Trial Outcomes & Findings for CASA: Care and Support Access in HIV Disease (NCT NCT02136680)
NCT ID: NCT02136680
Last Updated: 2019-06-04
Results Overview
Rosenberg Self-Esteem Scale: The Rosenberg Self-Esteem Scale (RSES) is a 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is well validated and has been used in a wide variety of populations, including persons living with HIV/AIDS. All items are answered using a 4-point Likert scale format ranging from strongly agree to strongly disagree. Scores for individual items varied in range from 1 to 4, with higher scores indicative of greater self-esteem. Summary score is reflective of the mean score across all items.
COMPLETED
NA
197 participants
Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1
2019-06-04
Participant Flow
Patients were recruited between July 2014 and June of 2016. Enrollment took place in 2 separate HIV outpatient clinics where most clinic attendees were known to be HIV positive.
Potential participants were identified initially by age and gender, recruited and, if eligible, retained as study participants. We solicited referrals of eligible patients from primary care providers or designated clinic staff, and reviewed appointment schedules at both sites. Initial contact was made by the participant's primary care provider.
Participant milestones
| Measure |
Patients at Intervention Site
Staff receives CASA Education:
The intervention is to deliver staff education and training for early integration of palliative skills with ongoing HIV management. Palliative skills for individuals who have little, or no, formal training in palliative care focus on care strategies to relieve suffering and promote quality of life for persons with any chronic illness regardless of the life expectancy. The educational intervention is based upon 8 years' experience in training clinicians how to care for HIV patients using a "Train the Trainer" method and quality improvement to integrate palliative skills with HIV care and treatment. The model used for this training is standard in chronic disease management and was used by the University of Maryland, Baltimore research team for 8 years in African settings. These skills can be applied to any chronic illness.
|
Patients at CONTROL Site
Staff does not receive CASA Education:
Patients at this site receive their usual care.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
85
|
|
Overall Study
Interview 1
|
112
|
85
|
|
Overall Study
Interview 2
|
97
|
70
|
|
Overall Study
Interview 3
|
80
|
56
|
|
Overall Study
COMPLETED
|
80
|
56
|
|
Overall Study
NOT COMPLETED
|
32
|
29
|
Reasons for withdrawal
| Measure |
Patients at Intervention Site
Staff receives CASA Education:
The intervention is to deliver staff education and training for early integration of palliative skills with ongoing HIV management. Palliative skills for individuals who have little, or no, formal training in palliative care focus on care strategies to relieve suffering and promote quality of life for persons with any chronic illness regardless of the life expectancy. The educational intervention is based upon 8 years' experience in training clinicians how to care for HIV patients using a "Train the Trainer" method and quality improvement to integrate palliative skills with HIV care and treatment. The model used for this training is standard in chronic disease management and was used by the University of Maryland, Baltimore research team for 8 years in African settings. These skills can be applied to any chronic illness.
|
Patients at CONTROL Site
Staff does not receive CASA Education:
Patients at this site receive their usual care.
|
|---|---|---|
|
Overall Study
No Longer Interested
|
1
|
1
|
|
Overall Study
No longer receiving care at clinic
|
3
|
5
|
|
Overall Study
Moved away
|
5
|
4
|
|
Overall Study
Unable to schedule
|
17
|
16
|
|
Overall Study
Study ended before interview due
|
6
|
3
|
Baseline Characteristics
There was insufficient information to categorize 2 participants.
Baseline characteristics by cohort
| Measure |
Patients at Intervention Site
n=112 Participants
Staff receives CASA Education: Basic palliative competencies for outpatient use.
|
Patients at CONTROL Site
n=85 Participants
Staff does not receive CASA Education: Patients at this site receive their usual care.
