COPD ExacerbationNCT03772639
Shared Decision Making in Hospitalized AECOPD
A study testing Shared decision making in people with COPD Exacerbation, run by Universidad de Granada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Shared decision making
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria were COPD patients hospitalized due to acute exacerbation
Who cannot join
- 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.
About this study
Official title: Shared Decision Making and Patient Engagement Program During AECOPD Hospitalization
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
Read the 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.
- Conditions
- COPD Exacerbation
- Being tested
- Shared decision making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision makingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 9 days and after discharge 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study startOct 2016
- Primary completionNov 2016
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772639
- Sponsor's protocol ID
- DF0082UG
- Status last verified
- Feb 2020
- First submitted
- 5 Dec 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35514131
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making and Patient Engagement Program During AECOPD Hospitalization
- ClinicalTrials.gov ID
- NCT03772639
- Acronym / sponsor ID
- DF0082UG
- Conditions
- COPD Exacerbation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Shared decision makingThe 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. |
| Control Group | No intervention | –The control group received standard care and pharmacological care including systemic steroids, antibiotics, inhaled bronchodilators, and oxygen therapy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria were COPD patients hospitalized due to acute exacerbation
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared decision makingDecision-making processes focused on the knowledge of the disease for set up adjusted care management about their necessities and engaging in recommended health behaviors | Other | Experimental group |
Primary outcome
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).
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Derived from this study: PubMed 35514131Cross 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision making in people with COPD Exacerbation, run by Universidad de Granada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03772639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.