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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 6 July 2015
Main ID:  ISRCTN16193155
Date of registration: 19/02/2015
Prospective Registration: No
Primary sponsor: Maynooth University
Public title: Self-management training: a controlled investigation of its effectiveness in improving coping skills, mood and quality of life with patients with acquired physical disability
Scientific title: Promoting quality of life and preventing secondary disability following acquired physical impairment: a controlled trial of a self-management intervention
Date of first enrolment: 01/08/2011
Target sample size: 160
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN16193155
Study type:  Interventional
Study design:  Single-centre controlled clinical trial (two group block randomized design) (Prevention)  
Phase: 
Countries of recruitment
Ireland
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Deirdre    Desmond
Address:  Department of Psychology Maynooth University Maynooth Co. Kildare Ireland Maynooth Maynooth Ireland
Telephone: +353 017086479
Email: Deirdre.Desmond@nuim.ie
Affiliation: 
Key inclusion & exclusion criteria
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.
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.

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Patients with acquired physical impairment (spinal cord injury and limb amputation)
Mental and Behavioural Disorders
Intervention(s)
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'.
Primary Outcome(s)
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(s)
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.
Secondary ID(s)
HRB_HSR/2010/12
Source(s) of Monetary Support
Health Research Board (Ireland)
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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