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 4.2 • n=112 Participants
|
30 years
STANDARD_DEVIATION 3.5 • n=85 Participants
|
29 years
STANDARD_DEVIATION 3.9 • n=197 Participants
|
|
Age, Customized
18 - 25
|
29 Participants
n=112 Participants
|
11 Participants
n=85 Participants
|
40 Participants
n=197 Participants
|
|
Age, Customized
26 - 30
|
44 Participants
n=112 Participants
|
39 Participants
n=85 Participants
|
83 Participants
n=197 Participants
|
|
Age, Customized
31 - 35
|
39 Participants
n=112 Participants
|
35 Participants
n=85 Participants
|
74 Participants
n=197 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=112 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=197 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=112 Participants
|
85 Participants
n=85 Participants
|
197 Participants
n=197 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
93 Participants
n=112 Participants
|
61 Participants
n=85 Participants
|
154 Participants
n=197 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
11 Participants
n=112 Participants
|
7 Participants
n=85 Participants
|
18 Participants
n=197 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
2 Participants
n=112 Participants
|
9 Participants
n=85 Participants
|
11 Participants
n=197 Participants
|
|
Race/Ethnicity, Customized
Other, non-Hispanic
|
0 Participants
n=112 Participants
|
4 Participants
n=85 Participants
|
4 Participants
n=197 Participants
|
|
Race/Ethnicity, Customized
Multiracial, non-Hispanic
|
6 Participants
n=112 Participants
|
4 Participants
n=85 Participants
|
10 Participants
n=197 Participants
|
|
Region of Enrollment
United States
|
112 Participants
n=112 Participants
|
85 Participants
n=85 Participants
|
197 Participants
n=197 Participants
|
|
HIV Risk Group
Sex
|
89 Participants
n=110 Participants • There was insufficient information to categorize 2 participants.
|
63 Participants
n=85 Participants • There was insufficient information to categorize 2 participants.
|
152 Participants
n=195 Participants • There was insufficient information to categorize 2 participants.
|
|
HIV Risk Group
Sex (Female Only)
|
3 Participants
n=110 Participants • There was insufficient information to categorize 2 participants.
|
0 Participants
n=85 Participants • There was insufficient information to categorize 2 participants.
|
3 Participants
n=195 Participants • There was insufficient information to categorize 2 participants.
|
|
HIV Risk Group
IV Drug Usage
|
2 Participants
n=110 Participants • There was insufficient information to categorize 2 participants.
|
1 Participants
n=85 Participants • There was insufficient information to categorize 2 participants.
|
3 Participants
n=195 Participants • There was insufficient information to categorize 2 participants.
|
|
HIV Risk Group
Transfusion
|
1 Participants
n=110 Participants • There was insufficient information to categorize 2 participants.
|
0 Participants
n=85 Participants • There was insufficient information to categorize 2 participants.
|
1 Participants
n=195 Participants • There was insufficient information to categorize 2 participants.
|
|
HIV Risk Group
Sex and IV Drug Usage
|
2 Participants
n=110 Participants • There was insufficient information to categorize 2 participants.
|
6 Participants
n=85 Participants • There was insufficient information to categorize 2 participants.
|
8 Participants
n=195 Participants • There was insufficient information to categorize 2 participants.
|
|
HIV Risk Group
Sex, IV Drug Usage and Transfusion
|
9 Participants
n=110 Participants • There was insufficient information to categorize 2 participants.
|
7 Participants
n=85 Participants • There was insufficient information to categorize 2 participants.
|
16 Participants
n=195 Participants • There was insufficient information to categorize 2 participants.
|
|
HIV Risk Group
Other
|
1 Participants
n=110 Participants • There was insufficient information to categorize 2 participants.
|
1 Participants
n=85 Participants • There was insufficient information to categorize 2 participants.
|
2 Participants
n=195 Participants • There was insufficient information to categorize 2 participants.
|
|
HIV Risk Group
Don't know
|
3 Participants
n=110 Participants • There was insufficient information to categorize 2 participants.
|
7 Participants
n=85 Participants • There was insufficient information to categorize 2 participants.
|
10 Participants
n=195 Participants • There was insufficient information to categorize 2 participants.
|
|
IV Drug Usage Risk Factor
No
|
97 Participants
n=110 Participants • There was insufficient information to categorize 2 participants.
|
71 Participants
n=85 Participants • There was insufficient information to categorize 2 participants.
|
168 Participants
n=195 Participants • There was insufficient information to categorize 2 participants.
|
|
IV Drug Usage Risk Factor
Yes
|
13 Participants
n=110 Participants • There was insufficient information to categorize 2 participants.
|
14 Participants
n=85 Participants • There was insufficient information to categorize 2 participants.
|
27 Participants
n=195 Participants • There was insufficient information to categorize 2 participants.
