Trial Outcomes & Findings for Brief COVID-19 Intervention for People With Serious Mental Illness and Co-Morbid Medical Conditions (NCT NCT05467982)
NCT ID: NCT05467982
Last Updated: 2024-07-12
Results Overview
change in status from baseline to follow up, receipt of vaccination or not.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
164 participants
Primary outcome timeframe
Baseline to 12 Weeks
Results posted on
2024-07-12
Participant Flow
All enrolled participants were actively participating in the parent project and maintained the randomization status from the parent study for the COVID intervention (see NCT03966870).
Participant milestones
| Measure |
Integrated Illness Management and Recovery (I-IMR) PLUS COVID-19 ENHANCEMENT:
In addition to the primary intervention (Integrated Illness Management and Recovery), participants received 3 additional COVID-19 related educational/skills training sessions provided individually, remotely by I-IMR Specialists.
Integrated Illness Management and Recovery: Education and skills training groups on illness management of chronic medical and psychiatric illness. Subsample of 75 will also receive COVID-specific Integrated Illness Management and Recovery module.
|
Stanford Chronic Disease Self-Management Program (CDSMP) ONLY:
No additional COVID-19 intervention was provided to this group. These participants only received the primary disease management intervention (CDSMP)
Chronic Disease Self-Management Program: Education and skills training groups on illness management of chronic conditions
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
82
|
|
Overall Study
COMPLETED
|
77
|
80
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Integrated Illness Management and Recovery (I-IMR) PLUS COVID-19 ENHANCEMENT:
In addition to the primary intervention (Integrated Illness Management and Recovery), participants received 3 additional COVID-19 related educational/skills training sessions provided individually, remotely by I-IMR Specialists.
Integrated Illness Management and Recovery: Education and skills training groups on illness management of chronic medical and psychiatric illness. Subsample of 75 will also receive COVID-specific Integrated Illness Management and Recovery module.
|
Stanford Chronic Disease Self-Management Program (CDSMP) ONLY:
No additional COVID-19 intervention was provided to this group. These participants only received the primary disease management intervention (CDSMP)
Chronic Disease Self-Management Program: Education and skills training groups on illness management of chronic conditions
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
Baseline Characteristics
Brief COVID-19 Intervention for People With Serious Mental Illness and Co-Morbid Medical Conditions
Baseline characteristics by cohort
| Measure |
Integrated Illness Management and Recovery (I-IMR) PLUS COVID-19 ENHANCEMENT:
n=80 Participants
In addition to the primary intervention (Integrated Illness Management and Recovery), participants received 3 additional COVID-19 related educational/skills training sessions provided individually, remotely by I-IMR Specialists.
Integrated Illness Management and Recovery: Education and skills training groups on illness management of chronic medical and psychiatric illness. Subsample of 75 will also receive COVID-specific Integrated Illness Management and Recovery module.
|
Stanford Chronic Disease Self-Management Program (CDSMP) ONLY:
n=82 Participants
No additional COVID-19 intervention was provided to this group. These participants only received the primary disease management intervention (CDSMP)
Chronic Disease Self-Management Program: Education and skills training groups on illness management of chronic conditions
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
78 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
49.1 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
53 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender/Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 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
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
82 participants
n=7 Participants
|
162 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 Weekschange in status from baseline to follow up, receipt of vaccination or not.
Outcome measures
| Measure |
Integrated Illness Management and Recovery (I-IMR) PLUS COVID-19 ENHANCEMENT:
n=80 Participants
In addition to the primary intervention (Integrated Illness Management and Recovery), participants received 3 additional COVID-19 related educational/skills training sessions provided individually, remotely by I-IMR Specialists.
Integrated Illness Management and Recovery: Education and skills training groups on illness management of chronic medical and psychiatric illness. Subsample of 75 will also receive COVID-specific Integrated Illness Management and Recovery module.
|
Stanford Chronic Disease Self-Management Program (CDSMP) ONLY:
n=82 Participants
No additional COVID-19 intervention was provided to this group. These participants only received the primary disease management intervention (CDSMP)
Chronic Disease Self-Management Program: Education and skills training groups on illness management of chronic conditions
|
|---|---|---|
|
Number of Participants Who Received COVID-19 Vaccine
|
56 Participants
|
50 Participants
|
Adverse Events
Integrated Illness Management and Recovery (I-IMR) PLUS COVID-19 ENHANCEMENT:
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stanford Chronic Disease Self-Management Program (CDSMP) ONLY:
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
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