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

12. april 2014 opdateret af: Silvia Riva, University of Lugano

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

50

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants are screened through their healthcare provider at selected clinics and rehabilitation centers in the Canton Ticino (Switzerland).

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
group 1
No intervention
Group 2
Intervention with interactive website
Andet: Internet-based

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Empowerment level (psychological measure)
Tidsramme: 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).
8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medication misuse Physical exercise Pain burden
Tidsramme: 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
8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Lugano

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2013

Primær færdiggørelse (Faktiske)

1. september 2013

Datoer for studieregistrering

Først indsendt

10. april 2014

Først indsendt, der opfyldte QC-kriterier

12. april 2014

Først opslået (Skøn)

15. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FNS100013_130030/1

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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