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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02673580
Date of registration:	28/01/2016
Prospective Registration:	No
Primary sponsor:	University of Aarhus
Public title:	Tele-patient-reported Outcomes (telePRO) in Clinical Practice
Scientific title:	Tele-patient-reported Outcomes (telePRO) in Clinical Practice - Effect of Patient-initiated Versus Fixed Interval telePRO Based Outpatient Follow-up
Date of first enrolment:	January 2016
Target sample size:	593
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02673580
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Denmark

Contacts

Name:	Niels Henrik Hjollund, Professor
Address:
Telephone:
Email:
Affiliation:	Regional Hospital West Jutland

Key inclusion & exclusion 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

Age minimum: 15 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Other: Standard telePRO

Other: Open Access telePRO

Primary Outcome(s)

Number of contacts [Time Frame: 18 months]

Secondary Outcome(s)

General health will be assessed by items from the SF-36 questionnaire [Time Frame: 18 months]

Mortality [Time Frame: 18 months]

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

Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire [Time Frame: 18 months]

Number of seizures [Time Frame: 18 months]

Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire [Time Frame: 18 months]

Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire [Time Frame: 18 months]

Self-efficacy will be assessed by The General Self-Efficacy Scale [Time Frame: 18 months]

Well-being wil be assessed by the WHO-5 Well-being Index [Time Frame: 18 months]

Side effects [Time Frame: 18 months]

Secondary ID(s)

TELEPRO

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

TrygFonden, Denmark

Central Denmark Region

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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