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Completed

NCT Number: NCT02288039

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

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool Heart & Chest Hospital

Liverpool, L14 3PE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Social Identity goal-based Intervention

Other

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Other

Collaborators

  • Edge Hill University

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2014
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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