NCT02288039

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

October 31, 2014

Last Update Submit

March 7, 2017

Conditions

Keywords

Pulmonary

Outcome Measures

Primary Outcomes (1)

  • Change in Health-related Quality of Life (QoL) scores from baseline

    QoL measured using Euroquol EQ-5D-3L and 5L questionnaires

    Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (2)

  • 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

Other Outcomes (5)

  • Change in anxiety and depression scores from baseline

    Baseline, 4 weeks, 8 weeks, 12 weeks

  • Change in exercise adherence rates from baseline

    Baseline, 4 weeks, 8 weeks

  • Change in functional capacity score from baseline

    Baseline, 4 weeks, 8 weeks

  • +2 more other outcomes

Study Arms (2)

Social Identity Goal-Based Intervention

EXPERIMENTAL

Participants will receive collaborative goal-setting

Other: Social Identity goal-based Intervention

Standard Care

NO INTERVENTION

Participants will receive usual standard treatment

Interventions

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.

Social Identity Goal-Based Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients excluded from the study based on these criteria will be assigned to a rehabilitation group not involved in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool Heart & Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 19200408BACKGROUND
  • 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.

    PMID: 16238844BACKGROUND
  • 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.

    PMID: 15601506BACKGROUND
  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bashir Matata, PhD

    Liverpool Heart & Chest Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 11, 2014

Study Start

March 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations