Trial Outcomes & Findings for Living Well Project for Persons With AIDS (NCT NCT01848483)
NCT ID: NCT01848483
Last Updated: 2019-12-30
Results Overview
Change in Quality of Life (QOL) as measured by the McGill Quality of Life Questionnaire (MQOL) The MQOL has been widely used with persons with a life-threatening illness, including HIV/AIDS. It contains questions about physical wellbeing, physical symptoms, psychological symptoms, existential wellbeing and support in the past 2 days.A total score was computed.Scores range from 0 to 10 with higher scores indicating better perceived quality of life.
COMPLETED
NA
121 participants
Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
2019-12-30
Participant Flow
Recruitment started in June 2014 at Emory University
Participant milestones
| Measure |
AIDS EPC Package Plus MI
AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
|
Standard of Care (SOC)
Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
Standard of Care (SOC): The routine standard of care provider visit occurs in the following order. The vital signs are taken and the participant sees the nurse to review medications. The provider visits are scheduled for approximately 30 minutes, except for a new patient or patient with complex medical needs. The provider conducts a history to elicit symptoms, health problems, concerns, and a physical exam, then orders labs or immunizations; and referrals to subspecialty clinics. Medications are prescribed or renewed. The patient then receives a follow-up appointment, typically every 3 months for a stable patient. If the patient starts ART, an appointment to the nurse educator is required. Typically, the patient will have 1- 2 visits to the nurse educator to begin medications and follow-up for side-effects.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
60
|
|
Overall Study
COMPLETED
|
50
|
49
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
| Measure |
AIDS EPC Package Plus MI
AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
|
Standard of Care (SOC)
Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
Standard of Care (SOC): The routine standard of care provider visit occurs in the following order. The vital signs are taken and the participant sees the nurse to review medications. The provider visits are scheduled for approximately 30 minutes, except for a new patient or patient with complex medical needs. The provider conducts a history to elicit symptoms, health problems, concerns, and a physical exam, then orders labs or immunizations; and referrals to subspecialty clinics. Medications are prescribed or renewed. The patient then receives a follow-up appointment, typically every 3 months for a stable patient. If the patient starts ART, an appointment to the nurse educator is required. Typically, the patient will have 1- 2 visits to the nurse educator to begin medications and follow-up for side-effects.
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
8
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Incarceration
|
2
|
2
|
Baseline Characteristics
Living Well Project for Persons With AIDS
Baseline characteristics by cohort
| Measure |
AIDS EPC Package Plus MI
n=61 Participants
AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
|
Standard of Care (SOC)
n=60 Participants
Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
42.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
46 participants
n=5 Participants
|
44 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
56 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=5 Participants
|
60 participants
n=7 Participants
|
121 participants
n=5 Participants
|
|
Sexual Orientation
Straight/heterosexual
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sexual Orientation
Gay/homosexual
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sexual Orientation
Bisexual
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sexual Orientation
None of de above/unsure
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baselinePopulation: Only included participants that were able to complete the McGill Quality of Life Questionnaire at each visit.
Change in Quality of Life (QOL) as measured by the McGill Quality of Life Questionnaire (MQOL) The MQOL has been widely used with persons with a life-threatening illness, including HIV/AIDS. It contains questions about physical wellbeing, physical symptoms, psychological symptoms, existential wellbeing and support in the past 2 days.A total score was computed.Scores range from 0 to 10 with higher scores indicating better perceived quality of life.
Outcome measures
| Measure |
AIDS EPC Package Plus MI
n=61 Participants
AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
|
Standard of Care (SOC)
n=60 Participants
Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
|
|---|---|---|
|
Change in Quality of Life
Baseline
|
5.87 score on a scale
Standard Deviation 1.62
|
5.17 score on a scale
Standard Deviation 1.43
|
|
Change in Quality of Life
3 months post-baseline
|
5.68 score on a scale
Standard Deviation 1.73
|
5.06 score on a scale
Standard Deviation 1.63
|
|
Change in Quality of Life
6 months post-baseline
|
5.73 score on a scale
Standard Deviation 1.90
|
5.09 score on a scale
Standard Deviation 1.74
|
|
Change in Quality of Life
12 months post-baseline
|
6.15 score on a scale
Standard Deviation 1.73
|
5.30 score on a scale
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: Baseline, up to 12 months post- baselineNumber of deaths at 12 months post baseline
Outcome measures
| Measure |
AIDS EPC Package Plus MI
n=61 Participants
AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
|
Standard of Care (SOC)
n=60 Participants
Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
|
|---|---|---|
|
Clinical Indicator: Change in Mortality at 12 Months Post-baseline
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baselinePopulation: Participants analyzed in each time point include the ones that were able to complete the survey.
