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

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

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.

Study Overview

• Status: Completed
• 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
• Intervention / Treatment: Other: Internet-based

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Switzerland
  • Canton Ticino
    • Lugano, Canton Ticino, Switzerland, 6900
      • Insitute of Communication nad Health, University of Lugano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication misuse Physical exercise Pain burden	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	8 weeks

Collaborators and Investigators

• Sponsor: University of Lugano

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 12, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Estimate): April 15, 2014
• Last Update Submitted That Met QC Criteria: April 12, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: FNS100013_130030/1