NCT02382081

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 2, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

2.8 years

First QC Date

March 2, 2015

Last Update Submit

February 16, 2018

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Dermatology life quality index (DLQI)

    Evaluation of quality of life

    2 years

Secondary Outcomes (9)

  • SF36 - Short Form 36 (SF-36)

    2 years

  • Psoriasis Area and Severity Index (PASI

    2 years

  • Hospital Anxiety and Depression Scale (HADS)

    2 years

  • Body Image Scale (BIS)

    2 years

  • Self-developed patient safety scale

    2 years

  • +4 more secondary outcomes

Study Arms (2)

Patient-initiated shared care

EXPERIMENTAL

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

Control

NO INTERVENTION

Traditional, routine hospital reviews every three-fourth month.

Interventions

Patient-initiated shared carePROCEDURE
Patient-initiated shared care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte Hospital, University of Copenhagen

Copenhagen, 2900, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 29363093DERIVED

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.N., stud.cand.scient.sant

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 6, 2015

Study Start

May 2, 2015

Primary Completion

February 17, 2018

Study Completion

February 17, 2018

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

DK(1)