- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT01848483
Living Well Project for Persons With AIDS
The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Georgia
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Atlanta, Georgia, Egyesült Államok, 30322
- Emory University, Nell Hodgson Woodruff School of Nursing
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Kísérleti: 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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Más nevek:
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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Egyéb: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Change in Quality of Life
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Clinical Indicator: Change in Mortality at 12 Months Post-baseline
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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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Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Marcia McDonnell Holstad, phD, Emory University
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- RNS vírusfertőzések
- Vírusos betegségek
- Fertőzések
- Vérrel terjedő fertőzések
- Fertőző betegségek
- Szexuális úton terjedő betegségek, vírusos
- Szexuális úton terjedő betegségek
- Lentivírus fertőzések
- Retroviridae fertőzések
- Immunrendszeri betegségek
- Lassú vírusos betegségek
- HIV fertőzések
- Szerzett immunhiányos szindróma
- Immunhiányos szindrómák
Egyéb vizsgálati azonosító számok
- IRB00059987
- NIH/NINR-1R01NR014054-01 (Egyéb azonosító: Other)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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