Patient EmpowermentNCT04249518
Video Extradition of Continuous Positive Airway Pressure - Influence on Compliance
A study testing Videoeducation in people with Patient Empowerment and Patient Engagement, run by University of Aarhus.
Trial summary
Confirming or denying it in the future is an opportunity for certain patient groups to have the option of video delivery. So that in calm circumstances and possibly. several times can review the video and equipment in the home and hopefully achieve the same or better compliance with the ongoing treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Patient Empowerment, Patient Engagement, Patient Compliance
- What is being tested?
- Videoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,234 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2020to 15 Feb 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- candidate to CPAP
- over age of 18
Who cannot join
- Language issues
- sight or hearing handicap
- kognitive issues
- if drivers license is confiscated
Trial locations and contacts
No sites are listed yet.
About this study
Confirming or denying it in the future is an opportunity for certain patient groups to have the option of video delivery. So that in calm circumstances and possibly. several times can review the video and equipment in the home and hopefully achieve the same or better compliance with the ongoing treatment.
Read the detailed description
Due to increasing age, BMI and increased focus on obstructive sleep apnea syndrome (OSAS) in the background population, an increasing number of obstructive sleep apnea (OSA) patients are expected to occur in the coming years. This is accompanied by a need for multiple deliveries of CPAP equipment, which is the recommended treatment. A large proportion of patients are young and healthy with their OSA. There is an increased focus on telemedicine and much of the control of patients has been transferred to ambuflex, where treatment effect or treatment problems can be more easily detected. Socioeconomically, the deliveries, together with the medical examination, are resource-intensive and they also take up a lot of the patient's time and often at distant times. The quality of disclosure and information varies greatly in both time and amount of information. The large amount of information can be difficult to remember for patients and relatives. Most investigations require more visits to the hospital and therefore potentially provide several days away from work.
A similar trial has never been made, but randomized studies have been made in the past where the delivery of CPAP or low compliance patients has been supported by a motivational video or teaching with good effect. Studies have also been conducted that have attempted to identify CPAP dropout and compliance based on gender, age, educational level and personality, with unemployment being the only contributing prognostic factor in the negative direction. It is well-studied that if patients suffer from insomnia, the onset of CPAP can be difficult and this patient group should be monitored more closely and possibly. have additional help for startup.
The video in this study provides a brief review of illness and treatment, instruction on assembling and adapting equipment, and answers to the most frequently asked questions. Both groups are given the same telephone numbers as usual, for questions and here it will be included in the study if there is a difference in the amount of contacts to the ambulatory. The video has been tested in the relevant setting before starting the project. M Gaglianos made in 1988 is a literature review showing that video teaching is good and more effective than traditional teaching methods, with effects on short-term but not long-term memory.
- Conditions
- Patient Empowerment, Patient Engagement, Patient Compliance
- Being tested
- Videoeducation
- Medical subject headings
- Patient Participation, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoeducationBehavioural
No drugs used. The only difference in the to arms is the way the extradition is.
| Study group | Role | What they receive |
|---|---|---|
| nurse instruction of CPAP | No intervention | Normal extradition. 45 minutes face to face with a nurse. |
| Video extradition | Experimental | Access to 7 min video - explaining how to start CPAP and how to adjust the mask. Receives: Behavioral: Videoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance in percentage
Compliance at one month follow up. Minimum 0 % maximum 100 % compliance.
Measured: one month.
Secondary outcomes (3)
Depression
Depression measured by major depression index (MDI) questionnaire.MDI total score < 20 being normal and not depressed. MDI total score > 29 indicating severe depression.
Measured: one month.
Influencer
Education level registered by ISCED 2011 levels of education. Level 0-8. 8 being doctoral or equivalent. 0 being Early childhood Education (01 Early childhood educational development)
Measured: one month.
Insomnia
Insomnia measured by insomnia severity index (questionnaire). 0-12 points. 0 being no problems facing a sleep. 12 having lots og trouble falling a sleep.
Measured: One month .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start15 May 2020 (estimated)
- Primary completion15 Feb 2022 (estimated)
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EmpowermentStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 1,234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesper Bille, MD, Principal investigator, University Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249518
- Sponsor's protocol ID
- 15022020
- Status last verified
- Oct 2019
- First submitted
- 17 Jan 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Extradition of Continuous Positive Airway Pressure - Influence on Compliance
- ClinicalTrials.gov ID
- NCT04249518
- Acronym / sponsor ID
- 15022020
- Conditions
- Patient Empowerment, Patient Engagement, Patient Compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,234 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 15 May 2020 (estimated)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 31 Jan 2020 (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.
Confirming or denying it in the future is an opportunity for certain patient groups to have the option of video delivery. So that in calm circumstances and possibly. several times can review the video and equipment in the home and hopefully achieve the same or better compliance with the ongoing treatment.
Detailed description
Due to increasing age, BMI and increased focus on obstructive sleep apnea syndrome (OSAS) in the background population, an increasing number of obstructive sleep apnea (OSA) patients are expected to occur in the coming years. This is accompanied by a need for multiple deliveries of CPAP equipment, which is the recommended treatment. A large proportion of patients are young and healthy with their OSA. There is an increased focus on telemedicine and much of the control of patients has been transferred to ambuflex, where treatment effect or treatment problems can be more easily detected. Socioeconomically, the deliveries, together with the medical examination, are resource-intensive and they also take up a lot of the patient's time and often at distant times. The quality of disclosure and information varies greatly in both time and amount of information. The large amount of information can be difficult to remember for patients and relatives. Most investigations require more visits to the hospital and therefore potentially provide several days away from work.
A similar trial has never been made, but randomized studies have been made in the past where the delivery of CPAP or low compliance patients has been supported by a motivational video or teaching with good effect. Studies have also been conducted that have attempted to identify CPAP dropout and compliance based on gender, age, educational level and personality, with unemployment being the only contributing prognostic factor in the negative direction. It is well-studied that if patients suffer from insomnia, the onset of CPAP can be difficult and this patient group should be monitored more closely and possibly. have additional help for startup.
The video in this study provides a brief review of illness and treatment, instruction on assembling and adapting equipment, and answers to the most frequently asked questions. Both groups are given the same telephone numbers as usual, for questions and here it will be included in the study if there is a difference in the amount of contacts to the ambulatory. The video has been tested in the relevant setting before starting the project. M Gaglianos made in 1988 is a literature review showing that video teaching is good and more effective than traditional teaching methods, with effects on short-term but not long-term memory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| nurse instruction of CPAP | No intervention | –Normal extradition. 45 minutes face to face with a nurse. |
| Video extradition | Experimental | Behavioral: VideoeducationAccess to 7 min video - explaining how to start CPAP and how to adjust the mask. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- candidate to CPAP
- over age of 18
Key exclusion criteria (4 listed)
- Language issues
- sight or hearing handicap
- kognitive issues
- if drivers license is confiscated
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 |
|---|---|---|
| VideoeducationNo drugs used. The only difference in the to arms is the way the extradition is. | Behavioural | Video extradition |
Primary outcome
compliance in percentage
Time frame: one month.
Compliance at one month follow up. Minimum 0 % maximum 100 % compliance.
3 secondary outcomes
Depression
Time frame: one month.
Influencer
Time frame: one month.
Insomnia
Time frame: One month .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Jesper Bille, MD principal investigator
University Aarhus
Questions about this trial
What is this clinical trial studying?
A study testing Videoeducation in people with Patient Empowerment and Patient Engagement, run by University of Aarhus.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesper Bille, MD (0045+61651750, doctor.bille@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compliance in percentage (time frame: one month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2020.