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

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.

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

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

84

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Social Identity Goal-Based Intervention
Participants will receive collaborative goal-setting
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.
Ingen indgriben: Standard Care
Participants will receive usual standard treatment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Health-related Quality of Life (QoL) scores from baseline
Tidsramme: Baseline, 4 weeks, 8 weeks, 12 weeks
QoL measured using Euroquol EQ-5D-3L and 5L questionnaires
Baseline, 4 weeks, 8 weeks, 12 weeks

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in anxiety and depression scores from baseline
Tidsramme: Baseline, 4 weeks, 8 weeks, 12 weeks
These will be determined using the Hospital and Anxiety and Depression Scale questionnaire
Baseline, 4 weeks, 8 weeks, 12 weeks
Change in exercise adherence rates from baseline
Tidsramme: Baseline, 4 weeks, 8 weeks
This is defined as the number of prescribed exercise sessions performed
Baseline, 4 weeks, 8 weeks
Change in functional capacity score from baseline
Tidsramme: Baseline, 4 weeks, 8 weeks
This is defined as total distance covered in a 6 minutes walk test.
Baseline, 4 weeks, 8 weeks
Healthcare resources use
Tidsramme: 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.
12 weeks
Cost-effectiveness
Tidsramme: 12 weeks
and conduct a cost-effectiveness analysis. We will assess the incremental costs per QALY both from the NHS and societal perspectives.
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Studieleder: Bashir Matata, PhD, Liverpool Heart & Chest Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2015

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

31. oktober 2014

Først indsendt, der opfyldte QC-kriterier

10. november 2014

Først opslået (Skøn)

11. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. marts 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 1132

Plan for individuelle deltagerdata (IPD)

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