Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Pilot Study to Assess the Feasibility and Efficacy of a Social Identity Theory Based Intervention to Improve the Quality of Life of Patients Attending Pulmonary Rehabilitation.
Verified date | March 2017 |
Source | Liverpool Heart and Chest Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main aim of pulmonary rehabilitation is to improve the quality of life of patients that have been diagnosed with chronic lung disease. The challenge for pulmonary rehabilitation is that many patients do not complete their agreed or prescribed training targets which may be related to the way pulmonary rehabilitation is delivered. There is a belief among doctors and other healthcare professionals delivering pulmonary rehabilitation care that patients who are working together as part of a group may better accomplish their agreed training targets (intervention). The intervention aims to encourage members of the group to interact and support each other during the rehabilitation sessions in order to attain agreed pulmonary rehabilitation goals
Status | Completed |
Enrollment | 84 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Inclusion criteria are that patients score between 1 and 4 on the Modified Medical Research Council Dyspnoea Scale and have not previously been enrolled on a pulmonary rehabilitation programme Exclusion Criteria: - Patients excluded from the study based on these criteria will be assigned to a rehabilitation group not involved in the study. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Liverpool Heart & Chest Hospital | Liverpool |
Lead Sponsor | Collaborator |
---|---|
Liverpool Heart and Chest Hospital NHS Foundation Trust | Edge Hill University |
United Kingdom,
Haslam SA, O'Brien A, Jetten J, Vormedal K, Penna S. Taking the strain: social identity, social support, and the experience of stress. Br J Soc Psychol. 2005 Sep;44(Pt 3):355-70. — View Citation
Iyer A, Jetten J, Tsivrikos D, Postmes T, Haslam SA. The more (and the more compatible) the merrier: multiple group memberships and identity compatibility as predictors of adjustment after life transitions. Br J Soc Psychol. 2009 Dec;48(Pt 4):707-33. doi: 10.1348/014466608X397628. — View Citation
Veenstra K, Haslam SA, Reynolds KJ. The psychology of casualization: evidence for the mediating roles of security, status and social identification. Br J Soc Psychol. 2004 Dec;43(Pt 4):499-514. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in anxiety and depression scores from baseline | These will be determined using the Hospital and Anxiety and Depression Scale questionnaire | Baseline, 4 weeks, 8 weeks, 12 weeks | |
Other | Change in exercise adherence rates from baseline | This is defined as the number of prescribed exercise sessions performed | Baseline, 4 weeks, 8 weeks | |
Other | Change in functional capacity score from baseline | This is defined as total distance covered in a 6 minutes walk test. | Baseline, 4 weeks, 8 weeks | |
Other | Healthcare resources use | We will assess the use of healthcare resources. We will specifically examine the issue of staff time in association with the delivery of the social identity intervention. | 12 weeks | |
Other | Cost-effectiveness | and conduct a cost-effectiveness analysis. We will assess the incremental costs per QALY both from the NHS and societal perspectives. | 12 weeks | |
Primary | Change in Health-related Quality of Life (QoL) scores from baseline | QoL measured using Euroquol EQ-5D-3L and 5L questionnaires | Baseline, 4 weeks, 8 weeks, 12 weeks | |
Secondary | Change in magnitude of social identification score measured using a standardised scale from baseline | The intervention fidelity will be assessed through determining whether social identification has been achieved. This will be measured with four items (from Doosje, Ellemers, & Spears, 1995; e.g. 'Do you see yourself as part of the [COPD exercise group]', 'Are you pleased to be part of the [COPD group]', 'Do you feel strong ties with others in the [COPD exercise group]?', 'Do you identify with others in the [COPD exercise group]. These scales are widely used and amended in this form and are generally found to provide a good index of the theoretical construct of social identification (e.g. see Haslam et al., 2004). | Baseline, 4 weeks, 8 weeks, 12 weeks | |
Secondary | Change in disease-specific quality of life (QoL) scores from baseline | This will be determined using the Chronic Respiratory Questionnaire and the St George's Respiratory Questionnaires. Additionally, the Survey Short Form (SF-36) will also be administered | Baseline, 4 weeks, 8 weeks, 12 weeks |
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