A Randomized Control Trial of Patient-initiated Hospital Follow-up for Patients With Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Patient-initiated shared care
Sponsored by
About this trial
This is an interventional supportive care trial for Psoriasis
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
Sites / Locations
- Gentofte Hospital, University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patient-initiated shared care
Control
Arm Description
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.
Traditional, routine hospital reviews every three-fourth month.
Outcomes
Primary Outcome Measures
Dermatology life quality index (DLQI)
Evaluation of quality of life
Secondary Outcome Measures
SF36 - Short Form 36 (SF-36)
Psoriasis Area and Severity Index (PASI
Hospital Anxiety and Depression Scale (HADS)
Body Image Scale (BIS)
Self-developed patient safety scale
Hospital visits
Numbers of phone calls to the nurse-run telephone helpline
Adherence to medicine treatment
Charlson Comorbidity Index
Full Information
NCT ID
NCT02382081
First Posted
March 2, 2015
Last Updated
February 16, 2018
Sponsor
University Hospital, Gentofte, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT02382081
Brief Title
A Randomized Control Trial of Patient-initiated Hospital Follow-up for Patients With Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2015 (undefined)
Primary Completion Date
February 17, 2018 (Actual)
Study Completion Date
February 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient-initiated shared care
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Traditional, routine hospital reviews every three-fourth month.
Intervention Type
Procedure
Intervention Name(s)
Patient-initiated shared care
Primary Outcome Measure Information:
Title
Dermatology life quality index (DLQI)
Description
Evaluation of quality of life
Time Frame
2 years
Secondary Outcome Measure Information:
Title
SF36 - Short Form 36 (SF-36)
Time Frame
2 years
Title
Psoriasis Area and Severity Index (PASI
Time Frame
2 years
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
2 years
Title
Body Image Scale (BIS)
Time Frame
2 years
Title
Self-developed patient safety scale
Time Frame
2 years
Title
Hospital visits
Time Frame
2 years
Title
Numbers of phone calls to the nurse-run telephone helpline
Time Frame
2 years
Title
Adherence to medicine treatment
Time Frame
2 years
Title
Charlson Comorbidity Index
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Gentofte Hospital, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2900
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
29363093
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.
Results Reference
derived
Learn more about this trial
A Randomized Control Trial of Patient-initiated Hospital Follow-up for Patients With Psoriasis
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