Trial · NCT04726371
Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings
NCT04726371, Not applicable, Completed, Massachusetts General Hospital; results first posted 2025-02-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings. Trials, record NCT04726371. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04726371
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Best Practices to Prevent COVID-19 Illness in Staff and People With Serious Mental Illness and Developmental Disabilities in Congregate Living Settings
- NCT number
- NCT04726371
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 415 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Intellectual Disability, Developmental Disability, Axis I Diagnosis, Mental Illness, Covid19, Coronavirus
- Interventions
- Generic Best Practices, Tailored Best Practices
- First posted
- 2021-01-27
- Last updated
- 2025-02-12
- Results first posted
- 2025-02-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | New COVID-19 Group Home Incidence | The outcome was measured at baseline, 3-, 6-, 9-, 12-, and 15-months post-baseline. | New laboratory-confirmed COVID-19 cases among residents and staff. Measured as new cases per 100 person-months. |
| Primary | Best Practices Fidelity | The outcome will be measured at baseline, 3-, 6-, 9-, 12-, and 15-months post-baseline. | Best Practices Fidelity is measured by the COVID-19 Best Practices Fidelity Measure developed for this project and refined with input from stakeholders on relevant COVID-19-prevention policies (e.g. number of staff and residents participating in recommended screening, masking, hand washing, and vaccination in the group homes). The Fidelity scale was developed by operationally defining 2-4 items to assess each measure, with items scored on a 5- to 6-point continuum with a rating of 5 or 6 indicating full adherence to the fidelity standard and 1 indicating complete lack of adherence. A home's overall, continuous fidelity score was calculated by averaging measure-specific scores by time period. Each active measure was given equal weight. The percentage scores for each of these measures were then averaged together. The overall fidelity score ranged from a low of 20% (1 out of 5 on each item) to a high of 100% (5 out of 5 on each item). |
| Primary | Full COVID-19 Vaccination Status Among Residents | Assessed from April 1 to the date of vaccination (up to June 30, 2022), up to 15 months for each participant. | This outcome measure reflects the number of group home (GH) residents who were not fully vaccinated at the beginning of the study (by March 31, 2021) but became fully vaccinated during the study period. Individual-level dates of COVID-19 vaccinations were obtained from records maintained by GH organizations. A person was considered to be fully vaccinated when they received the full dosage of initial immunization(s) as recommended by the CDC during the study, either two initial doses of the Pfizer or Moderna vaccine or one dose of the Johnson \& Johnson vaccine. Baseline vaccination rates were established from January 1, 2021, to March 31, 2021. |
| Primary | Full COVID-19 Vaccination Status Among Staff | Assessed from April 1 to the date of vaccination (up to June 30, 2022), up to 15 months for each participant. | This outcome measure reflects the number of group home (GH) staff who were not fully vaccinated at the beginning of the study (by March 31, 2021) but became fully vaccinated during the study period. Individual-level dates of COVID-19 vaccinations were obtained from records maintained by GH organizations. A person was considered to be fully vaccinated when they received the full dosage of initial immunization(s) as recommended by the CDC during the study, either two initial doses of the Pfizer or Moderna vaccine or one dose of the Johnson \& Johnson vaccine. Baseline vaccination rates were established from January 1, 2021, to March 31, 2021. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | New COVID-19 Group Home Incidence | The outcome was measured at baseline, 3-, 6-, 9-, 12-, and 15-months post-baseline. | One group home in the GBP arm closed between the 6- and 9-month follow-up periods. The BL sample size here is different than the BL descriptive table. For the BL descriptive table, we assigned participants on an intent-to-treat basis in order to avoid overlap. However, for our analysis, participant allocation was based on the home that they lived or worked in during the study period. Since some staff worked in multiple homes across both arms, the samples are not mutually exclusive. | New COVID-19 cases per 100 person-months | MEAN |
