NCT04162392

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 good option to improve physical activity barriers in acute exacerbated COPD patients during the hospitalization period.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

November 11, 2019

Last Update Submit

November 13, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Health related quality of life: EQ-5D

    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

  • Functional capacity

    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.

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

  • Barriers to Being Active Quiz

    The Barriers to Being Active Quiz is a 21-item scale that provides a measure of 7 self-reported barriers to being physically active.This instrument uses a 4-point Likert scale for individuals to identify if they would say or think any of the statements would be true for them, with 0 being very unlikely to 3 being very likely. Per instrument instructions, each barrier has 3 items that are summed for scoring, with a range of 0 to 9 for each.

    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
Other: shared decision making

Control group

ACTIVE COMPARATOR
Other: control group

Interventions

Patients can choose the intervention that they want. There are different physiotherapy interventions were the patients have to do physical activity during the hospital stay. The physiotherapist explains the advantages and disadvantages of each treatment before they choose.

Experimental group

Patients receive a physiotherapy intervention but they do not have the opportunity to choose the treatment

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 14, 2019

Study Start

December 1, 2019

Primary Completion

April 1, 2020

Study Completion

August 1, 2020

Last Updated

November 14, 2019

Record last verified: 2019-11