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Clinical Trials/NCT01352780
NCT01352780UnknownPhase 3

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

Oslo University Hospital2 sites in 1 country169 target enrollmentStarted: September 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Sponsor
Enrollment
169
Locations
2
Primary Endpoint
HeiQ

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
20 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

usual care

No Intervention

Motivational interviewing

Intervention: Motivational interviewing (Behavioral)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • 15D(Change in 15D from baseline to 6 weeks and 12 weeks)
  • Questionnaire about lifestyle(Change in lifestyle parametres from baseline to 6 weeks and 12 weeks)
  • Psoriasis Knowledge questionnaire(change in knowledge from baseline to 3 weeks, 3 months and 6 monthts)
  • Willingness to change to manage psoriasis(change from baseline to 3 months and 6 months)
  • BIPQ-2(Change from baseline to 3 and 6 months)

Investigators

Sponsor
Oslo University Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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