Tele-patient-reported Outcomes (telePRO) in Clinical Practice

Epilepsy Clinical Trial

Official title:

Tele-patient-reported Outcomes (telePRO) in Clinical Practice - Effect of Patient-initiated Versus Fixed Interval telePRO Based Outpatient Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673580
• Other study ID #: TELEPRO
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 593
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Paper responders

• Referred to telePRO proxy questionnaire

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Open Access telePRO
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 telePRO
Standard care: fixed interval telePRO follow-up. Patients receive a questionnaire with individually pre-specified intervals.

Locations

Country	Name	City	State
Denmark	Regional Hospital West Jutland	Herning	Central Denmark Region

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Central Denmark Region, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of contacts	Number of contacts includes all contacts with the outpatient clinic in the study follow-up period	18 months
Secondary	General health will be assessed by items from the SF-36 questionnaire	General health will be measured at baseline and after 18 months.	18 months
Secondary	Well-being wil be assessed by the WHO-5 Well-being Index	Well-being will be measured at baseline and after 18 months.	18 months
Secondary	Mortality	Mortality will be measured after 18 months.	18 months
Secondary	Number of seizures	Difference number of seizures (start - end) and will be measured at baseline and after 18 months.	18 months
Secondary	Side effects	Side effects will be measured at baseline and after 18 months.	18 months
Secondary	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.	18 months
Secondary	Self-efficacy will be assessed by The General Self-Efficacy Scale	Self-efficacy will be measured at baseline and after 18 months.	18 months
Secondary	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.	18 months
Secondary	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.	18 months
Secondary	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.	18 months