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

NCT02114788 | Completed

• 1 other identifier: FNS100013_130030/1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Empowerment level (psychological measure)

  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).

  8 weeks

Secondary Outcomes (1)

• Medication misuse Physical exercise Pain burden

  8 weeks

Study Arms (2)

group 1

No intervention

Group 2

Intervention with interactive website

Other: Internet-based

Interventions

Internet-based OTHER

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lugano: lead

Study Sites (1)

Insitute of Communication nad Health, University of Lugano

Lugano, Canton Ticino, 6900, Switzerland

Location

Related Publications (1)

• Riva S, Camerini AL, Allam A, Schulz PJ. Interactive sections of an Internet-based intervention increase empowerment of chronic back pain patients: randomized controlled trial. J Med Internet Res. 2014 Aug 13;16(8):e180. doi: 10.2196/jmir.3474.

  PMID: 25119374 DERIVED

Related Links

• website used for the study

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 15, 2014
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

CH (1)