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

Primary Purpose

Psoriasis

Status
Unknown status
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Motivational interviewing
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Psoriasis focused on measuring motivational interviewing, psoriasis, self management

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University hospital, Department for clima therapy
  • University of Oslo, Departement of health and society

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

usual care

Arm Description

Motivational interviewing

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

15D
The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults (age 16+ years).
Questionnaire about lifestyle
Questions about exercise, diet, stress, lifestyle change
BIPQ-2
short questionnaire about illness perception
Psoriasis Knowledge questionnaire
40 questions about psoriasis and psoriasis treatment
Willingness to change to manage psoriasis
8 questions about plans for change or conducted change managing psoriasis symptoms

Full Information

First Posted
May 11, 2011
Last Updated
May 28, 2015
Sponsor
Oslo University Hospital
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT01352780
Brief Title
Psoriasis and Climate Therapy- Effect of Motivational Follow- up Calls on Clinical and Health Economic Parameters
Official Title
Psoriasis and Climate Therapy- Effect of Motivational Follow- up Calls on Clinical and Health Economic Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
Collaborators
University of Oslo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
motivational interviewing, psoriasis, self management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual care
Arm Type
No Intervention
Arm Description
Motivational interviewing
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing
Intervention Description
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.
Primary Outcome Measure Information:
Title
SAPASI (+ PASI at T1 and T2)
Description
The self-administered psoriasis area and severity index (SAPASI) is a structured instrument for measuring the severity of psoriasis.
Time Frame
Change in SAPASI from baseline, to 3 weeks, 6 weeks and 12 weeks
Title
HeiQ
Description
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.
Time Frame
change from baseline to 3 months, 6 months
Secondary Outcome Measure Information:
Title
15D
Description
The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults (age 16+ years).
Time Frame
Change in 15D from baseline to 6 weeks and 12 weeks
Title
Questionnaire about lifestyle
Description
Questions about exercise, diet, stress, lifestyle change
Time Frame
Change in lifestyle parametres from baseline to 6 weeks and 12 weeks
Title
BIPQ-2
Description
short questionnaire about illness perception
Time Frame
Change from baseline to 3 and 6 months
Title
Psoriasis Knowledge questionnaire
Description
40 questions about psoriasis and psoriasis treatment
Time Frame
change in knowledge from baseline to 3 weeks, 3 months and 6 monthts
Title
Willingness to change to manage psoriasis
Description
8 questions about plans for change or conducted change managing psoriasis symptoms
Time Frame
change from baseline to 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid K. Wahl, PhD
Organizational Affiliation
University of Oslo, Departement of Health and Society,Department of Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Oslo University hospital, Department for clima therapy
City
Oslo
ZIP/Postal Code
0027
Country
Norway
Facility Name
University of Oslo, Departement of health and society
City
Oslo
Country
Norway

12. IPD Sharing Statement

Links:
URL
http://www.med.uio.no/helsam/english/research/projects/psoriasis-climate-therapy/index.html
Description
Related Info

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

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