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

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ClinicalTrials.gov Identifier: NCT02288039
Recruitment Status : Completed
First Posted : November 11, 2014
Last Update Posted : March 9, 2017
Sponsor:
Collaborator:
Edge Hill University
Information provided by (Responsible Party):
Liverpool Heart and Chest Hospital NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Social Identity goal-based Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Actual Study Start Date : March 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Social Identity Goal-Based Intervention
Participants will receive collaborative goal-setting
Other: Social Identity goal-based Intervention
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.

No Intervention: Standard Care
Participants will receive usual standard treatment



Primary Outcome Measures :
  1. Change in Health-related Quality of Life (QoL) scores from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    QoL measured using Euroquol EQ-5D-3L and 5L questionnaires


Secondary Outcome Measures :
  1. Change in magnitude of social identification score measured using a standardised scale from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    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).

  2. Change in disease-specific quality of life (QoL) scores from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    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


Other Outcome Measures:
  1. Change in anxiety and depression scores from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    These will be determined using the Hospital and Anxiety and Depression Scale questionnaire

  2. Change in exercise adherence rates from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks ]
    This is defined as the number of prescribed exercise sessions performed

  3. Change in functional capacity score from baseline [ Time Frame: Baseline, 4 weeks, 8 weeks ]
    This is defined as total distance covered in a 6 minutes walk test.

  4. Healthcare resources use [ Time Frame: 12 weeks ]
    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.

  5. Cost-effectiveness [ Time Frame: 12 weeks ]
    and conduct a cost-effectiveness analysis. We will assess the incremental costs per QALY both from the NHS and societal perspectives.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288039


Locations
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United Kingdom
Liverpool Heart & Chest Hospital
Liverpool, United Kingdom, L14 3PE
Sponsors and Collaborators
Liverpool Heart and Chest Hospital NHS Foundation Trust
Edge Hill University
Investigators
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Study Director: Bashir Matata, PhD Liverpool Heart & Chest Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Liverpool Heart and Chest Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02288039    
Other Study ID Numbers: 1132
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Liverpool Heart and Chest Hospital NHS Foundation Trust:
Pulmonary
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases