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The Norwegian "iCanCope With Pain" App

4. november 2022 oppdatert av: Erik Grasaas, University of Agder

Cultural Adaptation and Evaluation of the "iCanCope With Pain" App Among Norwegian Adolescents Living With Pain

Background: Research evidence shows that prevalence of pain in adolescents is increasing and is therefore recognized as a growing health problem. Psychological interventions delivered remotely through the internet may reduce intensity or severity of pain among children and adolescents with chronic pain. The iCanCope with Pain program is an existing web- and mobile-based self-management program, which is developed as a multi-center study funded by the Canadian Institutes of Health Research and is based on identified health care needs and current best practices for pain self-management.

Objectives: The primary objectives are to describe the translation and cultural adaptation of the Norwegian version of the iCanCope with Pain mobile application and evaluate the effect in an upcoming randomized controlled trail with adolescents with chronic pain.

Study sample: 16-19-year-old adolescents with self-declared persistent and/or chronic pain. Recruited from high schools in Southern Norway.

Theoretical framework: Cognitive behavioral therapy (CBT) is explained by an integration of behavioral and cognitive theories of human behavior and psychopathology and is often the preferred treatment of choice for adolescents with different health disorders. The theoretical framework of CBT is integrated in the iCanCope with Pain app in terms of five components. The intervention group will receive the app with all five components: (I) symptom trackers for pain, sleep, mood, physical, and social function; (II) goal setting to improve pain and function; (III) coping toolbox of pain self-management strategies; (IV) social support; (V) age-appropriate pain education. The control group will receive the app with only the first self-registration component (I) symptom trackers for pain, sleep, mood, physical, and social function.

Methods: Both qualitative and quantitative data will be gathered for evaluating the Norwegian version of the iCanCope with Pain app. Usability testing are assessed in both laboratory settings and in field using observation, interviews and questionnaires, which provide necessary information for an upcoming randomized controlled trail (RCT). Outcomes will in the RCT be measured at baseline (mid-April) and after an 8 weeks intervention (mid-June).

The study is part of a PhD project.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

112

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Norge
      • Kristiansand, Norge, 4633
        • Erik Grasaas

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

16 år til 19 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. 16-19-year-old adolescents
  2. with persistent and/or chronic pain, weekly suffered and lasting 3 months or more based on subjective reporting
  3. be able to read and understand Norwegian
  4. have their own smartphone.

Exclusion Criteria:

  1. Adolescents with cognitive disability or diseases, because of the risk of not correctly understanding the iCanCope with Pain program via self-report, goal setting and/or library reading.
  2. Adolescents that have participated in the usability testing of the Norwegian iCanCope with Pain app
  3. Adolescents with diagnoses from a pathological or medical origin (e.g hematology/oncology patients) will also be excluded because the program was not specifically designed for these pain groups.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention group
The intervention group will receive the iCanCope with Pain app with all five components: (I) symptom trackers for pain, sleep, mood, physical, and social function; (II) goal setting to improve pain and function; (III) coping toolbox of pain self-management strategies; (IV) social support; (V) age-appropriate pain education
Atferdsmessig: iCanCope with Pain
The participants are free to use the Norwegian iCanCope with Pain app as much as they want during the 8 week intervention period. The only support available is technical support.
Aktiv komparator: Control group
The control group will receive the iCanCope with Pain control app with only the first self-registration component (I) symptom trackers for pain, sleep, mood, physical, and social function.
Atferdsmessig: iCanCope with Pain control
The participants are free to use the Norwegian iCanCope with Pain control app as much as they want during the 8 week intervention period. The only support available is technical support.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Attrition rate
Tidsramme: Baseline and 8-weeks
Change in participants completed the post-questionnaire divided by the number of participants at baseline.
Baseline and 8-weeks
App engagement
Tidsramme: Baseline to 8 weeks.
Completion of daily symptom check-ins was used as a proxy for app engagement.
Baseline to 8 weeks.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physical activity
Tidsramme: Baseline and 8 weeks (post-intervention)
Change in total score of the International Physical Activity Questionnaire (IPAQ). Higher values at post-intervention represent a better outcome.
Baseline and 8 weeks (post-intervention)
Coping
Tidsramme: Baseline and 8 weeks (post-intervention)
Change in total score of the General Self-Efficacy Questionnaire Short Version (GSEQ). Higher values at post-intervention represent a better outcome.
Baseline and 8 weeks (post-intervention)
Social participation
Tidsramme: Baseline and 8 weeks (post-intervention)
Change in total score of school absence (General Information Questionnaire). Lower values at post-intervention represent a better outcome.
Baseline and 8 weeks (post-intervention)
Over-The-Counter (OTC) analgesics
Tidsramme: Baseline and 8 weeks (post-intervention)
Change in total score of OTC analgesics consumption (General Information Questionnaire). Lower values at post-intervention represent a better outcome.
Baseline and 8 weeks (post-intervention)
Perceived social support from friends
Tidsramme: Baseline and 8 weeks (post-intervention)
Change in total score of the Perceived Social Support from friends Questionnaire (PSS). Higher values at post-intervention represent a better outcome.
Baseline and 8 weeks (post-intervention)
Pain self-efficacy questionnaire
Tidsramme: Baseline and 8 weeks (post-intervention)
Change in total score of the Pain Self-Efficacy Questionnaire (PSEQ). Higher values at post-intervention represent a better outcome.
Baseline and 8 weeks (post-intervention)
Anxiety and depression
Tidsramme: Baseline and 8 weeks (post-intervention)
Change in total score of the Hospital Anxiety and Depression Scale Questionnaire (HADS). Lower values at post-intervention represent a better outcome.
Baseline and 8 weeks (post-intervention)
Global impression of change
Tidsramme: After 8 weeks (post-intervention)
Change in Patients' Global Impression of Change Scale (PGIC) from 1-7. Higher values at post-intervention represent a better outcome.
After 8 weeks (post-intervention)
Health-related quality of life (HRQOL)
Tidsramme: Baseline and 8 weeks (post-intervention)
Change in total score of the Kidscreen 52 Questionnaire. Higher values at post-intervention represent a better outcome.
Baseline and 8 weeks (post-intervention)
Pain experience
Tidsramme: Baseline and 8 weeks (post-intervention)
Change in total score of the Lubeck Pain Questionnaire (LPQ). Lower values at post-intervention represent a better outcome.
Baseline and 8 weeks (post-intervention)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Agder

Samarbeidspartnere

The Hospital for Sick Children

Etterforskere

  • Hovedetterforsker: Kristin Haraldstad, PhD, UiA

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. november 2017

Primær fullføring (Faktiske)

15. juni 2018

Studiet fullført (Faktiske)

15. juni 2018

Datoer for studieregistrering

Først innsendt

15. mai 2018

Først innsendt som oppfylte QC-kriteriene

28. mai 2018

Først lagt ut (Faktiske)

11. juni 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. november 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2022

Sist bekreftet

1. november 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 1310 63221

Plan for individuelle deltakerdata (IPD)

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NEI

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Nei

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