|
|
HIV Treatment Regimen
No Treatment
|
1 Participants
n=112 Participants
|
1 Participants
n=85 Participants
|
2 Participants
n=197 Participants
|
|
HIV Treatment Regimen
1 Pill/Day
|
91 Participants
n=112 Participants
|
53 Participants
n=85 Participants
|
144 Participants
n=197 Participants
|
|
HIV Treatment Regimen
2 or More Pills/Day
|
19 Participants
n=112 Participants
|
28 Participants
n=85 Participants
|
47 Participants
n=197 Participants
|
|
HIV Treatment Regimen
No Medical Info
|
1 Participants
n=112 Participants
|
3 Participants
n=85 Participants
|
4 Participants
n=197 Participants
|
|
Viral Load Suppressed
Unknown
|
16 Participants
n=112 Participants
|
4 Participants
n=85 Participants
|
20 Participants
n=197 Participants
|
|
Viral Load Suppressed
No
|
39 Participants
n=112 Participants
|
31 Participants
n=85 Participants
|
70 Participants
n=197 Participants
|
|
Viral Load Suppressed
Yes
|
57 Participants
n=112 Participants
|
50 Participants
n=85 Participants
|
107 Participants
n=197 Participants
|
|
Adherence
Not adherent
|
53 Participants
n=112 Participants
|
39 Participants
n=85 Participants
|
92 Participants
n=197 Participants
|
|
Adherence
Adherent
|
59 Participants
n=112 Participants
|
45 Participants
n=85 Participants
|
104 Participants
n=197 Participants
|
|
Adherence
Missing Info
|
0 Participants
n=112 Participants
|
1 Participants
n=85 Participants
|
1 Participants
n=197 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1Population: Baseline, 1st Follow-up \[FU1\]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up \[FU2\]: 4-5 mos post FU1
Rosenberg Self-Esteem Scale: The Rosenberg Self-Esteem Scale (RSES) is a 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is well validated and has been used in a wide variety of populations, including persons living with HIV/AIDS. All items are answered using a 4-point Likert scale format ranging from strongly agree to strongly disagree. Scores for individual items varied in range from 1 to 4, with higher scores indicative of greater self-esteem. Summary score is reflective of the mean score across all items.
Outcome measures
| Measure |
Patients at Intervention Site
n=112 Participants
Staff receives CASA Education: Basic palliative competencies for outpatient use.
|
Patients at CONTROL Site
n=85 Participants
Staff does not receive CASA Education: Patients at this site receive their usual care.
|
|---|---|---|
|
Mental Health: Rosenberg Self-Esteem Scale
Baseline
|
3.2 [Units on a scale]
Standard Deviation 0.6
|
3.2 [Units on a scale]
Standard Deviation 0.6
|
|
Mental Health: Rosenberg Self-Esteem Scale
FU1
|
3.2 [Units on a scale]
Standard Deviation 0.5
|
3.1 [Units on a scale]
Standard Deviation 0.6
|
|
Mental Health: Rosenberg Self-Esteem Scale
FU2
|
3.1 [Units on a scale]
Standard Deviation 0.6
|
3.0 [Units on a scale]
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1Population: Baseline, 1st Follow-up \[FU1\]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up \[FU2\]: 4-5 mos post FU1
The McGill Quality of Life Questionnaire (MQOL) is a measure of quality of life for persons with advanced/serious illness. The MQOL consists of 16-items plus a global quality of life item, each with a 2-day time frame and has demonstrated validity and other measurement properties for use with palliative care populations. There are four subscales (psychological symptoms, existential well-being, support, and physical symptoms) and a summary quality of life score that weights these domains equally. Items are scored zero (worst) to 10 (excellent).
Outcome measures
| Measure |
Patients at Intervention Site
n=112 Participants
Staff receives CASA Education: Basic palliative competencies for outpatient use.
|
Patients at CONTROL Site
n=85 Participants
Staff does not receive CASA Education: Patients at this site receive their usual care.
|
|---|---|---|
|
Quality of Life: McGill Quality of Life Scale
Baseline: Global QOL Item
|
6.9 [Units on a scale]
Standard Deviation 2.4
|
6.7 [Units on a scale]
Standard Deviation 2.6
|
|
Quality of Life: McGill Quality of Life Scale
Baseline: Summary QOL Score
|
7.0 [Units on a scale]
Standard Deviation 2.1
|
6.9 [Units on a scale]
Standard Deviation 2.1
|
|
Quality of Life: McGill Quality of Life Scale
FU1: Global QOL Item
|
7.3 [Units on a scale]
Standard Deviation 2.3
|
7.1 [Units on a scale]
Standard Deviation 2.5
|
|
Quality of Life: McGill Quality of Life Scale
FU1: Summary QOL Score
|
7.0 [Units on a scale]
Standard Deviation 2.2
|
6.9 [Units on a scale]
Standard Deviation 2.3
|
|
Quality of Life: McGill Quality of Life Scale
FU2: Global QOL Item
|
7.2 [Units on a scale]
Standard Deviation 2.5
|
6.4 [Units on a scale]
Standard Deviation 2.8
|
|
Quality of Life: McGill Quality of Life Scale
FU2: Summary QOL Score
|
7.1 [Units on a scale]
Standard Deviation 2.3
|
6.2 [Units on a scale]
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1Population: Baseline, 1st Follow-up \[FU1\]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up \[FU2\]: 4-5 mos post FU1
The Palliative Outcome Scale (POS) is a 10-item multidimensional well-being tool well validated for use in palliative care settings that measures the 3-day period prevalence and intensity of pain, other physical symptoms, patient anxiety, family/friends anxiety, information sufficiency, sharing feelings with family/friends, feeling life is worthwhile, self-worth, wasted time, and personal affairs, i.e. the physical/social/spiritual/psychological problems in line with the World Health Organization (WHO) definition of palliative care. Eight of the 10 items use a five-point Likert-like scale, and the remaining two items use a three-point scale. Scores for respondents' ratings on all items can range from 0 (indicating no problem) to 4 (indicating a very severe or overwhelming problem). The overall profile score is the sum of the scores from each of the 10 questions and can therefore range from zero to 40. Higher scores are indicative of greater problems.
