NCT01352780

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
169

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 29, 2015

Status Verified

October 1, 2014

Enrollment Period

1.3 years

First QC Date

May 11, 2011

Last Update Submit

May 28, 2015

Conditions

Keywords

motivational interviewingpsoriasisself management

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (5)

  • 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

  • BIPQ-2

    Change from baseline to 3 and 6 months

  • 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

Study Arms (1)

usual care

NO INTERVENTION

Motivational interviewing

Behavioral: Motivational interviewing

Interventions

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.

usual care

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Conducted 3 weeks of supervised climate therapy in The Canary Islands
  • Able to write and communicate in Norwegian
  • PASI more than 7 on application

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oslo University hospital, Department for clima therapy

Oslo, Oslo County, 0027, Norway

Location

University of Oslo, Departement of health and society

Oslo, Norway

Location

Related Links

MeSH Terms

Conditions

Psoriasis

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Astrid K. Wahl, PhD

    University of Oslo, Departement of Health and Society,Department of Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2011

First Posted

May 12, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

June 1, 2016

Last Updated

May 29, 2015

Record last verified: 2014-10

Locations