Trial Outcomes & Findings for In-person vs. Remote Wellness Support (NCT NCT04526067)
NCT ID: NCT04526067
Last Updated: 2024-09-05
Results Overview
Proportion of subjects who dropped out of treatment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2024-09-05
Participant Flow
Participants were 56 members of a large Managed Medicaid program in Texas
Participant milestones
| Measure |
R-CAT
While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. Therefore, 21 individuals were simply assigned to R-CAT and 14 received R-CAT based upon preference. This treatment group provided Cognitive Adaptation Remotely via secure video conference, sent text message reminders, delivered environmental supports by mail. Environmental supports targeted medication and appointment follow-through, independent living skills and organization, and socialization. Supports were set up on virtual visits conducted weekly.
|
CAT Cognitive Adaptation Training
While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. 21 participants received CAT based upon preference for CAT versus R-CAT. CAT involved in person assessment and establishing supports in the home for medication follow-through, independent living skills/organization and socialization.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
21
|
|
Overall Study
COMPLETED
|
35
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In-person vs. Remote Wellness Support
Baseline characteristics by cohort
| Measure |
Cognitive Adaptation Training (CAT)
n=21 Participants
A home delivered adherence intervention used by managed care used to improve outcomes across multiple conditions.
CAT: An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home on weekly visits to cue adaptive behaviors and establish healthy habits.
|
Remote Cognitive Adaptation Training (R-CAT)
n=35 Participants
A primarily remotely delivered workable adherence intervention used by managed care used to improve outcomes across multiple conditions.
R-CAT: An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home using remote weekly visits to cue adaptive behaviors and establish healthy habits.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
44.9 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Social and Occupational Functioning Scale score
|
39.1 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
44.9 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
42.72 units on a scale
STANDARD_DEVIATION 2.09 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: examined descriptive statistics for proportion of drop outs by group
Proportion of subjects who dropped out of treatment
Outcome measures
| Measure |
R-CAT
n=35 Participants
While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. Therefore, 21 individuals were simply assigned to R-CAT and 14 received R-CAT based upon preference. This treatment group provided Cognitive Adaptation Remotely via secure video conference, sent text message reminders, delivered environmental supports by mail. Environmental supports targeted medication and appointment follow-through, independent living skills and organization, and socialization. Supports were set up on virtual visits conducted weekly.
|
CAT Cognitive Adaptation Training
n=21 Participants
While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. 21 participants received CAT based upon preference for CAT versus R-CAT. CAT involved in person assessment and establishing supports in the home for medication follow-through, independent living skills/organization and socialization.
|
|---|---|---|
|
Acceptance of Intervention-Number of Participants Who Dropped Out of Treatment
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: IIT population with baseline and at least 1 follow up
Adherence proportion is calculated as the number of pills missing and presumed taken/ the number of pills prescribed for the time period. Monthly checks will be performed.
Outcome measures
| Measure |
R-CAT
n=35 Participants
While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. Therefore, 21 individuals were simply assigned to R-CAT and 14 received R-CAT based upon preference. This treatment group provided Cognitive Adaptation Remotely via secure video conference, sent text message reminders, delivered environmental supports by mail. Environmental supports targeted medication and appointment follow-through, independent living skills and organization, and socialization. Supports were set up on virtual visits conducted weekly.
|
CAT Cognitive Adaptation Training
n=21 Participants
While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. 21 participants received CAT based upon preference for CAT versus R-CAT. CAT involved in person assessment and establishing supports in the home for medication follow-through, independent living skills/organization and socialization.
|
|---|---|---|
|
Medication Adherence
|
.21 proportion of pills taken
Standard Error 0.05
|
.10 proportion of pills taken
Standard Error 0.08
|
PRIMARY outcome
Timeframe: Baseline to 6 months note that repeated measures analysis was also usedPopulation: ITT population with at least a baseline and one follow-up assessment
Functional outcome will be rated using the Social and Occupational Functioning Scale (SOFAS).The SOFAS rates functioning on a scale from 0 to 100 based upon all the data collected in the assessment. Higher scores reflect better functional outcome. The value reported is the the 6 month value minus the baseline value\>
Outcome measures
| Measure |
R-CAT
n=35 Participants
While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. Therefore, 21 individuals were simply assigned to R-CAT and 14 received R-CAT based upon preference. This treatment group provided Cognitive Adaptation Remotely via secure video conference, sent text message reminders, delivered environmental supports by mail. Environmental supports targeted medication and appointment follow-through, independent living skills and organization, and socialization. Supports were set up on virtual visits conducted weekly.
