Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
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)
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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