EpilepsyNCT02673580
Tele-patient-reported Outcomes (telePRO) in Clinical Practice
A study testing Open Access telePRO and Standard telePRO in people with Epilepsy, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of this study is to compare quality of care and patient experiences in two outpatients follow-up activities: 1) Standard telePRO (fixed interval telePRO follow-up) and 2) Open Access telePRO (patient-initiated telePRO follow-up) Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Open Access telePRO and Standard telePRO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 593 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Jan 2018
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females from Age 15 years
- Diagnosis of epilepsy
- Referred to standard telePRO by a clinician
- Access to internet (web-responders in standard telePRO)
- Can speak and understand Danish
Who cannot join
- Paper responders
- Referred to telePRO proxy questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tele-patient-reported Outcomes (telePRO) in Clinical Practice - Effect of Patient-initiated Versus Fixed Interval telePRO Based Outpatient Follow-up
The aim of this study is to compare quality of care and patient experiences in two outpatients follow-up activities: 1) Standard telePRO (fixed interval telePRO follow-up) and 2) Open Access telePRO (patient-initiated telePRO follow-up)
Read the detailed description
The traditional system of routine outpatient follow-up of chronic disease in secondary care may involve a waste of resources if patients are well. The use of patient-reported outcomes (PRO) could support more flexible, cost-saving follow-up activities. AmbuFlex is a PRO system used in outpatient follow-up in the Central Denmark Region. PRO questionnaires are sent to patients at fixed intervals. The clinicians use the PRO data to decide whether a patient needs a visit or not (standard telePRO). PRO may make patients become more involved in their own care pathway, which may improve their self-management. Better self-management may also be achieved by letting patients initiate contact. The aim of this study is to obtain data on the effects of patient-initiated follow-up (open access telePRO) on resource utilisation, quality of care, and the patient perspective.
- Conditions
- Epilepsy
- Being tested
- Open Access telePRO, Standard telePRO
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Access telePROOther
In open access, contacts to the outpatient clinic are initiated solely by the patient. Contacts may be in the form of a PRO assessment like in standard telePRO, but at a time decided by the patient via the Danish National Health website "Sundhed.dk".
Standard telePROOther
Standard care: fixed interval telePRO follow-up. Patients receive a questionnaire with individually pre-specified intervals.
| Study group | Role | What they receive |
|---|---|---|
| Open Access telePRO | Other | Intervention: In open access, contact to the outpatient clinic is initiated by the patient by filling in a PRO questionnaire. Receives: Other: Open Access telePRO |
| Standard telePRO | Other | No intervention: In standard telePRO, outpatient follow-up activity is determined by a clinician and patients receive a questionnaire at fixed intervals. Receives: Other: Standard telePRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of contacts
Number of contacts includes all contacts with the outpatient clinic in the study follow-up period
Measured: 18 months
Secondary outcomes (10)
General health will be assessed by items from the SF-36 questionnaire
General health will be measured at baseline and after 18 months.
Measured: 18 months
Well-being wil be assessed by the WHO-5 Well-being Index
Well-being will be measured at baseline and after 18 months.
Measured: 18 months
Mortality
Mortality will be measured after 18 months.
Measured: 18 months
Number of seizures
Difference number of seizures (start - end) and will be measured at baseline and after 18 months.
Measured: 18 months
Side effects
Side effects will be measured at baseline and after 18 months.
Measured: 18 months
Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 4, 6, and 9)
Health literacy will be measured at baseline and after 18 months.
Measured: 18 months
Self-efficacy will be assessed by The General Self-Efficacy Scale
Self-efficacy will be measured at baseline and after 18 months.
Measured: 18 months
Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Confidence will be measured at baseline and after 18 months.
Measured: 18 months
Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Safety will be measured at baseline and after 18 months.
Measured: 18 months
Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Satisfaction will be measured at baseline and after 18 months.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 593 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region, TrygFonden, Denmark
- Responsible party
- Sponsor
- Investigators
- Niels Henrik Hjollund, Professor, Study director, Regional Hospital West Jutland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673580
- Sponsor's protocol ID
- TELEPRO
- Status last verified
- Jan 2017
- First submitted
- 28 Jan 2016
- Last updated
- 21 May 2018
- Results posted
- No
- Individual data sharing
- No
Publications
Schougaard LMV, Mejdahl CT, Christensen J, Lomborg K, Maindal HT, de Thurah A, Hjollund NH. Patient-initiated versus fixed-interval patient-reported outcome-based follow-up in outpatients with epilepsy: a pragmatic randomized controlled trial. J Patient Rep Outcomes. 2019 Sep 13;3(1):61. doi: 10.1186/s41687-019-0151-0.
