Self-management training: a controlled investigation of its effectiveness in improving coping skills, mood and quality of life with patients with acquired physical disability

ISRCTN	ISRCTN16193155
DOI	https://doi.org/10.1186/ISRCTN16193155
Secondary identifying numbers	HRB_HSR/2010/12

Submission date: 10/02/2015
Registration date: 19/02/2015
Last edited: 20/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Deirdre Desmond
Scientific

Department of Psychology
Maynooth University
Maynooth
Co. Kildare
Ireland
Maynooth
Maynooth
Ireland

Phone	+353 017086479
Email	Deirdre.Desmond@nuim.ie

Study information

Study design	Single-centre controlled clinical trial (two group block randomized design)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Promoting quality of life and preventing secondary disability following acquired physical impairment: a controlled trial of a self-management intervention
Study objectives	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(s)	National Rehabilitation Hospital Ethics Committee, Maynooth University Ethics Committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/02/2011
Completion date	01/12/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	160
Key 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.
Key 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.
Date of first enrolment	01/08/2011
Date of final enrolment	31/07/2014

Locations

Countries of recruitment

Ireland

Study participating centre

National Rehabilitation Hospital

Ireland

Sponsor information

Maynooth University
University/education

Co.Kildare
Maynooth
Maynooth
Ireland

Website	https://www.maynoothuniversity.ie/research
"ROR"	https://ror.org/048nfjm95

Funders

Funder type

Government

Health Research Board (Ireland)

No information available

Results and Publications

Intention to publish date	31/12/2015
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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.
IPD sharing plan