Terminé

Rehabilitation for Elderly Patients With COPD and Their Families: Promoting a Comprehensive, Integrated Intervention Based on the International Classification of Functioning, Disability and Health (ICF)

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Ce qui est testé

Family-based PR program

+ Conventional PR program

Comportemental
Qui peut participer

Maladie chronique+5

+ Maladies pulmonaires obstructives

+ Maladies pulmonaires

À partir de 18 ans
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Soins de support

Interventionnel
Date de début : janvier 2012
Voir le détail du protocole

Résumé

Sponsor principalAveiro University
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 janvier 2012

Date à laquelle le premier participant a commencé l'étude.

Patients with COPD often need assistance from their significant others (family member) to cope with the impacts of the disease. Family members are, therefore, the primary source of support to patients and may be affected by patient's condition through role changes, impact on social activities, emotional stress and financial burden. Although the impact of COPD on family members is an emergent area of research, there are few interventions directed at supporting both patients and families. The World Health Organization has recognized the importance of changing the focus of the interventions for patients with chronic diseases and has recommended family integration in rehabilitation programs. In COPD, the inclusion of family members in PR programs, a core component of the management of patients with COPD, may contribute to promote a better adjustment of the whole family to the disease and, thus, improve their well-being. However, this has not been investigated yet. The purpose of this study is to explore the impacts of Family-based PR on patients with COPD and their family members. This study will enroll patients with COPD and family members who are identified as their primary caregiver. Recruitment will take place at primary care centers via general practitioners. A Family-based PR program will be designed according to a comprehensive literature review and the findings from a previous observational study exploring the expectations, needs and concerns of patients and family members about a Family-based PR program. Then, dyads (patient and respective family member) who agree to participate will be randomly assigned to either the Family-based PR group or the Conventional PR group. The former group will participate in a Family-based PR program consisting of exercise training for patients and psychoeducation for dyads. In the Conventional PR group, only patients will participate in the exercise sessions and psychoeducation. Both programs will last 12 weeks and will be implemented in primary care centers by physiotherapists and gerontologists. The impact of Family-based PR will be explored using a mixed-methods approach. Assessments will be conducted in both groups at 4 time points: before, immediately after, 3 and 6 months after the interventions. Patients and family members' adjustment to the disease, family coping behaviors and psychological well-being will be evaluated in these time points. In addition, patients' clinical status will be assessed with a wide range of outcomes, such as activities limitation resulting from breathlessness, exercise tolerance and health-related quality of life. Difficulties associated with the caregiving experience will be assessed in family members. Dyads participating in the Family-based PR program will also be invited to attend focus groups immediately after the intervention to assess their perspective about the intervention. Descriptive statistics will be used to characterise the sample. To analyse changes in outcome measures, data from the two groups will be compared at each time point. A sample size calculation using the primary outcome was performed based in a previous pilot study. It was found that statistically significant differences between groups would be detected with 21 dyads in each group. However, as PR programs usually have considerable dropouts (around 30%), 28 dyads will be recruited for each group.

Titre officielRehabilitation for Elderly Patients With COPD and Their Families: Promoting a Comprehensive, Integrated Intervention Based on the International Classification of Functioning, Disability and Health (ICF)
NCT02048306
Sponsor principalAveiro University
Dernière mise à jour : 27 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

56 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Soins de support

Cette étude teste des approches visant à améliorer le confort, le bien-être ou la qualité de vie des personnes atteintes d'une maladie, notamment en aidant à mieux gérer les symptômes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladie chroniqueMaladies pulmonaires obstructivesMaladies pulmonairesProcessus pathologiquesMaladies des voies respiratoiresConditions pathologiques, signes et symptômesAttributs de la maladieMaladie pulmonaire obstructive chronique (MPOC)

Critères

Inclusion criteria for patients: * clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria * ≥ 18 years old * clinically stable * able to provide their own informed consent Exclusion criteria for patients: * presence of severe psychiatric conditions * inability to understand and co-operate * exacerbations or hospital admissions one month prior to the intervention * presence of severe neurologic/ musculoskeletal conditions and/or unstable cardiovascular disease Inclusion criteria for family members: * caring for a relative with COPD on a regular basis * ≥ 18 years old * able to provide their own informed consent Exclusion criteria for family members: * presence of severe psychiatric conditions * inability to understand and co-operate

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental

Groupe II

Comparateur actif

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

University of Aveiro

Aveiro, PortugalOuvrir University of Aveiro dans Google Maps
Terminé1 Centres d'Étude