Condition category
Mental and Behavioural Disorders
Date applied
10/02/2015
Date assigned
19/02/2015
Last edited
20/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

https://www.maynoothuniversity.ie/research

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

Publication citations

Additional files

Editorial Notes