Psoriasis and Climate Therapy- Effect of Motivational Follow- up Calls on Clinical and Health Economic Parameters

Psoriasis Clinical Trial

Official title:

Psoriasis and Climate Therapy- Effect of Motivational Follow- up Calls on Clinical and Health Economic Parameters

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01352780
• Other study ID #: OsloUHBHR
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 11, 2011
• Last updated: May 28, 2015
• Start date: September 2011
• Est. completion date: June 2016

Study information

• Verified date: October 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: University of Oslo, Departement of Health and Society
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate clinical and health economic parameters in relation to individual motivational counseling by phone.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 169
• Est. completion date: June 2016
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Conducted 3 weeks of supervised climate therapy in The Canary Islands

• Able to write and communicate in Norwegian

• PASI more than 7 on application

Exclusion Criteria:

• more than 5 climate therapy treatments during the last 10 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Psoriasis

Intervention

Behavioral:
• Motivational interviewing
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.

Locations

Country	Name	City	State
Norway	Oslo University hospital, Department for clima therapy	Oslo
Norway	University of Oslo, Departement of health and society	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change in SAPASI from baseline, to 3 weeks, 6 weeks and 12 weeks	No
Primary	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.	change from baseline to 3 months, 6 months	No
Secondary	15D	The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults (age 16+ years).	Change in 15D from baseline to 6 weeks and 12 weeks	No
Secondary	Questionnaire about lifestyle	Questions about exercise, diet, stress, lifestyle change	Change in lifestyle parametres from baseline to 6 weeks and 12 weeks	No
Secondary	BIPQ-2	short questionnaire about illness perception	Change from baseline to 3 and 6 months	No
Secondary	Psoriasis Knowledge questionnaire	40 questions about psoriasis and psoriasis treatment	change in knowledge from baseline to 3 weeks, 3 months and 6 monthts	No
Secondary	Willingness to change to manage psoriasis	8 questions about plans for change or conducted change managing psoriasis symptoms	change from baseline to 3 months and 6 months	No

External Links

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