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Completed

NCT Number: NCT02382081

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gentofte Hospital, University of Copenhagen

Copenhagen, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

Patient-initiated shared care

Procedure

Primary outcomes

  1. Dermatology life quality index (DLQI)

    Time frame: 2 years

    Evaluation of quality of life

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

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 6, 2015
Registry last updated
Feb 19, 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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