Participants completed a survey asking about hospitalizations for HIV related problems and non-HIV related health problems in the past 3 months.Results are expressed in number of participants reporting a hospital stay in the previous 3 months.
Outcome measures
| Measure |
AIDS EPC Package Plus MI
n=61 Participants
AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
|
Standard of Care (SOC)
n=60 Participants
Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
|
|---|---|---|
|
Clinical Indicator: Change in Self-report Hospitalizations
12 months post0baseline non-HIV related
|
10 Participants
|
12 Participants
|
|
Clinical Indicator: Change in Self-report Hospitalizations
Baseline HIV related
|
24 Participants
|
27 Participants
|
|
Clinical Indicator: Change in Self-report Hospitalizations
3 months post-baseline HIV related
|
11 Participants
|
12 Participants
|
|
Clinical Indicator: Change in Self-report Hospitalizations
6 months post-baseline HIV related
|
5 Participants
|
10 Participants
|
|
Clinical Indicator: Change in Self-report Hospitalizations
12 months post-baseline HIV related
|
6 Participants
|
7 Participants
|
|
Clinical Indicator: Change in Self-report Hospitalizations
Baseline non-HIV related
|
22 Participants
|
23 Participants
|
|
Clinical Indicator: Change in Self-report Hospitalizations
3 months post-baseline non-HIV related
|
15 Participants
|
15 Participants
|
|
Clinical Indicator: Change in Self-report Hospitalizations
6 months post-baseline non-HIV related
|
7 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months post-baseline, and 12-months post baselinePopulation: Participants analyzed in each time point include the ones that were able to complete the questionnaire.
The Advanced Care Planning Questionnaire contained questions about 5 aspects of advanced care planning: 1) advanced care planning decisions made; 2) how well informed a participant feels about medical decision makers and making decisions; 3) how much a person has thought about medical decision making; 4) one's perceived confidence to make medical decisions; 5) one's readiness to make medical decisions. The results focus on decisions made regarding signing papers that name a health care decision maker (yes/no). Results are reported as the number of patients who report "yes".
Outcome measures
| Measure |
AIDS EPC Package Plus MI
n=61 Participants
AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
|
Standard of Care (SOC)
n=60 Participants
Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
|
|---|---|---|
|
Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker
6 months post-baseline
|
21 Participants
|
11 Participants
|
|
Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker
Baseline
|
13 Participants
|
12 Participants
|
|
Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker
12 months post-baseline
|
22 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months post-baseline, and 12-months post baselinePopulation: Participants analyzed in each time point include the ones that were able to complete the questionnaire.
The Advanced Care Planning Questionnaire contained questions about 5 aspects of advanced care planning: 1) advanced care planning decisions made; 2) how well informed a participant feels about medical decision makers and making decisions; 3) how much a person has thought about medical decision making; 4) one's perceived confidence to make medical decisions; 5) one's readiness to make medical decisions. The results focus on decisions made regarding signing papers for either advance directives or living will (yes/no). Results are reported as the number of patients who report "yes".
Outcome measures
| Measure |
AIDS EPC Package Plus MI
n=61 Participants
AIDS EPC Package plus MI: AIDS Early Palliative Care (EPC) Package and Motivational Interviewing (MI) At least one early Palliative Care visit plus four weekly MI sessions within a 3 month period of time.
|
Standard of Care (SOC)
n=60 Participants
Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
|
|---|---|---|
|
Change in Self-reported Completion of Advanced Care Planning Activities: Living Will
Baseline
|
12 Participants
|
8 Participants
|
|
Change in Self-reported Completion of Advanced Care Planning Activities: Living Will
6 months post-baseline
|
14 Participants
|
8 Participants
|
|
Change in Self-reported Completion of Advanced Care Planning Activities: Living Will
12 months post-baseline
|
19 Participants
|
11 Participants
|
Adverse Events
AIDS EPC Package Plus MI
Standard of Care (SOC)
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