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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01352780
First received: May 11, 2011
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Psoriasis
Behavioral: Motivational interviewing
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Psoriasis and Climate Therapy- Effect of Motivational Follow- up Calls on Clinical and Health Economic Parameters

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • SAPASI (+ PASI at T1 and T2) [ Time Frame: Change in SAPASI from baseline, to 3 weeks, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    The self-administered psoriasis area and severity index (SAPASI) is a structured instrument for measuring the severity of psoriasis.

  • HeiQ [ Time Frame: change from baseline to 3 months, 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change in 15D from baseline to 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults (age 16+ years).

  • Questionnaire about lifestyle [ Time Frame: Change in lifestyle parametres from baseline to 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Questions about exercise, diet, stress, lifestyle change

  • BIPQ-2 [ Time Frame: Change from baseline to 3 and 6 months ] [ Designated as safety issue: No ]
    short questionnaire about illness perception

  • Psoriasis Knowledge questionnaire [ Time Frame: change in knowledge from baseline to 3 weeks, 3 months and 6 monthts ] [ Designated as safety issue: No ]
    40 questions about psoriasis and psoriasis treatment

  • Willingness to change to manage psoriasis [ Time Frame: change from baseline to 3 months and 6 months ] [ Designated as safety issue: No ]
    8 questions about plans for change or conducted change managing psoriasis symptoms


Enrollment: 169
Study Start Date: September 2011
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: usual care
Motivational interviewing
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.


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

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352780

Locations
Norway
University of Oslo, Departement of health and society
Oslo, Norway
Oslo University hospital, Department for clima therapy
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Investigators
Study Chair: Astrid K. Wahl, PhD University of Oslo, Departement of Health and Society,Department of Health Sciences
  More Information

Additional Information:
No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01352780     History of Changes
Other Study ID Numbers: OsloUHBHR
Study First Received: May 11, 2011
Last Updated: September 25, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: University of Oslo, Departement of Health and Society

Keywords provided by Oslo University Hospital:
motivational interviewing
psoriasis
self management

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014