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OpenTrials
Completed

NCT Number: NCT02673580

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

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)

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Hospital West Jutland

Herning, Central Jutland, 7400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open Access telePRO

Other

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

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Central Denmark Region
  • TrygFonden, Denmark

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 4, 2016
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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