)Baseline, 9 week follow upThis 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).
Intervention Usability Scale (IUS)9 weeksThis 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.
Behavioral Activation Scale (BADS)Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.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.
Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation - Short VersionBaseline, 4-Week Follow-Up, and 9-Week Follow-UpThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
17
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
14
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 the clinicians who delivered the Stay Connected intervention.
1
Usual Care Clinicians
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.
2
Total34

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
4-Week Follow-UpClients did not complete measure at this timepoint5400
9-Week Follow-UpParticipant did not complete measure3100
9-Week Follow-UpWithdrawal by Subject0002
BaselineParticipant did not complete measure0010

Baseline characteristics

CharacteristicTotalStay Connected ClientsUsual Care ClientsStay Connected CliniciansUsual Care Clinicians
Age, Continuous73.5 years
STANDARD_DEVIATION 6.2
74.4 years
STANDARD_DEVIATION 7
72.3 years
STANDARD_DEVIATION 4.9
28.0 years38.0 years
STANDARD_DEVIATION 7.07
Education Level
Associate degree
3 Participants0 Participants2 Participants0 Participants1 Participants
Education Level
Bachelors degree
6 Participants3 Participants2 Participants1 Participants0 Participants
Education Level
High school graduate or equivalent
2 Participants1 Participants1 Participants0 Participants0 Participants
Education Level
Masters degree
7 Participants5 Participants1 Participants0 Participants1 Participants
Education Level
Professional or doctorate
3 Participants1 Participants2 Participants0 Participants0 Participants
Education Level
Some college, no degree
13 Participants7 Participants6 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants3 Participants1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
27 Participants14 Participants11 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants0 Participants2 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
White
31 Participants17 Participants12 Participants1 Participants1 Participants
Sex: Female, Male
Female
27 Participants16 Participants11 Participants
Sex: Female, Male
Male
4 Participants1 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 180 / 20 / 2
other
Total, other adverse events
0 / 220 / 180 / 20 / 2
serious
Total, serious adverse events
0 / 220 / 180 / 20 / 2

Outcome results

Primary

Generalized Anxiety Disorder (GAD-7)

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.

Time frame: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up

Population: Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Stay Connected ClientsGeneralized Anxiety Disorder (GAD-7)Baseline5.82 score on a scaleStandard Deviation 5.64
Stay Connected ClientsGeneralized Anxiety Disorder (GAD-7)4-Week Follow-Up4.35 score on a scaleStandard Deviation 4.11
Stay Connected ClientsGeneralized Anxiety Disorder (GAD-7)9-Week Follow-Up4.59 score on a scaleStandard Deviation 5.1
Usual Care ClientsGeneralized Anxiety Disorder (GAD-7)Baseline4.43 score on a scaleStandard Deviation 3.06
Usual Care ClientsGeneralized Anxiety Disorder (GAD-7)4-Week Follow-Up3.71 score on a scaleStandard Deviation 2.7
Usual Care ClientsGeneralized Anxiety Disorder (GAD-7)9-Week Follow-Up4.93 score on a scaleStandard Deviation 3.12
p-value: 0.226ANOVA
Primary

Patient Health Questionnaire (PHQ-9)

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.

Time frame: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up

Population: Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Stay Connected ClientsPatient Health Questionnaire (PHQ-9)Baseline9.24 score on a scaleStandard Deviation 6.08
Stay Connected ClientsPatient Health Questionnaire (PHQ-9)4-Week Follow-Up7.29 score on a scaleStandard Deviation 4.55
Stay Connected ClientsPatient Health Questionnaire (PHQ-9)9-Week Follow-Up6.47 score on a scaleStandard Deviation 5.08
Usual Care ClientsPatient Health Questionnaire (PHQ-9)Baseline7.29 score on a scaleStandard Deviation 4.48
Usual Care ClientsPatient Health Questionnaire (PHQ-9)4-Week Follow-Up6.29 score on a scaleStandard Deviation 5.03
Usual Care ClientsPatient Health Questionnaire (PHQ-9)9-Week Follow-Up7.50 score on a scaleStandard Deviation 5.16
Comparison: Repeated measures ANOVA including a time x condition interaction term to test for differences in slopes by condition for client data.p-value: 0.036ANOVA
Primary

Sheehan Disability Scale (SDS)

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.

Time frame: Baseline, 4-Week Follow-Up and 9-Week Follow-Up

Population: Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Stay Connected ClientsSheehan Disability Scale (SDS)Baseline9.18 score on a scaleStandard Deviation 9.36
Stay Connected ClientsSheehan Disability Scale (SDS)4-Week Follow-Up6.94 score on a scaleStandard Deviation 8.72
Stay Connected ClientsSheehan Disability Scale (SDS)9-Week Follow-Up8.53 score on a scaleStandard Deviation 9.45
Usual Care ClientsSheehan Disability Scale (SDS)Baseline8.29 score on a scaleStandard Deviation 7.78
Usual Care ClientsSheehan Disability Scale (SDS)4-Week Follow-Up7.21 score on a scaleStandard Deviation 7.38
Usual Care ClientsSheehan Disability Scale (SDS)9-Week Follow-Up9.71 score on a scaleStandard Deviation 9.54
p-value: 0.674ANOVA
Secondary

Acceptability of Intervention Measure (AIM)

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).

