Impact of Family-based Pulmonary Rehabilitation (PR) on Patients With Chronic Obstructive Pulmonary Disease (COPD) and Their Family Members

January 28, 2014 updated by: Alda Sofia Pires de Dias Marques, Aveiro University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Aveiro, Portugal, 3810-193
        • University of Aveiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family-based PR group
Behavioral: Family-based PR program
The 12-week Family-based PR program will consist of psychoeducation for patients and family members (once a week) and exercise training for patients (3 times a week). The psychoeducation component aims to empower the family with strategies to facilitate a functional and healthy adjustment to the disease and includes educational and psychosocial support components.
Active Comparator: Conventional PR group
Behavioral: Conventional PR program
The 12-week Conventional PR program will consist of psychoeducation (once a week) and exercise training (3 times a week) for patients only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before, immediately after, 3 and 6 months after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in psychosocial adjustment to the disease
Time Frame: Before, immediately after, 3 and 6 months after the intervention
Psychosocial adjustment to the disease will be measured using the Psychosocial Adjustment to Illness Scale-Self report (PAIS-SR), which is a 46-item scale with 7 domains. Two types of scores arise from the data: a score from each domain and a total PAIS-SR score, with higher scores indicating poorer adjustment.
Before, immediately after, 3 and 6 months after the intervention
Change in psychological well-being (depression, anxiety and stress)
Time Frame: Before, immediately after, 3 and 6 months after the intervention
Depression Anxiety Stress Scales are designed to measure the 3 related negative emotional states of depression, anxiety and stress. Higher scores indicate a worst psychological outcome.
Before, immediately after, 3 and 6 months after the intervention
Change in caregiving difficulties (for family members only)
Time Frame: Before, immediately after, 3 and 6 months after the intervention
Caregiving difficulties will be measured with the Carers Assessment of Difficulties Index (CADI), which comprises 7 sub-scales. Higher scores indicate greater subjective burden.
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)
Time Frame: Immediately after the intervention
Semi-structured focus group interviews will be conducted with patients and family members to explore the impact of the Family-based PR program.
Immediately after the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in activities limitation resulting from breathlessness
Time Frame: Before, immediately after, 3 and 6 months after the intervention
The Modified British Medical Research Council questionnaire comprises five grades (statements) in a scale from 0 to 4, with higher grades indicating greater perceived respiratory limitation.
Before, immediately after, 3 and 6 months after the intervention
Change in Body Mass Index
Time Frame: Before, immediately after, 3 and 6 months after the intervention
Before, immediately after, 3 and 6 months after the intervention
Change in exercise tolerance
Time Frame: Before, immediately after, 3 and 6 months after the intervention
Patients' exercise tolerance will be assessed with the 6-minute walk test. The maximal distance walked during 6 minutes and the associated respiratory symptoms will be collected.
Before, immediately after, 3 and 6 months after the intervention
Change in muscle strength (arm flexors and knee extensors)
Time Frame: Before, immediately after, 3 and 6 months after the intervention
Isotonic muscle strength will be assessed with the 10 repetition maximum (10-RM), which is the maximum amount of weight that can be moved through the full range of motion 10 times with the proper technique and without compensatory movements. Isometric muscle strength of the knee extensors will be assessed with a hand-held dynamometer.
Before, immediately after, 3 and 6 months after the intervention
Change in functional balance
Time Frame: Before, immediately after, 3 and 6 months after the intervention
Functional balance will be measured with the Timed Up-and-Go test. The time needed to perform the test will be recorded.
Before, immediately after, 3 and 6 months after the intervention
Change in health-related quality of life
Time Frame: Before, immediately after, 3 and 6 months after the intervention
The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure quality of life in patients with chronic lung disease. It has 3 domains: symptoms, activities and impact. Scores range from 0 to 100 and higher values indicate a poorer quality of life.
Before, immediately after, 3 and 6 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aveiro University

Collaborators

Fundação para a Ciência e a Tecnologia

Investigators

  • Study Chair: Daniela M. Figueiredo, PhD, School of Health Sciences of the University of Aveiro (ESSUA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

January 29, 2014

Last Update Submitted That Met QC Criteria

January 28, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPD/CIF/109502/2009
  • 13638 (Other Grant/Funding Number: Quadro de Referência Estratégico Nacional (QREN))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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