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

Psoriasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382081
• Other study ID #: Behov
• Status: Completed
• Phase: N/A
• First received: March 2, 2015
• Last updated: February 16, 2018
• Start date: May 2, 2015
• Est. completion date: February 17, 2018

Study information

• Verified date: February 2018
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 17, 2018
• Est. primary completion date: February 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Procedure:
• Patient-initiated shared care

Locations

Country	Name	City	State
Denmark	Gentofte Hospital, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dermatology life quality index (DLQI)	Evaluation of quality of life	2 years
Secondary	SF36 - Short Form 36 (SF-36)		2 years
Secondary	Psoriasis Area and Severity Index (PASI		2 years
Secondary	Hospital Anxiety and Depression Scale (HADS)		2 years
Secondary	Body Image Scale (BIS)		2 years
Secondary	Self-developed patient safety scale		2 years
Secondary	Hospital visits		2 years
Secondary	Numbers of phone calls to the nurse-run telephone helpline		2 years
Secondary	Adherence to medicine treatment		2 years
Secondary	Charlson Comorbidity Index		2 years