| PRIMARY | Best Practices Fidelity | The outcome will be measured at baseline, 3-, 6-, 9-, 12-, and 15-months post-baseline. | Best Practices Fidelity was measured using a voluntary survey completed only by group home Program Directors who consented to participate at each time point. Participant counts are limited to individuals in homes whose Program Directors contributed survey responses during each time period. Participants were assigned to homes based on where they lived or worked during the study period. Since some staff worked in multiple homes across both arms, the samples are not mutually exclusive. | score on a scale | MEAN |
| PRIMARY | Full COVID-19 Vaccination Status Among Residents | Assessed from April 1 to the date of vaccination (up to June 30, 2022), up to 15 months for each participant. | Residents with SMI or ID/DD who were not fully vaccinated by March 31, 2021. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Full COVID-19 Vaccination Status Among Staff | Assessed from April 1 to the date of vaccination (up to June 30, 2022), up to 15 months for each participant. | Staff who were not fully vaccinated by March 31, 2021. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| New COVID-19 Group Home Incidence | Generic Best Practices (GBP) | Baseline | 1.61 | 95% Confidence Interval 1.38 to 1.84 | New COVID-19 cases per 100 person-months |
| New COVID-19 Group Home Incidence | Tailored Best Practices (TBP) | Baseline | 1.40 | 95% Confidence Interval 1.20 to 1.60 | New COVID-19 cases per 100 person-months |
| New COVID-19 Group Home Incidence | Generic Best Practices (GBP) | 3-month follow-up | 0.16 | 95% Confidence Interval 0.05 to 0.27 | New COVID-19 cases per 100 person-months |
| New COVID-19 Group Home Incidence | Tailored Best Practices (TBP) | 3-month follow-up | 0.09 | 95% Confidence Interval 0.01 to 0.17 | New COVID-19 cases per 100 person-months |
| New COVID-19 Group Home Incidence | Generic Best Practices (GBP) | 6-month follow-up | 0.69 | 95% Confidence Interval 0.48 to 0.90 | New COVID-19 cases per 100 person-months |
| New COVID-19 Group Home Incidence | Tailored Best Practices (TBP) | 6-month follow-up | 0.55 | 95% Confidence Interval 0.40 to 0.70 | New COVID-19 cases per 100 person-months |
| New COVID-19 Group Home Incidence | Generic Best Practices (GBP) | 9-month follow-up | 2.27 | 95% Confidence Interval 2.04 to 2.50 | New COVID-19 cases per 100 person-months |
| New COVID-19 Group Home Incidence | Tailored Best Practices (TBP) | 9-month follow-up | 2.35 | 95% Confidence Interval 2.12 to 2.59 | New COVID-19 cases per 100 person-months |
| New COVID-19 Group Home Incidence | Generic Best Practices (GBP) | 12-month follow-up | 5.67 | 95% Confidence Interval 5.38 to 5.95 | New COVID-19 cases per 100 person-months |
| New COVID-19 Group Home Incidence | Tailored Best Practices (TBP) | 12-month follow-up | 5.75 | 95% Confidence Interval 5.45 to 6.06 | New COVID-19 cases per 100 person-months |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Generic Best Practices (GBP) | 4,836 | 207 |
| Overall Study | STARTED | Tailored Best Practices (TBP) | 4,538 | 208 |
| Overall Study | Residents (Vaccination Analysis) | Generic Best Practices (GBP) | 492 | 207 |
| Overall Study | Residents (Vaccination Analysis) | Tailored Best Practices (TBP) | 407 | 208 |
| Overall Study | Staff (Vaccination Analysis) | Generic Best Practices (GBP) | 836 | 207 |
| Overall Study | Staff (Vaccination Analysis) | Tailored Best Practices (TBP) | 836 | 208 |
| Overall Study | COMPLETED | Generic Best Practices (GBP) | 3,481 | 206 |
| Overall Study | COMPLETED | Tailored Best Practices (TBP) | 3,262 | 208 |
| Overall Study | NOT COMPLETED | Generic Best Practices (GBP) | 1,355 | 1 |
| Overall Study | NOT COMPLETED | Tailored Best Practices (TBP) | 1,276 | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Inpatient hospitalization due to COVID-19 infection | Infections and infestations | Generic Best Practices (GBP) | 16 | 2,059 | |
| serious | Inpatient hospitalization due to COVID-19 infection | Infections and infestations | Tailored Best Practices (TBP) | 11 | 1,777 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Generic Best Practices (GBP) | 1 | 2,059 |
| Total, all-cause mortality | Tailored Best Practices (TBP) | 1 | 1,777 |
| Total, other adverse events | Generic Best Practices (GBP) | 0 | 2,059 |
| Total, other adverse events | Tailored Best Practices (TBP) | 0 | 1,777 |
| Total, serious adverse events | Generic Best Practices (GBP) | 16 | 2,059 |
| Total, serious adverse events | Tailored Best Practices (TBP) | 11 | 1,777 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Generic Best Practices (GBP) vs Tailored Best Practices (TBP): Full COVID-19 Vaccination Status Among Residents | Trial comparisons |
| Generic Best Practices (GBP) vs Tailored Best Practices (TBP): Full COVID-19 Vaccination Status Among Staff | Trial comparisons |
| Generic Best Practices (GBP) vs Tailored Best Practices (TBP): deaths from any cause | Trial comparisons |
| Generic Best Practices (GBP) vs Tailored Best Practices (TBP): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04726371
GET https://conductscience.org/api/trials/v1/NCT04726371/results?page=2