|
CAT Cognitive Adaptation Training
n=21 Participants
While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. 21 participants received CAT based upon preference for CAT versus R-CAT. CAT involved in person assessment and establishing supports in the home for medication follow-through, independent living skills/organization and socialization.
|
|---|---|---|
|
Functional Outcome
|
1.88 score on a scale
Standard Deviation 1.72
|
6.48 score on a scale
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: Baseline to 6 months (note that repeated measures analysis examined change over time as well.Population: IIT analysis of all with baseline and at least 1 follow up assessment.
A 36-item scale assessing three types of habit taking medication, following a schedule or calendar, and grooming (specifically brushing teeth. 12 items assessed each behavior; The SRHI looks at 1) automaticity , 2) frequency, and 3) relevance to self-identity for each behavior. There are 12 items for each sub-scale scored 1-7 (total possible range is 12-84 for each of the 3 scales). A total Habit score will be computed by calculating the mean of the 3 sub-scales to give a value between 12 and 84. Lower mean scores indicate greater habit strength.
Outcome measures
| Measure |
R-CAT
n=35 Participants
While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. Therefore, 21 individuals were simply assigned to R-CAT and 14 received R-CAT based upon preference. This treatment group provided Cognitive Adaptation Remotely via secure video conference, sent text message reminders, delivered environmental supports by mail. Environmental supports targeted medication and appointment follow-through, independent living skills and organization, and socialization. Supports were set up on virtual visits conducted weekly.
|
CAT Cognitive Adaptation Training
n=21 Participants
While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. 21 participants received CAT based upon preference for CAT versus R-CAT. CAT involved in person assessment and establishing supports in the home for medication follow-through, independent living skills/organization and socialization.
|
|---|---|---|
|
Self-Report Habit Index (SRHI)
|
6.6 score on a scale
Standard Deviation 2.69
|
7.6 score on a scale
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: ITT sample with baseline and at least one follow up. Also conducted repeated measures analysis.
Change in symptoms assess by a trained rater using the Brief Psychiatric Rating Scale-Expanded Version (BPRS-E). The scale is used to rate the subjects using 24 items, each to be rated in a 7-point scale of severity ranging from NA (not assessed), then 1-7, with 7 being the most severe. The possible range of scores is from 1 to 168 with a total score reflects an overall level of symptomology, with 168, being the maximum score, with the most symptoms present. The value reported is the 6 month value minus the baseline value.
Outcome measures
| Measure |
R-CAT
n=35 Participants
While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. Therefore, 21 individuals were simply assigned to R-CAT and 14 received R-CAT based upon preference. This treatment group provided Cognitive Adaptation Remotely via secure video conference, sent text message reminders, delivered environmental supports by mail. Environmental supports targeted medication and appointment follow-through, independent living skills and organization, and socialization. Supports were set up on virtual visits conducted weekly.
|
CAT Cognitive Adaptation Training
n=21 Participants
While the original design called for participants to either be randomized to CAT or R-CAT or to indicate a preference and be assigned to these groups, due to risk of COVID-19 infection during the pandemic, only R-CAT could be offered during the early parts of the trial. 21 participants received CAT based upon preference for CAT versus R-CAT. CAT involved in person assessment and establishing supports in the home for medication follow-through, independent living skills/organization and socialization.
|
|---|---|---|
|
Symptomatology
|
13.7 score on a scale
Standard Deviation 2.5
|
6.82 score on a scale
Standard Deviation 2.03
|
Adverse Events
R-CAT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CAT Cognitive Adaptation Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dawn Velligan, PhD
University of Texas Health Science Center in San Antonio
Phone: 210-567-5508
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place