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OpenTrials
Completed

NCT Number: NCT03772639

Shared Decision Making in Hospitalized AECOPD

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

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Key information

Conditions

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Shared decision making

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Shared Decision Making and Patient Engagement Program During AECOPD Hospitalization

Important dates

Study start
2016
Primary completion
2016
Study completion
2019
First posted
Dec 11, 2018
Registry last updated
Feb 19, 2020

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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