Clinical trial NCT02048306: Impact of Family-based Pulmonary Rehabilitation (PR) on Patients With Chronic Obstructive Pulmonary Disease (COPD) and Their Family Members
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease (COPD)
Pulmonary rehabilitation
Family
Integrated care
Mixed methods
Lead sponsor: Aveiro University
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2014-01-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in family coping behaviors
timeFrame: Before, immediately after, 3 and 6 months after the intervention
Secondary outcomes:
measure: Change in psychosocial adjustment to the disease
timeFrame: Before, immediately after, 3 and 6 months after the intervention
measure: Change in psychological well-being (depression, anxiety and stress)
timeFrame: Before, immediately after, 3 and 6 months after the intervention
measure: Change in caregiving difficulties (for family members only)
timeFrame: Before, immediately after, 3 and 6 months after the intervention
measure: Patients and family members' perspectives of the Family-based PR program (for Family-based PR group only)
timeFrame: Immediately after the intervention
Other outcomes:
measure: Change in activities limitation resulting from breathlessness
timeFrame: Before, immediately after, 3 and 6 months after the intervention
measure: Change in Body Mass Index
timeFrame: Before, immediately after, 3 and 6 months after the intervention
measure: Change in exercise tolerance
timeFrame: Before, immediately after, 3 and 6 months after the intervention
measure: Change in muscle strength (arm flexors and knee extensors)
timeFrame: Before, immediately after, 3 and 6 months after the intervention
measure: Change in functional balance
timeFrame: Before, immediately after, 3 and 6 months after the intervention
measure: Change in health-related quality of life
timeFrame: Before, immediately after, 3 and 6 months after the intervention
Locations:
city: Aveiro
country: Portugal
facility: University of Aveiro
Study officials:
affiliation: School of Health Sciences of the University of Aveiro (ESSUA)
name: Alda S. Marques, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Health Sciences of the University of Aveiro (ESSUA)
name: Daniela M. Figueiredo, PhD
role: STUDY_CHAIR
References:
citation: Marques A, Jacome C, Gabriel R, Figueiredo D. Comprehensive ICF core set for obstructive pulmonary diseases: validation of the activities and participation component through the patient's perspective. Disabil Rehabil. 2013 Sep;35(20):1686-91. doi: 10.3109/09638288.2012.750691. Epub 2013 Jan 24.
citation: Jacome C, Marques A, Gabriel R, Figueiredo D. Chronic obstructive pulmonary disease and functioning: implications for rehabilitation based on the ICF framework. Disabil Rehabil. 2013 Aug;35(18):1534-45. doi: 10.3109/09638288.2012.745625. Epub 2013 Jan 7.
citation: Figueiredo D, Gabriel R, Jacome C, Marques A. Caring for people with early and advanced chronic obstructive pulmonary disease: how do family carers cope? J Clin Nurs. 2014 Jan;23(1-2):211-20. doi: 10.1111/jocn.12363. Epub 2013 Aug 2.
citation: Figueiredo D, Gabriel R, Jacome C, Cruz J, Marques A. Caring for relatives with chronic obstructive pulmonary disease: how does the disease severity impact on family carers? Aging Ment Health. 2014;18(3):385-93. doi: 10.1080/13607863.2013.837146. Epub 2013 Sep 20.
citation: Marques A, Jacome C, Cruz J, Gabriel R, Brooks D, Figueiredo D. Family-based psychosocial support and education as part of pulmonary rehabilitation in COPD: a randomized controlled trial. Chest. 2015 Mar;147(3):662-672. doi: 10.1378/chest.14-1488.