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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Liverpool, Reino Unido, L14 3PE
- Liverpool Heart & Chest Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Sin intervención: Standard Care
Participants will receive usual standard treatment
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Health-related Quality of Life (QoL) scores from baseline
Periodo de tiempo: Baseline, 4 weeks, 8 weeks, 12 weeks
|
QoL measured using Euroquol EQ-5D-3L and 5L questionnaires
|
Baseline, 4 weeks, 8 weeks, 12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in magnitude of social identification score measured using a standardised scale from baseline
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in anxiety and depression scores from baseline
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Director de estudio: Bashir Matata, PhD, Liverpool Heart & Chest Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1132
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .