Clinical trial NCT02382081: A Randomized Control Trial of Patient-initiated Hospital Follow-up for Patients With Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dermatology life quality index (DLQI)
timeFrame: 2 years
Secondary outcomes:
measure: SF36 - Short Form 36 (SF-36)
timeFrame: 2 years
measure: Psoriasis Area and Severity Index (PASI
timeFrame: 2 years
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 2 years
measure: Body Image Scale (BIS)
timeFrame: 2 years
measure: Self-developed patient safety scale
timeFrame: 2 years
measure: Hospital visits
timeFrame: 2 years
measure: Numbers of phone calls to the nurse-run telephone helpline
timeFrame: 2 years
measure: Adherence to medicine treatment
timeFrame: 2 years
measure: Charlson Comorbidity Index
timeFrame: 2 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Gentofte Hospital, University of Copenhagen
Study officials:
References:
citation: 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.