Time frame: Baseline and 9 week follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Stay Connected ClientsAcceptability of Intervention Measure (AIM)Baseline4.0 score on a scale
Stay Connected ClientsAcceptability of Intervention Measure (AIM)9 week follow up4.38 score on a scaleStandard Deviation 0.88
Usual Care ClientsAcceptability of Intervention Measure (AIM)Baseline4.63 score on a scaleStandard Deviation 0.53
Secondary

Behavioral Activation Scale (BADS)

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.

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
Stay Connected ClientsBehavioral Activation Scale (BADS)Baseline91.06 score on a scaleStandard Deviation 26.25
Stay Connected ClientsBehavioral Activation Scale (BADS)4-Week Follow-Up95.53 score on a scaleStandard Deviation 25.01
Stay Connected ClientsBehavioral Activation Scale (BADS)9-Week Follow-Up97.88 score on a scaleStandard Deviation 18.58
Usual Care ClientsBehavioral Activation Scale (BADS)Baseline94.64 score on a scaleStandard Deviation 20.14
Usual Care ClientsBehavioral Activation Scale (BADS)4-Week Follow-Up99.01 score on a scaleStandard Deviation 23.32
Usual Care ClientsBehavioral Activation Scale (BADS)9-Week Follow-Up97.71 score on a scaleStandard Deviation 26.87
p-value: 0.741ANOVA
Secondary

Intervention Appropriateness Measure (IAM)

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).

Time frame: Baseline, 9 week follow up

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Stay Connected ClientsIntervention Appropriateness Measure (IAM)Baseline5.00 score on a scale
Stay Connected ClientsIntervention Appropriateness Measure (IAM)9 weeks5.00 score on a scaleStandard Deviation 0
Usual Care ClientsIntervention Appropriateness Measure (IAM)Baseline4.63 score on a scaleStandard Deviation 0.53
Secondary

Intervention Usability Scale (IUS)

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.

Time frame: 9 weeks

Population: Data collected from Stay Connected group at 9 weeks only.

ArmMeasureValue (MEAN)Dispersion
Stay Connected ClientsIntervention Usability Scale (IUS)85 score on a scaleStandard Deviation 7.07
Secondary

Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation - Short Version

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.

Time frame: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up

Population: Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Stay Connected ClientsPatient Reported Outcome Measurement Information System (PROMIS) Social Isolation - Short VersionBaseline11.76 score on a scaleStandard Deviation 3.82
Stay Connected ClientsPatient Reported Outcome Measurement Information System (PROMIS) Social Isolation - Short Version4-Week Follow-Up10.24 score on a scaleStandard Deviation 3.31
Stay Connected ClientsPatient Reported Outcome Measurement Information System (PROMIS) Social Isolation - Short Version9-Week Follow-Up10.12 score on a scaleStandard Deviation 3.6
Usual Care ClientsPatient Reported Outcome Measurement Information System (PROMIS) Social Isolation - Short VersionBaseline10.50 score on a scaleStandard Deviation 3.01
Usual Care ClientsPatient Reported Outcome Measurement Information System (PROMIS) Social Isolation - Short Version4-Week Follow-Up9.71 score on a scaleStandard Deviation 4.14
Usual Care ClientsPatient Reported Outcome Measurement Information System (PROMIS) Social Isolation - Short Version9-Week Follow-Up9.43 score on a scaleStandard Deviation 3.44
p-value: 0.737ANOVA
Secondary

University of California Los Angeles (UCLA) Loneliness Scale

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.

Time frame: Baseline, 4-Week Follow-Up, and 9-Week Follow-Up

Population: Client participants contributing Baseline, 4-Week Follow-Up, and 9-Week Follow-Up data, excluding cases missing at any timepoint.

ArmMeasureGroupValue (MEAN)Dispersion
Stay Connected ClientsUniversity of California Los Angeles (UCLA) Loneliness ScaleBaseline6.53 score on a scaleStandard Deviation 1.74
Stay Connected ClientsUniversity of California Los Angeles (UCLA) Loneliness Scale4-Week Follow-Up5.53 score on a scaleStandard Deviation 1.87
Stay Connected ClientsUniversity of California Los Angeles (UCLA) Loneliness Scale9-Week Follow-Up5.88 score on a scaleStandard Deviation 2.09
Usual Care ClientsUniversity of California Los Angeles (UCLA) Loneliness ScaleBaseline5.29 score on a scaleStandard Deviation 1.27
Usual Care ClientsUniversity of California Los Angeles (UCLA) Loneliness Scale4-Week Follow-Up5.00 score on a scaleStandard Deviation 2
Usual Care ClientsUniversity of California Los Angeles (UCLA) Loneliness Scale9-Week Follow-Up5.00 score on a scaleStandard Deviation 1.66
p-value: 0.317ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026