N/A
N=9,374
Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings
Intellectual Disability · Developmental Disability · Axis I Diagnosis · Mental Illness · Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04726371 ↗Enrolled (actual)
9,374
Serious AEs
0.7%
Results posted
Feb 2025
Primary outcome: Primary: New COVID-19 Group Home Incidence — 1.61; 1.40; 0.16; 0.09 New COVID-19 cases per 100 person-months — p=0.89
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Generic Best Practices (Behavioral); Tailored Best Practices (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY New COVID-19 Group Home Incidence |
1.61; 1.40; 0.16; 0.09; 0.69; 0.55 | 0.89 |
| PRIMARY Best Practices Fidelity |
82.01; 80.27; 85.96; 86.11; 84.98; 86.14 | >.99 |
| PRIMARY Full COVID-19 Vaccination Status Among Residents |
73; 77 | >.99 |
| PRIMARY Full COVID-19 Vaccination Status Among Staff |
467; 471 | >.99 |
Summary
Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings is a research study aimed at developing, implementing, and evaluating a package of interventions specifically designed to reduce COVID-19 and other infectious-disease incidence, hospitalizations, and mortality among staff and adults with Serious Mental Illness and Intellectual and Developmental Disabilities in congregate-living settings.
Eligibility Criteria
Inclusion Criteria
- All congregate care homes in Massachusetts operated by the following public-sector community-based human service organizations: Vinfen, Bay Cove, Advocates, North Suffolk, Open Sky, and Riverside
- The group home must serve adults with SMI (Serious Mental Illness, i.e., DSM-V Diagnosis of Axis-I Mental Illness with persistent functional impairment) or adults with ID/DD (Intellectual and Developmental Disabilities)
- All residents and staff of the home must be age 18 or older
Exclusion Criteria
- All congregate care homes in Massachusetts not operated by any of the public-sector community-based human service organizations mentioned above
Data sourced from ClinicalTrials.gov (NCT04726371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.