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Outcomes for Antiretroviral Therapy Patients Receiving Palliative Care (TOPCare)

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ClinicalTrials.gov Identifier: NCT01608802
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : June 10, 2014
Sponsor:
Collaborators:
University College, London
University of Cape Town
Information provided by (Responsible Party):
Dr Richard Harding, King's College London

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
HIV Other: Palliative care Other: Standard care Phase 2 Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase 3 Trial of Palliative Care for HIV Patients on Antiretroviral Therapy
Study Start Date : May 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Psychological morbidity [ Time Frame: Period of 4 months ]
    Psychological Morbidity using the GHQ

  2. Quality of Life [ Time Frame: 4 month period ]
    Quality of Life using the MOS-HIV


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608802


Locations
Kenya
BOMU Hospital
Mombasa, Kenya
South Africa
Ivan Toms Clinic
Cape Town, Western Cape, South Africa
Sponsors and Collaborators
King's College London
University College, London
University of Cape Town
Investigators
Principal Investigator: Richard Harding, PhD King's College London
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
TOPCare South African launch  This link exits the ClinicalTrials.gov site

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
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014

Keywords provided by Dr Richard Harding, King's College London:
HIV
Antiretroviral therapy
Palliative care
Pain