Living Well Project for Persons With AIDS
The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University, Nell Hodgson Woodruff School of Nursing
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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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其他名称：
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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其他：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in Quality of Life
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Clinical Indicator: Change in Mortality at 12 Months Post-baseline
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Marcia McDonnell Holstad, phD、Emory University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
AIDS EPC Package plus MI的临床试验
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University Hospital, GhentGC Europe完全的
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University Hospital, GhentGC Europe完全的