Plain English Summary
Background and study aims:
The study aims to investigate the effects of an educational programme on managing pain among people living with HIV/AIDS. Pain is frequently experienced and difficult to manage in HIV infection, so we want to assess if providing people living with HIV/AIDS and their family carers with a short educational package will help the way pain is managed is effective. It is hoped that this will assist in reducing the pain experienced.
Who can participate?
The study aims to recruit 179 people with HIV/AIDS (stage III or IV) and their family carers. Both patient and carer need to be aged 18 years and above and write in English or Tumbuka.
What does the study involve?
The study involves randomly allocating patients with HIV/AIDS and their family carers into two groups. This allocation is determined by a computer (which has no information about participants). Initial assessments will be conducted before group allocation. In one group participants will receive health education via a face-to-face meeting with pain education nurse and a leaflet about pain assessment and management. The other group will receive usual care. After eight weeks a staff nurse will conduct follow-up assessments with participants using the same questionnaire used for initial assessments. Participants allocated to usual care will still receive the educational package about pain, but not until after they have completed the follow-up assessments.
What are the possible benefits and risks of participating?
There are no direct benefits for those taking part in the study. However this may be an opportunity for patients and family carers to learn ways of assessing the pain experienced and how to better manage that pain. There are no risks involved to those taking part in the study and every effort will be made not to inconvenience patients or their family carers.
Where is the study run from?
Ekwendeni Hospital (Malawi)
When is the study starting and how long is it expected to run for?
The study will start in October 2012 and participants will be followed-up for assessments after two months
Who is funding the study?
The University of Nottingham School of Nursing, Midwifery and Physiotherapy and the Malawi Government
Who is the main contact?
Dr Tony Arthur
tony.arthur@nottingham.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Antony Arthur
ORCID ID
Contact details
University of Nottingham
School of Nursing
Midwifery & Physiotherapy
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
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tony.arthur@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
An educational intervention to reduce pain and improve pain management for Malawian people living with HIV/AIDS and their family carers in Malawi: randomised controlled trial
Acronym
Study hypothesis
Compared with standard care:
1. Patients who receive the pain education intervention will show reduced pain, improved knowledge and skills in managing pain, improved quality of life
2. Carers who receive pain education intervention will show improved knowledge and skill in managing pain, improved quality of life and improved motivation in providing care
Ethics approval
1.The University of Nottingham Medical School Ethics Committee, 27/04/2012, ref: SNMP11042012
2.The National Health Sciences Research Committee in Malawi, 18/06/2012, ref: NHSRC 1023
Study design
Two-arm randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Pain in HIV/AIDS
Intervention
Usual care versus a structured leaflet based education intervention that includes:
1. 30 minutes face-to-face meeting with the patient and family carer
2. A leaflet designed for HIV/AIDS patients and their family carers
3. Follow-up telephone at two weeks
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Average pain intensity, measured by Brief pain inventory at baseline and two months after randomisation
Secondary outcome measures
PLWHA
1. Pain knowledge, measured by patient pain questionnaire at baseline and two months after intervention
2. Quality of life, measured by African palliative care outcome scale at baseline and two months after intervention
Family carers
1. Pain knowledge, measured by family pain questionnaire at baseline and two months after intervention
2. Quality of life, measured African palliative care outcome scale at baseline and two months after intervention
3. Motivation, measured by Picot caregiver rewards scale at baseline and two months after intervention
Overall trial start date
01/10/2012
Overall trial end date
29/03/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
People living with HIV/AIDS (PLWHA):
1. Diagnosis of HIV/AIDS
2. Stages III or IV of HIV/AIDS
Carers:
Living with the person infected with HIV/AIDS and be most involved in their care
PLWHA and carers:
1. Both PLWHA and their carers will be able to read and write in English or Tumbuka (this is the vernacular language used in the northern part of Malawi)
2. Aged 18 years and above
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
179 patient/carer dyads
Participant exclusion criteria
1. Unable to give informed consent
2. PLWHA will be excluded if they have any other health problems that may hinder communication
3. Carers of patients with conditions other than HIV/AIDS
Recruitment start date
01/10/2012
Recruitment end date
29/03/2013
Locations
Countries of recruitment
Malawi
Trial participating centre
University of Nottingham
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
c/o Paul Cartledge
Head of Contracts
Research and Graduate Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Nottingham (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Funder name
Malawi Government (Malawi)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23849502
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25666517
Publication citations
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Protocol
Nkhoma K, Seymour J, Arthur A, An educational intervention to reduce pain and improve pain management for Malawian people living with HIV/AIDS and their family carers: study protocol for a randomised controlled trial., Trials, 2013, 14, 216, doi: 10.1186/1745-6215-14-216.