Outcomes for Antiretroviral Therapy Patients Receiving Palliative Care (TOPCare)

This study is currently recruiting participants.
Verified May 2012 by King's College London
Sponsor:
Collaborators:
University College, London
University of Cape Town
Information provided by (Responsible Party):
Dr Richard Harding, King's College London
ClinicalTrials.gov Identifier:
NCT01608802
First received: May 28, 2012
Last updated: May 30, 2012
Last verified: May 2012
  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). The intervention nurse will receive weekly supervision from a local palliative care service and will use a simple assessment form at each patient appointment.

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. Each of the 2 HIV care facilities (one in each of Kenya and South Africa) is a highly experienced HIV and ART care provider, with proven longevity. The providers of the palliative care training are longstanding experts in the delivery of both palliative care training and palliative care.

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; and an additional measure of psychological morbidity.

The primary and secondary outcomes are the same for each country's trial.

This study aims to reject the null hypothesis that receipt of palliative care in addition to standard care does not affect pain compared to those receiving standard care alone.

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.

Outputs:

The investigators have selected an randomized controlled trial (RCT) design, with multiple country partners, in order that outputs have maximum potential influence.

The revised CONSORT trial statement for non-drug trials has been applied to ensure potential publication in the leading 400 medical journals.


Condition Intervention Phase
HIV
Other: Palliative care
Other: Standard care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by King's College London:

Primary Outcome Measures:
  • Self-report pain using the APCA African POS [ Time Frame: Period of 4 months ] [ Designated as safety issue: No ]
    Our primary outcome is the pain item of the African Palliative Care Association Palliative care Outcome Scale


Secondary Outcome Measures:
  • Psychological morbidity [ Time Frame: Period of 4 months ] [ Designated as safety issue: No ]
    Psychological Morbidity using the GHQ

  • Quality of Life [ Time Frame: 4 month period ] [ Designated as safety issue: No ]
    Quality of Life using the MOS-HIV


Estimated Enrollment: 240
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608802

Contacts
Contact: Richard Harding, PhD +442078485589 richard.harding@kcl.ac.uk
Contact: Lucy Bradley, BSc +4420784825518 lucy.bradley@kcl.ac.uk

Locations
Kenya
BOMU Hospital Active, not recruiting
Mombasa, Kenya
South Africa
Ivan Toms Clinic Recruiting
Cape Town, Western Cape, South Africa
Contact: Paul Nkurunziza         
Principal Investigator: Liz Gwyther, MSc         
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

Additional Information:
No publications provided by King's College London

Additional 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: May 30, 2012
Health Authority: UK: King's College London Research Ethics Committee

Keywords provided by King's College London:
HIV
Antiretroviral therapy
Palliative care
Pain

ClinicalTrials.gov processed this record on April 16, 2014