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

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ClinicalTrials.gov Identifier: NCT02673580
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : May 21, 2018
Sponsor:
Collaborators:
Central Denmark Region
TrygFonden, Denmark
Information provided by (Responsible Party):
University of Aarhus

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)

Condition or disease Intervention/treatment Phase
Epilepsy Other: Open Access telePRO Other: Standard telePRO Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 593 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Tele-patient-reported Outcomes (telePRO) in Clinical Practice - Effect of Patient-initiated Versus Fixed Interval telePRO Based Outpatient Follow-up
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Open Access telePRO
Intervention: In open access, contact to the outpatient clinic is initiated by the patient by filling in a PRO questionnaire.
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
No intervention: In standard telePRO, outpatient follow-up activity is determined by a clinician and patients receive a questionnaire at fixed intervals.
Other: Standard telePRO
Standard care: fixed interval telePRO follow-up. Patients receive a questionnaire with individually pre-specified intervals.




Primary Outcome Measures :
  1. Number of contacts [ Time Frame: 18 months ]
    Number of contacts includes all contacts with the outpatient clinic in the study follow-up period


Secondary Outcome Measures :
  1. General health will be assessed by items from the SF-36 questionnaire [ Time Frame: 18 months ]
    General health will be measured at baseline and after 18 months.

  2. Well-being wil be assessed by the WHO-5 Well-being Index [ Time Frame: 18 months ]
    Well-being will be measured at baseline and after 18 months.

  3. Mortality [ Time Frame: 18 months ]
    Mortality will be measured after 18 months.

  4. Number of seizures [ Time Frame: 18 months ]
    Difference number of seizures (start - end) and will be measured at baseline and after 18 months.

  5. Side effects [ Time Frame: 18 months ]
    Side effects will be measured at baseline and after 18 months.

  6. Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 4, 6, and 9) [ Time Frame: 18 months ]
    Health literacy will be measured at baseline and after 18 months.

  7. Self-efficacy will be assessed by The General Self-Efficacy Scale [ Time Frame: 18 months ]
    Self-efficacy will be measured at baseline and after 18 months.

  8. Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire [ Time Frame: 18 months ]
    Confidence will be measured at baseline and after 18 months.

  9. Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire [ Time Frame: 18 months ]
    Safety will be measured at baseline and after 18 months.

  10. Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire [ Time Frame: 18 months ]
    Satisfaction will be measured at baseline and after 18 months.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673580


Locations
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Denmark
Regional Hospital West Jutland
Herning, Central Denmark Region, Denmark, 7400
Sponsors and Collaborators
University of Aarhus
Central Denmark Region
TrygFonden, Denmark
Investigators
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Study Director: Niels Henrik Hjollund, Professor Regional Hospital West Jutland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02673580     History of Changes
Other Study ID Numbers: TELEPRO
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases