Shared Decision Making in Hospitalized AECOPD

NCT03772639 | Completed

• 1 other identifier: DF0082UG
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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

Conditions

COPD Exacerbation

Outcome Measures

Primary Outcomes (1)

• Health related quality of life

  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).

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

Secondary Outcomes (6)

• 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

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

The control group received standard care and pharmacological care including systemic steroids, antibiotics, inhaled bronchodilators, and oxygen therapy.

Interventions

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidad de Granada: lead

Related Publications (1)

• Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.

  PMID: 35514131 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 11, 2018
• Study Start: October 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: January 1, 2019
• Last Updated: February 19, 2020

Record last verified: 2020-02