PubMed 31520247Schougaard LM, Mejdahl CT, Petersen KH, Jessen A, de Thurah A, Sidenius P, Lomborg K, Hjollund NH. Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study. BMC Health Serv Res. 2017 Jan 26;17(1):83. doi: 10.1186/s12913-017-2015-8.
PubMed 28122609
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-patient-reported Outcomes (telePRO) in Clinical Practice - Effect of Patient-initiated Versus Fixed Interval telePRO Based Outpatient Follow-up
- ClinicalTrials.gov ID
- NCT02673580
- Acronym / sponsor ID
- TELEPRO
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 593 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Central Denmark Region, TrygFonden, Denmark
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 4 Feb 2016 (estimated)
- 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.
The aim of this study is to compare quality of care and patient experiences in two outpatients follow-up activities: 1) Standard telePRO (fixed interval telePRO follow-up) and 2) Open Access telePRO (patient-initiated telePRO follow-up)
Detailed description
The traditional system of routine outpatient follow-up of chronic disease in secondary care may involve a waste of resources if patients are well. The use of patient-reported outcomes (PRO) could support more flexible, cost-saving follow-up activities. AmbuFlex is a PRO system used in outpatient follow-up in the Central Denmark Region. PRO questionnaires are sent to patients at fixed intervals. The clinicians use the PRO data to decide whether a patient needs a visit or not (standard telePRO). PRO may make patients become more involved in their own care pathway, which may improve their self-management. Better self-management may also be achieved by letting patients initiate contact. The aim of this study is to obtain data on the effects of patient-initiated follow-up (open access telePRO) on resource utilisation, quality of care, and the patient perspective.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Access telePRO | Other | Other: Open Access telePROIntervention: In open access, contact to the outpatient clinic is initiated by the patient by filling in a PRO questionnaire. |
| Standard telePRO | Other | Other: Standard telePRONo intervention: In standard telePRO, outpatient follow-up activity is determined by a clinician and patients receive a questionnaire at fixed intervals. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females from Age 15 years
- Diagnosis of epilepsy
- Referred to standard telePRO by a clinician
- Access to internet (web-responders in standard telePRO)
- Can speak and understand Danish
Key exclusion criteria (2 listed)
- Paper responders
- Referred to telePRO proxy questionnaire
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 |
|---|---|---|
| Open Access telePROIn open access, contacts to the outpatient clinic are initiated solely by the patient. Contacts may be in the form of a PRO assessment like in standard telePRO, but at a time decided by the patient via the Danish National Health website "Sundhed.dk". | Other | Open Access telePRO |
| Standard telePROStandard care: fixed interval telePRO follow-up. Patients receive a questionnaire with individually pre-specified intervals. | Other | Standard telePRO |
Primary outcome
Number of contacts
Time frame: 18 months
Number of contacts includes all contacts with the outpatient clinic in the study follow-up period
10 secondary outcomes
General health will be assessed by items from the SF-36 questionnaire
Time frame: 18 months
Well-being wil be assessed by the WHO-5 Well-being Index
Time frame: 18 months
Mortality
Time frame: 18 months
Number of seizures
Time frame: 18 months
Side effects
Time frame: 18 months
Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 4, 6, and 9)
Time frame: 18 months
Self-efficacy will be assessed by The General Self-Efficacy Scale
Time frame: 18 months
Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Time frame: 18 months
Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Time frame: 18 months
Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Time frame: 18 months
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 21 May 2018.
- Derived from this study: PubMed 31520247Schougaard LMV, Mejdahl CT, Christensen J, Lomborg K, Maindal HT, de Thurah A, Hjollund NH. Patient-initiated versus fixed-interval patient-reported outcome-based follow-up in outpatients with epilepsy: a pragmatic randomized controlled trial. J Patient Rep Outcomes. 2019 Sep 13;3(1):61. doi: 10.1186/s41687-019-0151-0.
- Derived from this study: PubMed 28122609Schougaard LM, Mejdahl CT, Petersen KH, Jessen A, de Thurah A, Sidenius P, Lomborg K, Hjollund NH. Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study. BMC Health Serv Res. 2017 Jan 26;17(1):83. doi: 10.1186/s12913-017-2015-8.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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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.
Niels Henrik Hjollund, Professor study director
Regional Hospital West Jutland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Access telePRO and Standard telePRO in people with Epilepsy, run by University of Aarhus at 1 site in Denmark.
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 5 inclusion and 2 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 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of contacts (time frame: 18 months). 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 NCT02673580, which also lists 2 linked publications.
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 21 May 2018.