An interventional study of Social Identity goal-based Intervention in Chronic Obstructive Pulmonary Disease, sponsored by Liverpool Heart and Chest Hospital NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-03-09.
Sponsored by Liverpool Heart and Chest Hospital NHS Foundation Trust · Not applicable, Interventional, and Other
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
Previous research indicates that self-management interventions vary, comprising of patient education, action planning, goal setting, cognitive behavioural therapy and motivational interviewing. The delivery of these interventions was largely conducted through individual sessions either face-to-face or telephone conversations, or through the individual distribution of booklet information. As such, research has heavily focused on individual-focused self-management interventions in order to facilitate QoL in COPD patients. It is not surprising that interventions have largely taken an individualistic approach given that sufferers of COPD are diagnosed and treated as individuals (e.g., in hospital, or when visiting the doctor). However, at times COPD management is delivered in groups (e.g., exercise/ education rehabilitation sessions). Indeed, the group-management of COPD treatment for improving the QoL of COPD patients has largely remained unexplored. Therefore, a significant limitation of self-management approaches used to-date concerns the lack of consideration given to group-management interventions. The proposed study therefore aims to address this limitation by investigating the a group-based psychological intervention.
Participants will be assigned to one of two groups: 1) the control group containing standard care; and 2) the intervention group containing standard care plus the intervention. Participants will attend weekly rehabilitation classes for 8 weeks, regardless of the rehabilitation group assigned. In addition, participants will complete a quality of life questionnaire that will ask questions about subjective feelings. The questionnaire will take about 20 minutes to complete. The questionnaire will be completed at the start of the 8-week rehabilitation programme, at the mid-point, and at the end of the rehabilitation programme.
In the intervention arm of the study participants will take part in three focus group discussions. The focus group discussions will be with members of the research team and the rest of your rehabilitation group. The first two sessions help participants plan strategies in order to get the most benefit from the rehabilitation programme. The third session will entail some reflection regarding how well participants thought the programme had addressed their rehabilitation needs. Finally, all participants will complete the quality of life questionnaire again at 3 months after completing the 8-week rehabilitation programme by return stamp-addressed envelope.
4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 84 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Liverpool Heart and Chest Hospital NHS Foundation Trust is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Participants will receive collaborative goal-setting
Other: Social Identity goal-based Intervention
Participants will receive usual standard treatment
Phase 1: collaborative group discussion in order to establish what group members want to achieve by the end of their 8-week pulmonary rehabilitation programme. Phase 2: further collaborative group discussion with the emphasis on evaluating, monitoring, and providing feedback on goal attainment. Phase 3: focus group interviews with an emphasis on reviewing the goal setting process that patients have engaged with.
Change in Health-related Quality of Life (QoL) scores from baseline
QoL measured using Euroquol EQ-5D-3L and 5L questionnaires
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
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).
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
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
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in anxiety and depression scores from baseline
These will be determined using the Hospital and Anxiety and Depression Scale questionnaire
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Change in exercise adherence rates from baseline
This is defined as the number of prescribed exercise sessions performed
Time frame: Baseline, 4 weeks, 8 weeks
Change in functional capacity score from baseline
This is defined as total distance covered in a 6 minutes walk test.
Time frame: Baseline, 4 weeks, 8 weeks
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.
Time frame: 12 weeks
Cost-effectiveness
and conduct a cost-effectiveness analysis. We will assess the incremental costs per QALY both from the NHS and societal perspectives.
Time frame: 12 weeks
Plan to share: No
Ran from Mar 2015 to primary completion in Sep 2016, 18 months.
Of 796 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 18 months is below that.
Counting every sponsor, half of 848 studies reached it within 24 months; a quarter within 11 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Liverpool Heart and Chest Hospital NHS Foundation Trust