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Shared Decision Making in Hospitalized AECOPD

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ClinicalTrials.gov Identifier: NCT03772639
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

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

Condition or disease Intervention/treatment Phase
COPD Exacerbation Other: Shared decision making Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shared Decision Making and Patient Engagement Program During AECOPD Hospitalization
Actual Study Start Date : October 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: Experimental group
The experimental group received a standard medical and pharmacological care in a daily format and shared decision making (SDM). The general framework of SDM was developed focusing on self-management goals which include education that addresses continuous use of medication, behavioral change, breathing training, learning to interpret changes in the disease and its consequences, and use of medical and community resources.
Other: Shared decision making
Decision-making processes focused on the knowledge of the disease for set up adjusted care management about their necessities and engaging in recommended health behaviors

No Intervention: Control Group
The control group received standard care and pharmacological care including systemic steroids, antibiotics, inhaled bronchodilators, and oxygen therapy.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. COPD Knowledge [ 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 ]
    Chronic Obstructive Pulmonary Disease Questionnaire (COPD-Q). COPD knowledge was evaluated using the Chronic Obstructive Pulmonary Disease Knowledge Questionnaire (COPD-Q; Maples, Franks, Ray, Stevens, & Wallace, 2010). The COPD-Q is a valid, readable, and reliable 13-item (each one score 0 to 3) self-administered true/false questionnaire assessing COPD knowledge in patients with low health literacy skills. A higher punctuation indicates better results.

  2. Adherence of inhalers [ 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 ]
    The Test of Adherence to Inhalers (TAI) was used to assess the level of adherence to inhalers in asthma and COPD patients. The test has two subscores, first to identify non-adherent patients and to measure the non-adherence level, second was designed to guide clinically the treatment non-compliance patients. Low adherence is considered when scores are less than 45 points in the 10-items subscore.

  3. Functional capacity [ 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 ]
    Functional independence was assessed using the Functional Independence Mease Scale (FIM). This scale has 18 items that are grouped into 2 dimensions, 13 motor items, and 5 cognitive items. The total score range between 18 points (total dependence) to 126 points (Independence completes).

  4. Physical activity [ 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 ]
    The International Physical Activity Questionnaire (IPAQ) short form measures walking, moderate- and vigorous intensity, and total PA and daily time spent sitting on weekdays. PA was reported in MET·minutes/week and days per week and was scored using standardized IPAQ scoring protocols to yield total metabolic equivalent minutes (MET·minutes/week) of PA per week. Sitting time was reported as the amount of time in hours and/or minutes participants spent sitting on a weekday during the past seven days.

  5. Nutritional status [ 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 ]
    Nutritional status was assessed with Mini Nutritional Assessment (MNA). The MNA has a screening- and assessment part. The screening part consists of questions about food intake, weight loss, mobility, stress, neuropsychological problems and weight and height will be combined to report BMI in kg/m^2. When the MNA punctuation is ≥ 24 nutritional status can be considered good.

  6. Functional capacity associated with breathlessness [ 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 ]
    Functional capacity associated with breathlessness was assessed with London Chest Activity of Daily Living Scale (LCADL): The LCADL is a 15-item scale divided into 4 domains: self-care (4 items), domestic (6 items), physical (2 items), and leisure (3 items). The use of 0 representing 'I wouldn't do any way' and 5 representing that patients require help.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Marie Carmen Valenza, Principal Investigator, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03772639    
Other Study ID Numbers: DF0082UG
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No