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Clinical Trials/NCT02673580
NCT02673580
Completed
Not Applicable

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

University of Aarhus1 site in 1 country593 target enrollmentJanuary 2016
ConditionsEpilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
University of Aarhus
Enrollment
593
Locations
1
Primary Endpoint
Number of contacts
Status
Completed
Last Updated
7 years ago

Overview

Brief 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)

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
January 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of contacts

Time Frame: 18 months

Number of contacts includes all contacts with the outpatient clinic in the study follow-up period

Secondary Outcomes

  • Mortality(18 months)
  • Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 4, 6, and 9)(18 months)
  • Self-efficacy will be assessed by The General Self-Efficacy Scale(18 months)
  • Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire(18 months)
  • General health will be assessed by items from the SF-36 questionnaire(18 months)
  • Well-being wil be assessed by the WHO-5 Well-being Index(18 months)
  • Number of seizures(18 months)
  • Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire(18 months)
  • Side effects(18 months)
  • Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire(18 months)

Study Sites (1)

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