Outcomes for Antiretroviral Therapy Patients Receiving Palliative Care (TOPCare)
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Purpose
Despite overwhelming need for effective HIV palliative care in sub-Saharan Africa, a systematic appraisal of the literature found almost no outcome or evaluative evidence.
Aim:
The investigators aim to evaluate the efficacy of HIV palliative care training and a simple palliative care assessment tool provided to nurses of patients on Antiretroviral Therapy (ART), and to evaluate this in terms of patient outcomes under clinical experimental conditions in 2 African countries using randomised controlled trial (RCT) designs.
Intervention being tested:
Within each well-established HIV ART clinic, patients will be randomly allocated to either continue receiving standard care (control group) or to receive standard care plus appointments with a clinic nurse trained in basic palliative care (intervention group).
Methods:
Design: Each Phase III clinical trial (i.e. one trial in each of 2 countries) will be powered and conducted in parallel to a common research design protocol, thus permitting evidence of outcomes that reflects 2 different ART providers, providing evidence of palliative care efficacy relevant to different HIV care settings.
Primary outcome: Each trial has been powered to a primary endpoint of pain control.
Secondary outcomes: The secondary outcomes are the core domains of palliative care as defined by the WHO (i.e. physical, including symptoms, psychological, social and spiritual) and measured by the APCA African POS. Further secondary outcomes measured will be: adherence to treatment; risk behaviours; health-related quality of life; psychological morbidity.
Inclusion: Patients will be screened and invited into the trial if they are on ART, score 3-5 on the 0-5 APCA African POS pain or symptom items, are 18 years or older, and can give informed consent to trial entry and data collection.
Analysis: An intention-to-treat analysis will be conducted to determine treatment response differences between the two conditions. In order to maximise the efficiency of longitudinal data, multi-level modelling will be applied as appropriate.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Other: Palliative care Other: Standard care |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Phase 3 Trial of Palliative Care for HIV Patients on Antiretroviral Therapy |
- Self-report pain using the APCA African POS [ Time Frame: Period of 4 months ]Our primary outcome is the pain item of the African Palliative Care Association Palliative care Outcome Scale
- Psychological morbidity [ Time Frame: Period of 4 months ]Psychological Morbidity using the GHQ
- Quality of Life [ Time Frame: 4 month period ]Quality of Life using the MOS-HIV
| Enrollment: | 240 |
| Study Start Date: | May 2011 |
| Study Completion Date: | August 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard care
Standard care will be provided to the control group, i.e. existing HIV outpatient multiprofessional care, ART monitoring and adherence support.
|
Other: Standard care
Patients attend monthly for their ART monitoring and prescription filling, and a multiprofessional team is available as necessary.
|
|
Experimental: Palliative care
Palliative care delivered by an existing nurse who has been provided with palliative care training, palliative care patient management planning records, and clinical supervision
|
Other: Palliative care
Regular appointments with an existing clinic nurse who has been trained in palliative care, the patient is asked about their physical, psychological, social and spiritual problems, and a care management plan devised with referral as necessary.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adult patients (18 years or older),
- with an HIV diagnosis known to the patient,
- currently on ART for at least one month, and
- scoring 3-5 (out of a range of 0-5) on pain or symptoms,
- with sufficient capacity to consent to trial entry.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01608802
| Kenya | |
| BOMU Hospital | |
| Mombasa, Kenya | |
| South Africa | |
| Ivan Toms Clinic | |
| Cape Town, Western Cape, South Africa | |
| Principal Investigator: | Richard Harding, PhD | King's College London |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr Richard Harding, Associate Professor of Palliative Care, King's College London |
| ClinicalTrials.gov Identifier: | NCT01608802 History of Changes |
| Other Study ID Numbers: |
6594/3200 |
| Study First Received: | May 28, 2012 |
| Last Updated: | June 9, 2014 |
Keywords provided by King's College London:
|
HIV Antiretroviral therapy Palliative care Pain |
ClinicalTrials.gov processed this record on May 22, 2017