Managing pain in HIV/AIDS: investigating the effectiveness of an education intervention for Malawian people living with HIV/AIDS and their family carers
| ISRCTN | ISRCTN72861423 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72861423 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/08/2012
- Registration date
- 09/10/2012
- Last edited
- 10/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Scientific
University of Nottingham
School of Nursing, Midwifery & Physiotherapy
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
| tony.arthur@nottingham.ac.uk |
Study information
| Study design | Two-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2012 |
| Completion date | 29/03/2013 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 179 patient/carer dyads |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2012 |
| Date of final enrolment | 29/03/2013 |
Locations
Countries of recruitment
- England
- Malawi
- United Kingdom
Study participating centre
NG7 2UH
United Kingdom
Sponsor information
University/education
c/o Paul Cartledge, Head of Contracts
Research and Graduate Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/07/2013 | Yes | No | |
| Results article | results | 01/07/2015 | Yes | No |
Editorial Notes
10/11/2016: Publication reference added.
