Plain English Summary
Background and study aims
People with acquired physical impairments, such as limb amputation and spinal cord injury,
commonly experience additional problems including pain, anxiety and depression. These problems can prevent them from participating fully in society and can diminish their quality of life (QoL). Traditionally, attempts to improve well-being for people with physical impairments have focused on treatment of these problems after they have become established. Opportunities for early intervention to manage pain and other problems before they become chronic are typically missed.
Self-management (SM) interventions have been developed in the context of patient-centred care, where patients are empowered to take a central role their health and well-being. SM interventions aim to provide patients with the necessary skills and confidence to deal with health-related problems and to manage negative emotions. SM has been used widely in chronic illnesses in which pain and disability are common. However, SM has not been used as a preventive intervention during the early rehabilitation phase following physical impairment.
The aim of our research is to investigate how well an SM programme works for the prevention of disabling secondary conditions and improvement of QoL following the onset of significant physical impairment. The key objective is to improve health and wellbeing. As the impact of acquired physical impairment extends beyond the individual patient to families and friends, improving health and quality of life for the patient will have positive spill over effects for families, friends and wider communities.
Who can participate?
Adults with limb amputation or spinal cord injury.
What does the study involve?
Participants are randomly allocated to one of two groups: receiving usual care plus the “Next Steps UK and Ireland self-management programme” or receiving usual care only.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
National Rehabilitation Hospital, Ireland
When is the study starting and how long is it expected to run for?
From February 2011 to July 2014.
Who is funding the study?
National Health Research Board (Ireland)
Who is the main contact?
Dr Deirdre Desmond
deirdre.desmond@nuim.ie
Trial website
Contact information
Type
Scientific
Primary contact
Dr Deirdre Desmond
ORCID ID
Contact details
Department of Psychology
Maynooth University
Maynooth
Co. Kildare
Ireland
Maynooth
Maynooth
Ireland
+353 017086479
Deirdre.Desmond@nuim.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HRB_HSR/2010/12
Study information
Scientific title
Promoting quality of life and preventing secondary disability following acquired physical impairment: a controlled trial of a self-management intervention
Acronym
Study hypothesis
1. Compared to standard treatment alone, individuals who receive the self-management intervention plus standard care will have lower levels of depressive and anxiety symptoms, and improved positive affect and positive mindset.
2. Compared to standard treatment alone, individuals who receive the self-management intervention will have higher levels of participation and health related quality of life.
3. Changes in both primary and secondary outcomes will correlate strongly with the intermediate outcome of self-efficacy.
Ethics approval
National Rehabilitation Hospital Ethics Committee, Maynooth University Ethics Committee
Study design
Single-centre controlled clinical trial (two group block randomized design)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Patients with acquired physical impairment (spinal cord injury and limb amputation)
Intervention
Participants were allocated to control or intervention groups according to timing of admission. Control group participants received usual care. Participants in the intervention group received usual care plus the 'Next Steps UK & Ireland self-management programme'.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Pain: Brief pain Inventory
2. Depressive Symptoms: Hospital Anxiety and Depression Scale
3. Positive Affect: Positive and Negative Affect Schedule Positive States of Mind scale
Data collected on admission to rehabilitation, 7 weeks later and at 6 months post-programme.
Secondary outcome measures
1. Restrictions in Activities and Participation: WHODAS-II and the Community Participation Indicators
2. Self-management knowledge, skills, confidence: Patient Activation Measure (SF)
3. Quality of Life: WHOQoL
Data collected on admission to rehabilitation, 7 weeks later and at 6 months post-programme.
Overall trial start date
01/02/2011
Overall trial end date
01/12/2015
Reason abandoned
Eligibility
Participant inclusion criteria
Inclusion criteria consist of (1) being aged 18 years or older; (2) having limb amputation or spinal cord injury; (3) English speaking; (4) no more than 3 weeks previous inpatient rehabilitation for the current condition; onset of index injury/condition within 1 year.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant exclusion criteria
Exclusion criteria: unable to provide informed consent; severe cognitive impairment; presence of any other serious health condition that attending physician believes limits their ability to participate in the study.
Recruitment start date
01/08/2011
Recruitment end date
31/07/2014
Locations
Countries of recruitment
Ireland
Trial participating centre
National Rehabilitation Hospital
Ireland
Sponsor information
Organisation
Maynooth University
Sponsor details
Co.Kildare
Maynooth
Maynooth
Ireland
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Research Board (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Primary outcome data will be presented at the International Society for Prosthetics and Orthotics World Congress in June 2015. We anticipate peer review publication by the end of 2015.
Intention to publish date
31/12/2015
Participant level data
Not expected to be available
Results - basic reporting
Publication summary