Outcome measures
| Measure |
Patients at Intervention Site
n=112 Participants
Staff receives CASA Education: Basic palliative competencies for outpatient use.
|
Patients at CONTROL Site
n=85 Participants
Staff does not receive CASA Education: Patients at this site receive their usual care.
|
|---|---|---|
|
Health-Related Quality of Life in Palliative Care: Palliative Outcome Scale
Baseline
|
8.9 [Units on a scale]
Standard Deviation 7.0
|
8.4 [Units on a scale]
Standard Deviation 6.6
|
|
Health-Related Quality of Life in Palliative Care: Palliative Outcome Scale
FU1
|
8.4 [Units on a scale]
Standard Deviation 6.4
|
9.5 [Units on a scale]
Standard Deviation 7.0
|
|
Health-Related Quality of Life in Palliative Care: Palliative Outcome Scale
FU2
|
8.5 [Units on a scale]
Standard Deviation 7.1
|
8.5 [Units on a scale]
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1Population: Baseline, 1st Follow-up \[FU1\]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up \[FU2\]: 4-5 mos post FU1. There were 11 cases for which viral load information was missing from the patient medical records.
Patient is HIV viral load suppressed, as abstracted from patient electronic medical records.
Outcome measures
| Measure |
Patients at Intervention Site
n=102 Participants
Staff receives CASA Education: Basic palliative competencies for outpatient use.
|
Patients at CONTROL Site
n=84 Participants
Staff does not receive CASA Education: Patients at this site receive their usual care.
|
|---|---|---|
|
Viral Load Suppressed
Baseline · Not Virally Suppressed
|
43 Participants
|
32 Participants
|
|
Viral Load Suppressed
Baseline · Viral Load Suppressed
|
59 Participants
|
52 Participants
|
|
Viral Load Suppressed
FU1 · Not Virally Suppressed
|
25 Participants
|
20 Participants
|
|
Viral Load Suppressed
FU1 · Viral Load Suppressed
|
48 Participants
|
44 Participants
|
|
Viral Load Suppressed
FU2 · Not Virally Suppressed
|
18 Participants
|
19 Participants
|
|
Viral Load Suppressed
FU2 · Viral Load Suppressed
|
50 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1Population: Baseline, 1st Follow-up \[FU1\]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up \[FU2\]: 4-5 mos post FU1. There was 1 case for which adherence data was missing for the patient.
Self-reported adherence over the past month by an item from the Adult Aids Clinical Trials Group (AACTG) questionnaire.
Outcome measures
| Measure |
Patients at Intervention Site
n=112 Participants
Staff receives CASA Education: Basic palliative competencies for outpatient use.
|
Patients at CONTROL Site
n=84 Participants
Staff does not receive CASA Education: Patients at this site receive their usual care.
|
|---|---|---|
|
Adherence
FU1 · Adherent
|
55 Participants
|
29 Participants
|
|
Adherence
Baseline · Not Adherent
|
53 Participants
|
39 Participants
|
|
Adherence
Baseline · Adherent
|
59 Participants
|
45 Participants
|
|
Adherence
FU1 · Not Adherent
|
42 Participants
|
41 Participants
|
|
Adherence
FU2 · Not Adherent
|
34 Participants
|
33 Participants
|
|
Adherence
FU2 · Adherent
|
46 Participants
|
22 Participants
|
Adverse Events
Patients at Intervention Site
Patients at CONTROL Site
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Carla Alexander
University of Maryland Baltimore, School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place