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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 56
- Locations
- 2
- Primary Endpoint
- Change in family coping behaviors
Study Overview
Brief Summary
The purpose of this study is to explore the impact of Family-based pulmonary rehabilitation (PR) on patients with chronic obstructive pulmonary disease (COPD) and their family members.
Dyads (patient and respective family member) will be randomly allocated to either a Family-based PR group or a Conventional PR group. PR programs will consist of exercise training and psychoeducation. In the Family-based PR program, both patients and family members will participate in psychoeducation sessions. In the Conventional PR group, only patients will be included. In both groups, exercise training sessions will be exclusively for patients.
It is expected that, by including patients with COPD and their family members in Family-based PR, they will become more competent and confident in the management of the disease, thus reducing the overall impact of COPD on patients and family members' well-being.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change in family coping behaviors
Time Frame: Before, immediately after, 3 and 6 months after the intervention
Family Crisis Oriented Personal Scales (F-COPES) include 5 sub-scales which identify family coping patterns. Higher scores indicate more positive coping and problem solving strategies.
Secondary Outcomes
- Change in psychosocial adjustment to the disease(Before, immediately after, 3 and 6 months after the intervention)
- Change in psychological well-being (depression, anxiety and stress)(Before, immediately after, 3 and 6 months after the intervention)
- Change in caregiving difficulties (for family members only)(Before, immediately after, 3 and 6 months after the intervention)
- Patients and family members' perspectives of the Family-based PR program (for Family-based PR group only)(Immediately after the intervention)
Investigators
Alda Sofia Pires de Dias Marques
Senior Lecturer
Aveiro University