PsoriasisNCT02382081
A Randomized Control Trial of Patient-initiated Hospital Follow-up for Patients With Psoriasis
A study testing Patient-initiated shared care in people with Psoriasis, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Patient-initiated shared care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 2 May 2015to 17 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in stable systemic psoriasis treatment defined as having received treatment for more then 12 weeks without complication and being adherence to medication administration.
Who cannot join
- Patients not able to give informed consent
- Patients not able to follow the program
- Patient with server psychiatric diseases
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Patient-initiated shared care
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-initiated shared careProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Patient-initiated shared care |
| Control | No intervention | Traditional, routine hospital reviews every three-fourth month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatology life quality index (DLQI)
Evaluation of quality of life
Measured: 2 years
Secondary outcomes (9)
SF36 - Short Form 36 (SF-36)
Measured: 2 years
Psoriasis Area and Severity Index (PASI
Measured: 2 years
Hospital Anxiety and Depression Scale (HADS)
Measured: 2 years
Body Image Scale (BIS)
Measured: 2 years
Self-developed patient safety scale
Measured: 2 years
Hospital visits
Measured: 2 years
Numbers of phone calls to the nurse-run telephone helpline
Measured: 2 years
Adherence to medicine treatment
Measured: 2 years
Charlson Comorbidity Index
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study start2 May 2015
- Primary completion17 Feb 2018
- Study completion17 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lina R. Khoury, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382081
- Sponsor's protocol ID
- Behov
- Status last verified
- Feb 2018
- First submitted
- 2 Mar 2015
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29363093
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Patient-initiated Hospital Follow-up for Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT02382081
- Acronym / sponsor ID
- Behov
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 2 May 2015
- Primary completion
- 17 Feb 2018 (actual)
- Study completion
- 17 Feb 2018 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-initiated shared care | Experimental | Procedure: Patient-initiated shared carePatient-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. |
| Control | No intervention | –Traditional, routine hospital reviews every three-fourth month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in stable systemic psoriasis treatment defined as having received treatment for more then 12 weeks without complication and being adherence to medication administration.
Key exclusion criteria (3 listed)
- Patients not able to give informed consent
- Patients not able to follow the program
- Patient with server psychiatric diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-initiated shared care | Procedure or surgery | Patient-initiated shared care |
Primary outcome
Dermatology life quality index (DLQI)
Time frame: 2 years
Evaluation of quality of life
9 secondary outcomes
SF36 - Short Form 36 (SF-36)
Time frame: 2 years
Psoriasis Area and Severity Index (PASI
Time frame: 2 years
Hospital Anxiety and Depression Scale (HADS)
Time frame: 2 years
Body Image Scale (BIS)
Time frame: 2 years
Self-developed patient safety scale
Time frame: 2 years
Hospital visits
Time frame: 2 years
Numbers of phone calls to the nurse-run telephone helpline
Time frame: 2 years
Adherence to medicine treatment
Time frame: 2 years
Charlson Comorbidity Index
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Derived from this study: PubMed 29363093Khoury 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-initiated shared care in people with Psoriasis, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dermatology life quality index (DLQI) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02382081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.