Clinical trial NCT02288039: Quality of Life in Pulmonary Rehabilitation: A Social Identity Based Intervention
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary
Lead sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Edge Hill University
First posted: 2014-11-11
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change in Health-related Quality of Life (QoL) scores from baseline
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Change in magnitude of social identification score measured using a standardised scale from baseline
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in disease-specific quality of life (QoL) scores from baseline
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
measure: Change in anxiety and depression scores from baseline
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change in exercise adherence rates from baseline
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change in functional capacity score from baseline
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Healthcare resources use
timeFrame: 12 weeks
measure: Cost-effectiveness
timeFrame: 12 weeks
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Heart & Chest Hospital
Study officials:
affiliation: Liverpool Heart & Chest Hospital
name: Bashir Matata, PhD
role: STUDY_DIRECTOR
References:
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. Epub 2009 Feb 5.
citation: 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. doi: 10.1348/014466605X37468.
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. doi: 10.1348/0144666042565380.
citation: Levy AR, Matata B, Pilsworth S, Mcgonigle A, Wigelsworth L, Jones L, Pott N, Bettany M, Midgley AW. An intervention for pulmonary rehabilitators to develop a social identity for patients attending exercise rehabilitation: a feasibility and pilot randomised control trial protocol. Pilot Feasibility Stud. 2018 Jan 27;4:40. doi: 10.1186/s40814-018-0238-z. eCollection 2018.