Quality of Life in Pulmonary Rehabilitation: A Social Identity Based Intervention

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

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.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Social Identity goal-based Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social Identity Goal-Based Intervention<br>Participants will receive collaborative goal-setting | Other: Social Identity goal-based Intervention<br>* 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.<br>|
| No Intervention: Standard Care<br>Participants will receive usual standard treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary