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Clinical Trials/NCT02114788
NCT02114788
Completed
Not Applicable

INTERACTIVE SECTIONS OF AN INTERNET-BASED INTERVENTION INCREASE PATIENT EMPOWERMENT: A RANDOMIZED CONTROLLED STUDY WITH CHRONIC BACK PAIN PATIENTS

University of Lugano1 site in 1 country50 target enrollmentMarch 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Group 1 (Control): Access to a Static Version of the Website Containing Only Static Features (i.e. Library, First Aid, and FAQ)
Sponsor
University of Lugano
Enrollment
50
Locations
1
Primary Endpoint
Empowerment level (psychological measure)
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The aim of the study is to study how to improve patients' management of chronic back pain, particularly their management of prescription medication, through increasing health literacy and patient empowerment through an internet based intervention. We do this by designing both patient education materials and physician communication strategies to increase literacy and volitional components of patients. We will test two conditions using a website called Oneself: one providing only information (literacy-only control) and a second providing relational communications designed to increase both literacy and volitional empowerment. To test the self-management enhancing effects of empowerment and health literacy, we will conduct a longitudinal experiment with 51 chronich back pain patients over two months. This span of time is the minimum necessary to achieve a systematic change in self-management and literacy skills, increasing also the range of possible decisions to be made and actions to be real-ized by the patients.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
September 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Lugano
Responsible Party
Principal Investigator
Principal Investigator

Silvia Riva

Dr

University of Lugano

Eligibility Criteria

Inclusion Criteria

  • aged \> 18 years,
  • having suffered from back pain for at least 3 months,
  • no concurrent involvement in other studies.

Exclusion Criteria

  • No access/limited access to computer and internet
  • concurrent diseases

Outcomes

Primary Outcomes

Empowerment level (psychological measure)

Time Frame: 8 weeks

Empowerment is a pychological outcome measure. Patient empowerment is defined as a complex construct that includes different individual competencies and skills. Empowerment can be considered a multilevel and multidimensional construct closely linked to self-determination and self-efficacy. Empowerment is measured the with the Psychological Empowerment Scale According to the scale, empowerment is a multidimensional concept composed of four cognitive dimensions (or task assessments): impact (or the degree to which behavior is seen as "making a difference"), competence (or the degree to which a person can perform task activities skillfully), meaningfulness (or the individual's intrinsic caring about a given task), and choice (or whether a person's behavior is perceived as self-determined).

Secondary Outcomes

  • Medication misuse Physical exercise Pain burden(8 weeks)

Study Sites (1)

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