Chronic Obstructive Pulmonary Disease (COPD)NCT02048306
Impact of Family-based Pulmonary Rehabilitation (PR) on Patients With Chronic Obstructive Pulmonary Disease (COPD) and Their Family Members
A study testing Family-based PR program and Conventional PR program in people with Chronic Obstructive Pulmonary Disease (COPD), run by Aveiro University at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Family-based PR program and Conventional PR program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- caring for a relative with COPD on a regular basis
- ≥ 18 years old
- able to provide their own informed consent
Who cannot join
- 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
- presence of severe psychiatric conditions
- inability to understand and co-operate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Family-based PR program, Conventional PR program
- Keywords
- Chronic obstructive pulmonary disease (COPD), Pulmonary rehabilitation, Family, Integrated care, Mixed methods
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based PR programBehavioural
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.
Conventional PR programBehavioural
The 12-week Conventional PR program will consist of psychoeducation (once a week) and exercise training (3 times a week) for patients only.
| Study group | Role | What they receive |
|---|---|---|
| Family-based PR group | Experimental | Not described Receives: Behavioral: Family-based PR program |
| Conventional PR group | Active comparator | Not described Receives: Behavioral: Conventional PR program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in family coping behaviors
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.
Measured: Before, immediately after, 3 and 6 months after the intervention
Secondary outcomes (4)
Change in psychosocial adjustment to the disease
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.
Measured: Before, immediately after, 3 and 6 months after the intervention
Change in psychological well-being (depression, anxiety and stress)
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.
Measured: Before, immediately after, 3 and 6 months after the intervention
Change in caregiving difficulties (for family members only)
Caregiving difficulties will be measured with the Carers Assessment of Difficulties Index (CADI), which comprises 7 sub-scales. Higher scores indicate greater subjective burden.
Measured: 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)
Semi-structured focus group interviews will be conducted with patients and family members to explore the impact of the Family-based PR program.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Alda Sofia Pires de Dias Marques, Aveiro University
- Investigators
- Alda S. Marques, PhD, Principal investigator, School of Health Sciences of the University of Aveiro (ESSUA)Daniela M. Figueiredo, PhD, Study chair, School of Health Sciences of the University of Aveiro (ESSUA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048306
- Sponsor's protocol ID
- RIPD/CIF/109502/2009
- Other IDs
- 13638
- Status last verified
- Jan 2014
- First submitted
- 24 Jan 2014
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23343360Jacome 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.
PubMed 23294436Figueiredo 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.
PubMed 23909830Figueiredo 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.
PubMed 24053489Marques 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.
PubMed 25340477
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02048306
- Acronym / sponsor ID
- RIPD/CIF/109502/2009
- Keywords
- Chronic obstructive pulmonary disease (COPD), Pulmonary rehabilitation, Family, Integrated care, Mixed methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-based PR group | Experimental | Behavioral: Family-based PR program |
| Conventional PR group | Active comparator | Behavioral: Conventional PR program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- caring for a relative with COPD on a regular basis
Key exclusion criteria (6 listed)
- 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
- presence of severe psychiatric conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-based PR programThe 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. | Behavioural | Family-based PR group |
| Conventional PR programThe 12-week Conventional PR program will consist of psychoeducation (once a week) and exercise training (3 times a week) for patients only. | Behavioural | Conventional PR group |
Primary outcome
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.
4 secondary outcomes
Change in psychosocial adjustment to the disease
Time frame: 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
Change in caregiving difficulties (for family members only)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- Background: PubMed 23343360Marques 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.
- Background: PubMed 23294436Jacome 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.
- Background: PubMed 23909830Figueiredo 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.
- Background: PubMed 24053489Figueiredo 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.
- Derived from this study: PubMed 25340477Marques 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alda S. Marques, PhD principal investigator
School of Health Sciences of the University of Aveiro (ESSUA)
Daniela M. Figueiredo, PhD study chair
School of Health Sciences of the University of Aveiro (ESSUA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based PR program and Conventional PR program in people with Chronic Obstructive Pulmonary Disease (COPD), run by Aveiro University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in family coping behaviors (time frame: Before, immediately after, 3 and 6 months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02048306, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.