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Completed

NCT Number: NCT03470025

Improving Psychosocial Well-being in COPD Patients in Rehabilitation

Because of a lack of clinical trials, there is currently a paucity of evidence on the most effective strategies to identify and address psychological co-morbidity in COPD, or on targeting these interventions to specific patient groups. The relationship between physiological disease impairment and patient's disease experience is weak. Some patients have highly impaired Quality of life (QoL) despite relatively minor lung function impairment, and others have good QoL despite severe lung function impairment. It is likely that psychological and behavioral factors may be relevant; moreover the coping strategies used by patients and their relationship to individual psychological factors have been incompletely explored. Pulmonary Rehabilitation (PR) is part of integrated COPD patient management and its potential impact on QoL should be underlined: several studies have found that physical exercise has a beneficial effect on depression symptoms [GOLD, 2017].

Before initiating PR a comprehensive and careful assessment should be performed: treatment goals, specific healthcare needs, smoking status, nutritional health, self-management capacity, health educational, psychological health status and social circumstances, medical history and comorbidities, and exercise capabilities and limitations. Moreover, PR has beneficial effects on mood status and daily activities.

Sustaining Pulmonary Rehabilitation benefits and regular exercise over the long term is difficult without any maintenance strategy. The main aim of this study is to assess the Effect of the Psychological Intervention (PI) on Quality of life, psychological status and well-being, and the maintenance of Pulmonary Rehabilitation benefits, in COPD patients.

A PI based on psychoeducation and psychological and emotional support may be a key to improve Quality of life and to bring COPD patients to show a greater awareness of their health status.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele Pisana

Roma, I-00163, Italy

About this study

In this pilot study we will perform two different methodologies of the Psychological Intervention: a telephone-based Psychological Intervention and combined face to face & telephone-based Psychological Intervention, integrating the COPD rehabilitation.

The study will be carried out in a real life setting. An initial sample of 36 COPD patients satisfying the inclusion criteria and accepting the participation of the study will be enrolled at the PR Unit of the IRCCS "San Raffaele Pisana" Roma-Italy. The study enrollment period will be of maximum six months, the treatment period is of six months, and the interim treatment evaluation is of three months will be performed. Max study duration will be of 12 months.

The participants will be recruited prospectively from consecutively admitted patients to the inpatient PR Unit. Participants will be required to have the diagnosis of COPD according to the ATS' Guideline [Qaseem et al., 2011]. All participants will sign informed consent approved by the Institutional Ethic Committee.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of COPD
  • Mini-Mental State Examination (MMSE) ≥ 26
  • 6 Minute Walking Test ≥ 90 meters , at admission
  • Obtaining Written Informed Consent

Exclusion criteria

  • Comorbidity influencing respiratory ability and functionality
  • Delta 6 Minute Walking Distance < 60 meters, at time of admission

Treatment and study plan

Psychological Intervention

Other
  • F-TPI group will be followed for a period of six months with a telephone-based and a face to face psychological intervention, performed by a clinical psychotherapist .
  • TPI group will be followed for a period of six months with a TPI characterized by 10 telephone clinical interviews, performed by a clinical psychotherapist.
  • CTRL group with COPD SoC without PI will follow the standard follow-up program for COPD patients after PR.

Other names: Medical therapy

Primary outcomes

  1. Change in Health related Quality of Life evaluated by the St. George's Respiratory Questionnaire

    Time frame: day 0 to day 182

    the St. George's Respiratory Questionnaire score

  2. Change in Quality of Life evaluated by the Short Form Health Survey General and Mental Health

    Time frame: day 0 to day 182

    the Short Form Health Survey General and Mental Health score

  3. Change in the degree of enjoyment and satisfaction in areas of daily functioning, evaluated by the Quality Of Life Enjoyment And Satisfaction Questionnaire

    Time frame: day 0 to day 182

    the Quality Of Life Enjoyment And Satisfaction Questionnaire score

  4. Maintenance of Functional Exercise evaluated by the Six Minute Walking Test

    Time frame: day 0 to day 182

    the Six Minute Walking Test score

  5. Maintenance of Respiratory Capacity evaluated by the Borg scale

    Time frame: day 0 to day 182

    the Borg scale score

  6. Assessment of dyspnea in activities of daily living by the Medical Research Council scale

    Time frame: day 0 to day 21 (period of the Pulmonary Rehabilitation )

    the Medical Research Council score

  7. Assessment of Respiratory Capacity by the Maugeri Foundation Respiratory Failure Questionnaire

    Time frame: day 0 to day 21 (period of the Pulmonary Rehabilitation)

    the Maugeri Foundation Respiratory Failure score

  8. Assessment of disability by the Barthel Index

    Time frame: day 0 to day 21 (period of the Pulmonary Rehabilitation )

    Barthel Index score

Secondary outcomes

  1. Change in psychological status evaluated by the Symptom Check List (SCL-90)

    Time frame: day 0 to day 182

    the SCL-90 scores

  2. Assessment of the severity of depression by the Beck Depression Inventory II

    Time frame: day 0 to day 182

    the Beck Depression Inventory score

  3. Assessment of different types of anxiety, state anxiety and trait anxiety, by State-Trait Anxiety Inventory Form Y.

    Time frame: day 0 to day 182

    the State-Trait Anxiety Inventory scores

  4. Change in the use of the Coping Strategies evaluated by Brief-COPE

    Time frame: day 0 to day 182

    Brief-COPE

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Registry information

Official study title

Psychological Intervention to Improve the COPD Patients' Psychosocial Well-being

Acronym: IMPROVE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2018
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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