PsoriasisPhase 3NCT01352780
Psoriasis and Climate Therapy- Effect of Motivational Follow- up Calls on Clinical and Health Economic Parameters
A Phase 3 study testing Motivational interviewing in people with Psoriasis, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
The aim of this study is to evaluate clinical and health economic parameters in relation to individual motivational counseling by phone. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 2 sitesNorway
- Study dates
- Sep 2011to Jun 2016
- Phase
- Phase 3
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Conducted 3 weeks of supervised climate therapy in The Canary Islands
- Able to write and communicate in Norwegian
- PASI more than 7 on application
Who cannot join
- more than 5 climate therapy treatments during the last 10 years
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo University hospital, Department for clima therapy
Oslo, Oslo, 0027
University of Oslo, Departement of health and society
Oslo
About this study
The aim of this study is to evaluate clinical and health economic parameters in relation to individual motivational counseling by phone.
Read the detailed description
A chronic condition such as psoriasis requires a high level of self- management and requires for many patients behaviour change to improve health outcome. Changing behaviour is a challenge that requires a commitment by the patient to implement successfully. Motivational interviewing is a patient centered directive counseling technique that focuses on assisting patients to identify their problems and involves exploring ambivalence in an empathic manner. It is a well-known method of counseling, and is considered to be a useful intervention strategy in the treatment of lifestyle problems.
This study is a randomized controlled trial using telephone motivational interviewing. The counseling intervention comprises 6 telephone calls during a 12 week period, after attending 3 weeks of supervised climate therapy on the Canary Islands
- Conditions
- Psoriasis
- Being tested
- Motivational interviewing
- Keywords
- motivational interviewing, psoriasis, self management
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
Motivational interviewing technique will be used to improve patient adherence to multiple health behaviour changes and support patients with psoriasis to self- manage effectively. The intervention will discuss on four main topics: diet, physical activity, stress management and psoriasis treatment.
Motivational interviewing is a patient centered directive counselling technique that focuses on assisting patients to identify their problems and involves exploring ambivalence in an empathic manner. A key goal in motivational interviewing is to increase the importance of change from the client's perspective. This is accomplished by using specific types of open ended questions, selective reflections and reflective listening.
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | Motivational interviewing Receives: Behavioral: Motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAPASI (+ PASI at T1 and T2)
The self-administered psoriasis area and severity index (SAPASI) is a structured instrument for measuring the severity of psoriasis.
Measured: Change in SAPASI from baseline, to 3 weeks, 6 weeks and 12 weeks
HeiQ
The heiQ™ is an Australian-developed health education impact evaluation system. It consists of a set of eight scales. Each scale is an independent questionnaire and together they provide a comprehensive profile of the intended outcomes of health education / self-management programs.
Measured: change from baseline to 3 months, 6 months
Secondary outcomes (5)
15D
The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults (age 16+ years).
Measured: Change in 15D from baseline to 6 weeks and 12 weeks
Questionnaire about lifestyle
Questions about exercise, diet, stress, lifestyle change
Measured: Change in lifestyle parametres from baseline to 6 weeks and 12 weeks
BIPQ-2
short questionnaire about illness perception
Measured: Change from baseline to 3 and 6 months
Psoriasis Knowledge questionnaire
40 questions about psoriasis and psoriasis treatment
Measured: change in knowledge from baseline to 3 weeks, 3 months and 6 monthts
Willingness to change to manage psoriasis
8 questions about plans for change or conducted change managing psoriasis symptoms
Measured: change from baseline to 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Astrid K. Wahl, PhD, Study chair, University of Oslo, Departement of Health and Society,Department of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352780
- Sponsor's protocol ID
- OsloUHBHR
- Status last verified
- Oct 2014
- First submitted
- 11 May 2011
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psoriasis and Climate Therapy- Effect of Motivational Follow- up Calls on Clinical and Health Economic Parameters
- ClinicalTrials.gov ID
- NCT01352780
- Acronym / sponsor ID
- OsloUHBHR
- Conditions
- Psoriasis
- Keywords
- motivational interviewing, psoriasis, self management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 12 May 2011 (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 aim of this study is to evaluate clinical and health economic parameters in relation to individual motivational counseling by phone.
Detailed description
A chronic condition such as psoriasis requires a high level of self- management and requires for many patients behaviour change to improve health outcome. Changing behaviour is a challenge that requires a commitment by the patient to implement successfully. Motivational interviewing is a patient centered directive counseling technique that focuses on assisting patients to identify their problems and involves exploring ambivalence in an empathic manner. It is a well-known method of counseling, and is considered to be a useful intervention strategy in the treatment of lifestyle problems.
This study is a randomized controlled trial using telephone motivational interviewing. The counseling intervention comprises 6 telephone calls during a 12 week period, after attending 3 weeks of supervised climate therapy on the Canary Islands
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | Behavioral: Motivational interviewingMotivational interviewing |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Conducted 3 weeks of supervised climate therapy in The Canary Islands
- Able to write and communicate in Norwegian
- PASI more than 7 on application
Key exclusion criteria (1 listed)
- more than 5 climate therapy treatments during the last 10 years
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 |
|---|---|---|
| Motivational interviewingMotivational interviewing technique will be used to improve patient adherence to multiple health behaviour changes and support patients with psoriasis to self- manage effectively. The intervention will discuss on four main topics: diet, physical activity, stress management and psoriasis treatment. Motivational interviewing is a patient centered directive counselling technique that focuses on assisting patients to identify their problems and involves exploring ambivalence in an empathic manner. A key goal in motivational interviewing is to increase the importance of change from the client's perspective. This is accomplished by using specific types of open ended questions, selective reflections and reflective listening. | Behavioural | usual care |
Primary outcome
SAPASI (+ PASI at T1 and T2)
Time frame: Change in SAPASI from baseline, to 3 weeks, 6 weeks and 12 weeks
The self-administered psoriasis area and severity index (SAPASI) is a structured instrument for measuring the severity of psoriasis.
HeiQ
Time frame: change from baseline to 3 months, 6 months
The heiQ™ is an Australian-developed health education impact evaluation system. It consists of a set of eight scales. Each scale is an independent questionnaire and together they provide a comprehensive profile of the intended outcomes of health education / self-management programs.
5 secondary outcomes
15D
Time frame: Change in 15D from baseline to 6 weeks and 12 weeks
Questionnaire about lifestyle
Time frame: Change in lifestyle parametres from baseline to 6 weeks and 12 weeks
BIPQ-2
Time frame: Change from baseline to 3 and 6 months
Psoriasis Knowledge questionnaire
Time frame: change in knowledge from baseline to 3 weeks, 3 months and 6 monthts
Willingness to change to manage psoriasis
Time frame: change from baseline to 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Related InfoLink provided by the sponsor.
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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.
Astrid K. Wahl, PhD study chair
University of Oslo, Departement of Health and Society,Department of Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Motivational interviewing in people with Psoriasis, run by Oslo University Hospital at 2 sites in Norway.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
SAPASI (+ PASI at T1 and T2) (time frame: Change in SAPASI from baseline, to 3 weeks, 6 weeks and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2015.