Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial
Official title:
The Living Well Project: Early Palliative Care and Motivational Interviewing (MI) for Persons With AIDS
Verified date | December 2019 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall goal of this project is to implement and test the efficacy of an enhanced comprehensive multidisciplinary early palliative care (EPC) package that includes four motivational interviewing sessions (MI) for persons diagnosed with AIDS. We posit that the innovative EPC will improve quality of life, clinical and psychosocial outcomes and advance care planning in a cost effective manner and could promote engagement and retention in HIV care. If successful, it could serve as a model of early palliative care for persons with AIDS in the US.
Status | Completed |
Enrollment | 121 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory University, Nell Hodgson Woodruff School of Nursing | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Grady Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Quality of Life | 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. | Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline | |
Secondary | Clinical Indicator: Change in Mortality at 12 Months Post-baseline | Number of deaths at 12 months post baseline | Baseline, up to 12 months post- baseline | |
Secondary | Clinical Indicator: Change in Self-report Hospitalizations | 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. | Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline | |
Secondary | Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker | 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". | Baseline, 6 months post-baseline, and 12-months post baseline | |
Secondary | Change in Self-reported Completion of Advanced Care Planning Activities: Living Will | 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". | Baseline, 6 months post-baseline, and 12-months post baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01849393 -
Evaluating Rewards-Based Adherence and Electronic Medication Monitoring in HIV-Positive Adolescents
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N/A |