Group 1 (Control): Access to a Static Version of the Website Containing Only Static Features (i.e. Library, First Aid, and FAQ)NCT02114788
Interactive Sections Of An Internet-Based Intervention Increase Patient Empowerment: A Study With Chronic Back Pain Patients
An observational study of Group 1 (Control): Access to a Static Version of the Website Containing Only Static Features (i.e. Library, First Aid, and FAQ) and Group2 (Intervention) Access to an Interactive Version of the Website Containing Both Static and Interactive Features, run by University of Lugano at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- What is being tested?
- Internet-based
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2013to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are screened through their healthcare provider at selected clinics and rehabilitation centers in the Canton Ticino (Switzerland).
Who may be able to join
- aged > 18 years,
- having suffered from back pain for at least 3 months,
- no concurrent involvement in other studies.
Who cannot join
- No access/limited access to computer and internet
- concurrent diseases
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Insitute of Communication nad Health, University of Lugano
Lugano, Canton Ticino, 6900
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-basedOther
| Study group | Role | What they receive |
|---|---|---|
| group 1 | No intervention | |
| Group 2 | Intervention with interactive website Receives: Other: Internet-based |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Secondary outcomes (1)
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startMar 2013
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Group 1 (Control): Access to a Static Version of the Website Containing Only Static Features (i.e. Library, First Aid, and FAQ)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lugano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Riva, University of Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114788
- Sponsor's protocol ID
- FNS100013_130030/1
- Status last verified
- Apr 2014
- First submitted
- 10 Apr 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
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.
PubMed 25119374
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTERACTIVE SECTIONS OF AN INTERNET-BASED INTERVENTION INCREASE PATIENT EMPOWERMENT: A RANDOMIZED CONTROLLED STUDY WITH CHRONIC BACK PAIN PATIENTS
- ClinicalTrials.gov ID
- NCT02114788
- Acronym / sponsor ID
- FNS100013_130030/1
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of LuganoUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –No intervention |
| Group 2 | – | Other: Internet-basedIntervention with interactive website |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are screened through their healthcare provider at selected clinics and rehabilitation centers in the Canton Ticino (Switzerland).
Key inclusion criteria (3 listed)
- aged > 18 years,
- having suffered from back pain for at least 3 months,
- no concurrent involvement in other studies.
Key exclusion criteria (2 listed)
- No access/limited access to computer and internet
- concurrent diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based | Other | Group 2 |
Primary outcome
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).
1 secondary outcome
Medication misuse Physical exercise Pain burden
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Derived from this study: PubMed 25119374Riva 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group 1 (Control): Access to a Static Version of the Website Containing Only Static Features (i.e. Library, First Aid, and FAQ) and Group2 (Intervention) Access to an Interactive Version of the Website Containing Both Static and Interactive Features, run by University of Lugano at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Empowerment level (psychological measure) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02114788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2014.