Skip to main content
Clinical Trials/NCT02288039
NCT02288039CompletedNot Applicable

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.

Liverpool Heart and Chest Hospital NHS Foundation Trust1 site in 1 country84 target enrollmentStarted: March 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
84
Locations
1
Primary Endpoint
Change in Health-related Quality of Life (QoL) scores from baseline

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Social Identity Goal-Based Intervention

Experimental

Participants will receive collaborative goal-setting

Intervention: Social Identity goal-based Intervention (Other)

Standard Care

No Intervention

Participants will receive usual standard treatment

Outcomes

Primary Outcomes

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

  • Change in magnitude of social identification score measured using a standardised scale from baseline(Baseline, 4 weeks, 8 weeks, 12 weeks)
  • Change in disease-specific quality of life (QoL) scores from baseline(Baseline, 4 weeks, 8 weeks, 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials