Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01884389
Status:
COMPLETED
Last Update Posted:
2018-01-29
First Post:
2013-06-14
Brief Title:
Randomized Trial of an HIV Navigation Program for Early Palliative Care
Sponsor:
Case Western Reserve University
Organization:
Case Western Reserve University
Study Overview
Official Title:
Randomized Trial of an HIV Navigation Program for Early Palliative Care
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is testing a navigation program for early palliative care provided in tandem with HIV primary care for persons living with HIV PLWH who are at high risk or mortality and morbidity related to their co-morbid chronic conditions Participants are enrolled for a period of 36 months with data collection at enrollment and every 9 months after for a total of 5 data collection time points Study participants enrolled will be randomized into one of two groups control or intervention Control group participants will receive control calls in between survey data collection time points Intervention group participants will participate in a Navigation Program which includes home visits and phone calls with an advanced practice nurse APN and licensed social worker LSW as well as visits calls by a volunteer if desired The frequency of visits calls will be determined based on level of need high medium or low
The specific aims of the study are to 1 identify needs and preferences for palliative care and advance care planning for PLWH in order to tailor an existing Navigation Program for this study 2 test the effectiveness of an HIV Navigation Program intervention on outcomes of quality of life symptom burden coping ability and advance care planning and 3 determine if effectiveness of the HIV Navigation Program intervention differs by age gender ethnicity education income level and level of palliative care service need
The specific aims of the study are to 1 identify needs and preferences for palliative care and advance care planning for PLWH in order to tailor an existing Navigation Program for this study 2 test the effectiveness of an HIV Navigation Program intervention on outcomes of quality of life symptom burden coping ability and advance care planning and 3 determine if effectiveness of the HIV Navigation Program intervention differs by age gender ethnicity education income level and level of palliative care service need
Detailed Description:
With the advent of effective antiretroviral treatment for HIV has come a marked increase in the number of persons living with HIVAIDS PLWHA with the highest prevalence since the epidemic began of more than 12 million While PLWHA survive longer they also experience increased burdens of chronic conditions related to lifestyle factors treatment side effects and age PLWHA are a population at great risk for high symptom burden impaired coping and social functioning decreased quality of life and inadequate end-of-life care The remarkable shift in attitudes towards HIV from an inevitably fatal disease to a chronic condition has been accompanied by a lessening emphasis on symptom management and end-of-life planning However while mortality from AIDS-defining conditions has decreased PLWHA continue to have unaddressed needs for coordinated care symptom management and proactive advance care planning Palliative care focused on comprehensive management of physical psychological social and spiritual needs of persons with incurable progressive illnesses is a health service uniquely designed to meet these needs This research project will test a model of early palliative care for PLWHA at high risk of mortality and morbidity First focus group methods will be used to explore views of PLWHA regarding their needs for symptom management and social support and attitudes towards advance care planning and end-of-life concerns We will then conduct a randomized trial of a novel HIV Navigation Program which will be a modification of an existing navigation program that uses trained and experienced volunteers as a core component offered by a large comprehensive hospice and palliative care organization The specific aims of this study are 1 to identify needs and preferences for palliative care and advance care planning of PLWHA in order to tailor an existing Patient Navigation Program to the specific needs of PLWHA with chronic conditions and 2 to test the effect of an HIV Patient Navigation Program intervention on outcomes of quality of life symptom burden coping ability and advance care planning and 3 to determine if effectiveness of the HIV Navigation Program intervention differs by age gender ethnicity education income level and level of palliative care service need Because of the increasing prevalence of HIV coexisting with chronic conditions there is an urgent need to assess palliative care needs and preferences of PLWHA and design effective interventions This interdisciplinary study will test at the community level a novel health service designed to meet the unique needs of chronically ill PLWHA and improve and support advance care planning Results from this study will increase understanding of who are PLWHA at highest risk for need of palliative services and provide a model for providing early palliative care support for PLWHA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NR014059 | NIH | None | httpsreporternihgovquickSearchR01NR014059 |