NCT02048306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

1.9 years

First QC Date

January 24, 2014

Last Update Submit

January 28, 2014

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic obstructive pulmonary disease (COPD)Pulmonary rehabilitationFamilyIntegrated careMixed methods

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before, immediately after, 3 and 6 months after the intervention

Secondary Outcomes (4)

  • 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

Other Outcomes (6)

  • Change in activities limitation resulting from breathlessness

    Before, immediately after, 3 and 6 months after the intervention

  • Change in Body Mass Index

    Before, immediately after, 3 and 6 months after the intervention

  • Change in exercise tolerance

    Before, immediately after, 3 and 6 months after the intervention

  • +3 more other outcomes

Study Arms (2)

Family-based PR group

EXPERIMENTAL
Behavioral: Family-based PR program

Conventional PR group

ACTIVE COMPARATOR
Behavioral: Conventional PR program

Interventions

Family-based PR programBEHAVIORAL

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.

Family-based PR group
Conventional PR programBEHAVIORAL

The 12-week Conventional PR program will consist of psychoeducation (once a week) and exercise training (3 times a week) for patients only.

Conventional PR group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • caring for a relative with COPD on a regular basis
  • ≥ 18 years old
  • able to provide their own informed consent
  • presence of severe psychiatric conditions
  • inability to understand and co-operate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aveiro

Aveiro, Aveiro District, 3810-193, Portugal

Location

Related Publications (5)

  • 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.

    PMID: 23343360BACKGROUND

  • 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.

    PMID: 23294436BACKGROUND

  • 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.

    PMID: 23909830BACKGROUND

  • 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.

    PMID: 24053489BACKGROUND

  • 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.

    PMID: 25340477DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alda S. Marques, PhD

    School of Health Sciences of the University of Aveiro (ESSUA)

    PRINCIPAL INVESTIGATOR

  • Daniela M. Figueiredo, PhD

    School of Health Sciences of the University of Aveiro (ESSUA)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 29, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 29, 2014

Record last verified: 2014-01

Locations

PT(1)