Implementing eHealth Interventions Into Regular Clinical Practice (InvolveMe)
Implementing eHealth Interventions Into Regular Clinical Practice to Enhance Care Planning, Communication and Patient Involvement
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Living with chronic health conditions affects all areas of life. Fatigue, sleeping problems, pain and loneliness are common. In addition to troublesome symptoms that vary in intensity, many experience worry and uncertainty. There is a need to improve the quality of follow-up of patients with chronic health conditions. A digital patient-provider communication tool, which supports shared decision making, can be one way to improve quality.
The digital tool (InvolveMe) will provide patients with the opportunity to complete and submit a symptom and need assessment prior to out-patient visits at the hospital. Also, patients will have the opportunity to use secure e-mail for follow-up from health care providers in between hospital visits. The assessment will allow patient to prioritize what is important to talk with their health care providers about.
Such a tool can help to make changes in symptoms more visible to both patients and health care providers, as well as make it easier to ask for information and guidance to deal with the individual difficulties patients' experience. The goal is to better address symptoms and concerns and to enhance follow up and coordination between consultations as well as increase the quality of life and reduce illness related stress.
The digital communication tool will first be tested in a feasibility pilot study. The tool will be offered to 50 patients (kidney transplant recipients and patients with non-functioning pituitary adenomas). Participants will be given the opportunity to use the digital communication tool with baseline measures and following measures after 3 and 6 months.
After pilot testing of the tool, a larger longitudinal clinical study among 160 patients with non-functioning pituitary adenomas (n=60) and kidney transplant recipients (n=100) will be conducted to assess the clinical utility. The participants will be assigned to use the digital communication tool, and will be followed with repeated measures over 12 months.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
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Oslo, Norge, 0588
- Oslo University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients with a renal transplant (RTX) OR patients with Non functioning pituitary adenomas (NFPA)
- Able to read and speak Norwegian
- Have access to a Smart-phone or tablet
- Have their own secure access device (BankID).
Exclusion Criteria:
- N/A
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: eHealth application
Participants get access to the eHealth application InvolveMe
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An eHealth application that allows participants to report symptoms and needs prior to out-patient visits at the hospital.
The application creates a summary that allows patients to prioritize what is important to talk with their health care providers about.
Health care providers can use the summary to prepare the consultation.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in SF-36 Item Short Form Health Survey (RAND-36 version)
Tidsram: Baseline, 3, 6, and 12 months
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36 item scale measuring health related quality of life (HRQoL).
The scale has 8 subscales and 1 single item score.
Scale and single item range: 0 to 100.
Higher scores indicate higher HRQoL.
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Baseline, 3, 6, and 12 months
|
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Change in The Hospital Anxiety and Depression Scale (HADS)
Tidsram: Baseline, 3, 6, and 12 months
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14 item scale measuring anxiety and depression.
The Scale has a total score with a scale range of 0 to 42 and an anxiety (HADS-A) and a depression (HADS-D) subscale, both with scale range of 0 to 21.
Higher scores indicate higher level of anxiety and depression
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Baseline, 3, 6, and 12 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Health Literacy Questionnaire (HLQ)
Tidsram: Baseline, 3, 6, and 12 months
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44 item scale measuring health literacy.
The scale consists of 9 subscales that covers distinct areas of health literacy.
The scores for the first 5 scales range from 1 to 4, and the scores for scale 6-9 range from 1 to 5. Higher scores indicates better health literacy.
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Baseline, 3, 6, and 12 months
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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System Usability Scale (SUS)
Tidsram: 3, 6, and 12 months
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10 item scale measuring system usability.
The scale has a total score with a range from 0 to 100.
Higher scores indicate higher system usability.
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3, 6, and 12 months
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Elin Børøsund, PhD, Oslo University Hospital
Publikationer och användbara länkar
Allmänna publikationer
- Seljelid B, Varsi C, Solberg Nes L, Oystese KA, Borosund E. Feasibility of a Digital Patient-Provider Communication Intervention to Support Shared Decision-Making in Chronic Health Care, InvolveMe: Pilot Study. JMIR Form Res. 2022 Apr 7;6(4):e34738. doi: 10.2196/34738.
- Seljelid B, Varsi C, Solberg Nes L, Stenehjem AE, Bollerslev J, Borosund E. Content and system development of a digital patient-provider communication tool to support shared decision making in chronic health care: InvolveMe. BMC Med Inform Decis Mak. 2020 Mar 4;20(1):46. doi: 10.1186/s12911-020-1065-8.
- Seljelid B, Varsi C, Solberg Nes L, Oystese KA, Borosund E. A Digital Patient-Provider Communication Intervention (InvolveMe): Qualitative Study on the Implementation Preparation Based on Identified Facilitators and Barriers. J Med Internet Res. 2021 Apr 8;23(4):e22399. doi: 10.2196/22399.
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Sjukdomar i det endokrina systemet
- Neoplasmer i endokrina körtel
- Hypothalamus sjukdomar
- Hypothalamiska neoplasmer
- Supratentoriella neoplasmer
- Neoplasmer i hjärnan
- Neoplasmer i centrala nervsystemet
- Neoplasmer i nervsystemet
- Hypofyssjukdomar
- Adenom
- Hypofysneoplasmer
Andra studie-ID-nummer
- 2018/201
Plan för individuella deltagardata (IPD)
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