- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01848483
Living Well Project for Persons With AIDS
The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The overall goal of this project is to improve the health and quality of life of persons living with HIV/AIDS (PLWH). To this end, we will implement an innovative model of enhanced early integrative palliative care services (EPC) for persons diagnosed with AIDS. Patients will be recruited from either the inpatient service or outpatient infectious disease program (IDP) at the Grady Health System (GHS) in Atlanta, Georgia. The AIDS EPC Package includes use of motivational interviewing (MI) to facilitate adjustment to disease and advance care planning decision making. The project has three specific aims:
Aim 1. Conduct a research clinical trial (RCT) to examine the efficacy of the AIDS EPC Package intervention vs. standard HIV care (SOC) and compare outcomes at 12 months post baseline. Our hypothesis is that those in the AIDS EPC group will have:
i. Better clinical outcomes: a lower one year mortality, higher proportion who initiate antiretroviral therapy (ART), higher proportion with virologic suppression, higher CD4 gain, fewer opportunistic infections (OI), fewer hospitalizations, lower depression scores, and better symptom management (including cognitive dysfunction).
ii. Better psychosocial outcomes: Better coping skills, higher perceived social support, higher spirituality, higher levels of self-advocacy, lower proportion who report substance use.
iii. Better Quality of Life (QOL) and a higher proportion who report advance care planning activities: named a surrogate; set personal goals regarding life saving measures; and discussed these goals with a surrogate.
SECONDARY OUTCOMES:
Aim 2. Evaluate the cost effectiveness and cost utility of the AIDS EPC Package compared to SOC where the outcomes are valued as survival and quality-adjusted life years (QALYs) respectively.
Aim 3. Promote engagement and retention in HIV care as evidenced by attending a greater proportion of scheduled appointments and reporting higher satisfaction with care compared to SOC.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University, Nell Hodgson Woodruff School of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of AIDS (using current Centers for Disease Control and Prevention criteria)
- Detectable viral load (>1.6 log or > 40 copies per ml)
- Not currently on ART
- Age ≥18 years
- Able to speak and write English
- Able to give and understand consent
- Willing to participate in study activities.
Exclusion Criteria:
- Participants who have a Karnofsky score of 30 or less and are impaired in 5 activities of daily living (ADL) from this list: Bathing, dressing, transferring from bed or chair, walking, eating, toilet use, or grooming
- Those not HIV infected
- Minors under 18 years of age
- Unable to read or understand English
- Cognitive impairment
- Actively psychotic
- Severely depressed/suicidal
- Pose a risk of harm to themselves or others
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Other Names:
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 Antiretroviral therapy (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.
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Other: Standard of Care (SOC)
Standard of Care (SOC): Routine Infectious Disease Program HIV-care clinic appointment
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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 Antiretroviral therapy (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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of Life
Time Frame: Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
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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.
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Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Indicator: Change in Mortality at 12 Months Post-baseline
Time Frame: Baseline, up to 12 months post- baseline
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Number of deaths at 12 months post baseline
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Baseline, up to 12 months post- baseline
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Clinical Indicator: Change in Self-report Hospitalizations
Time Frame: Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
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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.
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Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline
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Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker
Time Frame: Baseline, 6 months post-baseline, and 12-months post baseline
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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".
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Baseline, 6 months post-baseline, and 12-months post baseline
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Change in Self-reported Completion of Advanced Care Planning Activities: Living Will
Time Frame: Baseline, 6 months post-baseline, and 12-months post baseline
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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".
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Baseline, 6 months post-baseline, and 12-months post baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marcia McDonnell Holstad, phD, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- IRB00059987
- NIH/NINR-1R01NR014054-01 (Other Identifier: Other)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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