Implementing eHealth Interventions Into Regular Clinical Practice (InvolveMe)
Implementing eHealth Interventions Into Regular Clinical Practice to Enhance Care Planning, Communication and Patient Involvement
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Oslo, Noorwegen, 0588
- Oslo University Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in SF-36 Item Short Form Health Survey (RAND-36 version)
Tijdsspanne: 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)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Health Literacy Questionnaire (HLQ)
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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System Usability Scale (SUS)
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Elin Børøsund, PhD, Oslo University Hospital
Publicaties en nuttige links
Algemene publicaties
- 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.
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Neoplasmata, glandulair en epitheel
- Endocriene systeemziekten
- Endocriene klierneoplasmata
- Hypothalamische ziekten
- Hypothalamische neoplasmata
- Supratentoriale neoplasmata
- Hersenneoplasmata
- Neoplasmata van het centrale zenuwstelsel
- Neoplasmata van het zenuwstelsel
- Hypofyse Ziekten
- Adenoom
- Hypofyse-neoplasmata
Andere studie-ID-nummers
- 2018/201
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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