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CompletedNCT02382081Updated Feb 19, 2018

A Randomized Control Trial of Patient-initiated Hospital Follow-up for Patients With Psoriasis

An interventional study of Patient-initiated shared care in Psoriasis, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-19.

Sponsored by University Hospital, Gentofte, Copenhagen · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The primary objective of this research protocol is to evaluate the health related quality of life and efficacy of patient-initiated hospital follow-up for patients with moderate to severe psoriasis.

Read the detailed description

Psoriasis is a chronic inflammatory skin disease affecting 1 to 3% of the European population. Treatment of moderate to severe psoriasis often requires lifetime routine reviews by hospital dermatologist. Patterns of hospital review vary, but most patients attend follow-up every 12-16 week by dermatologist. At routine reviews the patient disease is often quiet and little intervention or no intervention is required, and times were the patient need help the time is limited for in-depth consultation. Both patient and healthcare professional requested more time. In-depth consultation is important in the care of psoriasis, because moderate to severe psoriasis has a significant impact on quality of life and patient have an increased incidence of cardiovascular risk factors such as hypertension, overweight, hyperlipidemia and exposure to tobacco and alcohol. These comorbidities and the psychosocial burden must be addressed by clinicians to help patients to acquire or to maintain competencies that are required to live with a chronic disease.

Patient-initiated hospital follow-up for patients with moderate to severe psoriasis might reduce inappropriate follow-up appointments, improve rapid access to specialist care and release resource to further in-depth consultation. If the patient is empowered to initiate hospital review thus patient's individual needs dictate the content, duration and contact with clinicians. It is our goal that an individual needs-based patient involvement in the shape of patient-initiated hospital follow-up,will be perceived as a benefit of the patients who 1) meets a high safety in the patient's own provision of medical treatment, 2) increase the patient's knowledge of the lifestyle and prevention of comorbidities and 3) strengths patient's overall satisfaction with treatment.

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Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 150 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients in stable systemic psoriasis treatment defined as having received treatment for more then 12 weeks without complication and being adherence to medication administration.

Exclusion criteria

Exclusion Criteria:

  • Patients not able to give informed consent
  • Patients not able to follow the program
  • Patient with server psychiatric diseases
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Patient-initiated shared care

    Patient-initiated shared care hospital reviews in which there were one planed hospital review every year and if needed additional reviews initiated by the patient. Access to nurse-run telephone helpline with direct access to a contact nurse.

    Procedure: Patient-initiated shared care

  • No intervention
    Control

    Traditional, routine hospital reviews every three-fourth month.

Interventions

  • ProcedurePatient-initiated shared care
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What researchers measure

Primary outcomes

  1. Dermatology life quality index (DLQI)

    Evaluation of quality of life

    Time frame: 2 years

Secondary outcomes

  1. SF36 - Short Form 36 (SF-36)

    Time frame: 2 years

  2. Psoriasis Area and Severity Index (PASI

    Time frame: 2 years

  3. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 2 years

  4. Body Image Scale (BIS)

    Time frame: 2 years

  5. Self-developed patient safety scale

    Time frame: 2 years

  6. Hospital visits

    Time frame: 2 years

  7. Numbers of phone calls to the nurse-run telephone helpline

    Time frame: 2 years

  8. Adherence to medicine treatment

    Time frame: 2 years

  9. Charlson Comorbidity Index

    Time frame: 2 years

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Study locations

1 site
  • Gentofte Hospital, University of Copenhagen
    Copenhagen, 2900, Denmark
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References and documents

Publications

  • Khoury LR, Moller T, Zachariae C, Skov L. A prospective 52-week randomized controlled trial of patient-initiated care consultations for patients with psoriasis. Br J Dermatol. 2018 Aug;179(2):301-308. doi: 10.1111/bjd.16369. Epub 2018 May 23. PubMed 29363093 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02382081
Lead sponsor
University Hospital, Gentofte, Copenhagen
Responsible party
Lina R. Khoury (B.N., stud.cand.scient.sant, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
Mar 6, 2015
Start date
May 2, 2015
Primary completion
Feb 17, 2018
Completion
Feb 17, 2018
Last update
Feb 19, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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