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

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Open Access telePRO
Standard telePRO
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Epilepsy

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regional Hospital West Jutland

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Open Access telePRO

Standard telePRO

Arm Description

Intervention: In open access, contact to the outpatient clinic is initiated by the patient by filling in a PRO questionnaire.

No intervention: In standard telePRO, outpatient follow-up activity is determined by a clinician and patients receive a questionnaire at fixed intervals.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

General health will be assessed by items from the SF-36 questionnaire
General health will be measured at baseline and after 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.
Mortality
Mortality will be measured after 18 months.
Number of seizures
Difference number of seizures (start - end) and will be measured at baseline and after 18 months.
Side effects
Side effects will be measured at baseline and after 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.
Self-efficacy will be assessed by The General Self-Efficacy Scale
Self-efficacy will be measured at baseline and after 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.
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.
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.

Full Information

First Posted
January 28, 2016
Last Updated
May 18, 2018
Sponsor
University of Aarhus
Collaborators
Central Denmark Region, TrygFonden, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02673580
Brief Title
Tele-patient-reported Outcomes (telePRO) in Clinical Practice
Official Title
Tele-patient-reported Outcomes (telePRO) in Clinical Practice - Effect of Patient-initiated Versus Fixed Interval telePRO Based Outpatient Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Central Denmark Region, TrygFonden, Denmark

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
593 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Access telePRO
Arm Type
Other
Arm Description
Intervention: In open access, contact to the outpatient clinic is initiated by the patient by filling in a PRO questionnaire.
Arm Title
Standard telePRO
Arm Type
Other
Arm Description
No intervention: In standard telePRO, outpatient follow-up activity is determined by a clinician and patients receive a questionnaire at fixed intervals.
Intervention Type
Other
Intervention Name(s)
Open Access telePRO
Intervention Description
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".
Intervention Type
Other
Intervention Name(s)
Standard telePRO
Intervention Description
Standard care: fixed interval telePRO follow-up. Patients receive a questionnaire with individually pre-specified intervals.
Primary Outcome Measure Information:
Title
Number of contacts
Description
Number of contacts includes all contacts with the outpatient clinic in the study follow-up period
Time Frame
18 months
Secondary Outcome Measure Information:
Title
General health will be assessed by items from the SF-36 questionnaire
Description
General health will be measured at baseline and after 18 months.
Time Frame
18 months
Title
Well-being wil be assessed by the WHO-5 Well-being Index
Description
Well-being will be measured at baseline and after 18 months.
Time Frame
18 months
Title
Mortality
Description
Mortality will be measured after 18 months.
Time Frame
18 months
Title
Number of seizures
Description
Difference number of seizures (start - end) and will be measured at baseline and after 18 months.
Time Frame
18 months
Title
Side effects
Description
Side effects will be measured at baseline and after 18 months.
Time Frame
18 months
Title
Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 4, 6, and 9)
Description
Health literacy will be measured at baseline and after 18 months.
Time Frame
18 months
Title
Self-efficacy will be assessed by The General Self-Efficacy Scale
Description
Self-efficacy will be measured at baseline and after 18 months.
Time Frame
18 months
Title
Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Description
Confidence will be measured at baseline and after 18 months.
Time Frame
18 months
Title
Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Description
Safety will be measured at baseline and after 18 months.
Time Frame
18 months
Title
Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Description
Satisfaction will be measured at baseline and after 18 months.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Henrik Hjollund, Professor
Organizational Affiliation
Regional Hospital West Jutland
Official's Role
Study Director
Facility Information:
Facility Name
Regional Hospital West Jutland
City
Herning
State/Province
Central Denmark Region
ZIP/Postal Code
7400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31520247
Citation
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.
Results Reference
derived
PubMed Identifier
28122609
Citation
Schougaard 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.
Results Reference
derived

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

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