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Interactive Sections Of An Internet-Based Intervention Increase Patient Empowerment: A Study With Chronic Back Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02114788
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
Information provided by (Responsible Party):
Silvia Riva, University of Lugano

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.

Condition or disease Intervention/treatment
Group 1 (Control): Access to a Static Version of the Website Containing Only Static Features (i.e. Library, First Aid, and FAQ) Group2 (Intervention) Access to an Interactive Version of the Website Containing Both Static and Interactive Features Other: Internet-based

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2013
Actual Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort Intervention/treatment
group 1
No intervention
Group 2
Intervention with interactive website
Other: Internet-based

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Medication misuse Physical exercise Pain burden [ Time Frame: 8 weeks ]

    Medication misuse is measured with the Prescription Medication Use and Perception of Risk Instrument. The scale is scored as a continuous measure to provide greater sensitivity ranging from 0 (strongly disagree) to 6 (strongly agree) with higher scores indicating greater level of medication misuse.

    Physical exercise in leisure time is measured with the respective sub-dimensions from the Short Questionnaire to Assess Health-Enhancing Physical Activity and it gives the amount of time spent in physical exercise in hours/week

    Pain burden is measured with six items from the Chronic Pain Grading Scale that gives two measures related with pain: pain disability perception and pain intensity perception

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants are screened through their healthcare provider at selected clinics and rehabilitation centers in the Canton Ticino (Switzerland).

Inclusion Criteria:

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

Exclusion Criteria:

  1. No access/limited access to computer and internet
  2. concurrent diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02114788

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Insitute of Communication nad Health, University of Lugano
Lugano, Canton Ticino, Switzerland, 6900
Sponsors and Collaborators
University of Lugano
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Silvia Riva, Dr, University of Lugano Identifier: NCT02114788    
Other Study ID Numbers: FNS100013_130030/1
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Back Pain
Neurologic Manifestations
Signs and Symptoms