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

Phase 3

• Conditions: Psoriasis
• Interventions: Behavioral: Motivational interviewing

• Registration Number: NCT01352780
• Lead Sponsor: Oslo University Hospital

Brief Summary

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 Timeline

• Study First Submitted: 2011-05-11
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-12
• Study Start: 2011-09
• Primary Completion: 2012-12
• Status Verified: 2014-10
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 169

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
usual care	Motivational interviewing	Motivational interviewing

Primary Outcome Measures

Name	Time	Method
SAPASI (+ PASI at T1 and T2)	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	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.

Secondary Outcome Measures

Name	Time	Method
15D	Change in 15D from baseline to 6 weeks and 12 weeks	The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults (age 16+ years).
Questionnaire about lifestyle	Change in lifestyle parametres from baseline to 6 weeks and 12 weeks	Questions about exercise, diet, stress, lifestyle change
Psoriasis Knowledge questionnaire	change in knowledge from baseline to 3 weeks, 3 months and 6 monthts	40 questions about psoriasis and psoriasis treatment
Willingness to change to manage psoriasis	change from baseline to 3 months and 6 months	8 questions about plans for change or conducted change managing psoriasis symptoms
BIPQ-2	Change from baseline to 3 and 6 months	short questionnaire about illness perception

Trial Locations

Locations (2)

Oslo University hospital, Department for clima therapy; 🇳🇴 Oslo, Norway

University of Oslo, Departement of health and society; 🇳🇴 Oslo, Norway