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Clinical Trials/NCT03772639
NCT03772639
Completed
Not Applicable

Shared Decision Making and Patient Engagement Program During AECOPD Hospitalization

Universidad de Granada0 sites42 target enrollmentOctober 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD Exacerbation
Sponsor
Universidad de Granada
Enrollment
42
Primary Endpoint
Health related quality of life
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Patients require good communication with the physician to improve control illness. Shared decision making is a promising opportunity for chronic disease management due to the relative cost, medicine optimization and decreases hospital admissions/re-admissions

Detailed Description

Chronic obstructive pulmonary disease (COPD) is the leading one on hospital care cost, physician services, and prescription drugs. Additionally to the disease progression with the reduction in lung function, COPD patients experiment a progressive decline in functional capacity and health-related quality of life (HRQoL) with a significant burden in terms of disability. Shared Decision Making is defined as an approach where clinicians and patients share the available information to making clinical decisions, and where patients are counseled. SDM is a way to empower patients when decisions are made about treatment as a determinant factor in patient-centered care. Decision aids have been proven effective in improving disease knowledge, decision making, and self-care.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
January 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marie Carmen Valenza

Principal Investigator

Universidad de Granada

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria were COPD patients hospitalized due to acute exacerbation

Exclusion Criteria

  • Exclusion criteria were the inability to provide informed consent, the presence of psychiatric or cognitive disorders, progressive neurological disorders, organ failure, cancer, or inability to cooperate. Patients who had experienced another exacerbation of COPD in the previous month were also excluded.

Outcomes

Primary Outcomes

Health related quality of life

Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up

European Quality of Life questionnaire consists of the EQ-5D visual analog scale and the EQ-5D index. The visual analog scale has a rating scale of 0-100 (0 worst possible health, and 100 best possible health). The questionnaire has 5 domains: mobility, self-care, usual activity, pain, and anxiety-depression. For each item, the subject selects one of 3 descriptive health states (from good to poor).

Secondary Outcomes

  • Physical activity(Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up)
  • Nutritional status(Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up)
  • Functional capacity associated with breathlessness(Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up)
  • COPD Knowledge(Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up)
  • Adherence of inhalers(Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up)
  • Functional capacity(Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up)

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