Quality of Life in Pulmonary Rehabilitation: A Social Identity Based Intervention
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Social Identity goal-based Intervention
Sponsored by
About this trial
This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring Pulmonary
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.
Sites / Locations
- Liverpool Heart & Chest Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Social Identity Goal-Based Intervention
Standard Care
Arm Description
Participants will receive collaborative goal-setting
Participants will receive usual standard treatment
Outcomes
Primary Outcome Measures
Change in Health-related Quality of Life (QoL) scores from baseline
QoL measured using Euroquol EQ-5D-3L and 5L questionnaires
Secondary Outcome Measures
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).
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
Full Information
NCT ID
NCT02288039
First Posted
October 31, 2014
Last Updated
March 7, 2017
Sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborators
Edge Hill University
1. Study Identification
Unique Protocol Identification Number
NCT02288039
Brief Title
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborators
Edge Hill University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Pulmonary
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Social Identity Goal-Based Intervention
Arm Type
Experimental
Arm Description
Participants will receive collaborative goal-setting
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Participants will receive usual standard treatment
Intervention Type
Other
Intervention Name(s)
Social Identity goal-based Intervention
Intervention Description
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 Outcome Measure Information:
Title
Change in Health-related Quality of Life (QoL) scores from baseline
Description
QoL measured using Euroquol EQ-5D-3L and 5L questionnaires
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in magnitude of social identification score measured using a standardised scale from baseline
Description
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
Title
Change in disease-specific quality of life (QoL) scores from baseline
Description
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
Other Pre-specified Outcome Measures:
Title
Change in anxiety and depression scores from baseline
Description
These will be determined using the Hospital and Anxiety and Depression Scale questionnaire
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Change in exercise adherence rates from baseline
Description
This is defined as the number of prescribed exercise sessions performed
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change in functional capacity score from baseline
Description
This is defined as total distance covered in a 6 minutes walk test.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Healthcare resources use
Description
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
Title
Cost-effectiveness
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bashir Matata, PhD
Organizational Affiliation
Liverpool Heart & Chest Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Liverpool Heart & Chest Hospital
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19200408
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.
Results Reference
background
PubMed Identifier
16238844
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.
Results Reference
background
PubMed Identifier
15601506
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.
Results Reference
background
PubMed Identifier
29423258
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.
Results Reference
derived
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Quality of Life in Pulmonary Rehabilitation: A Social Identity Based Intervention
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