Clinical trial NCT04218721: Implementing eHealth Interventions Into Regular Clinical Practice
Official title: Implementing eHealth Interventions Into Regular Clinical Practice to Enhance Care Planning, Communication and Patient Involvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Transplant Recipients
Non-functioning Pituitary Adenoma
Keywords: Symptom assessment
eHealth
Implementation
Communication
Shared decision making
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Nurses Organisation
First posted: 2020-01-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants get access to the ehealth application
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose with this study is to test a digital patient-provider communication tool for symptom and needs management among patients with chronic health conditions.

Detailed description: 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 is tested in a feasibility pilot study, including 23 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 months.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Change in SF-36 Item Short Form Health Survey (RAND-36 version)
timeFrame: Baseline and 3 months
measure: Change in The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Health Literacy Questionnaire (HLQ)
timeFrame: Baseline and 3 months
Other outcomes:
measure: System Usability Scale (SUS)
timeFrame: 3 months
Locations:
city: Oslo
country: Norway
facility: Oslo University hospital
Study officials:
affiliation: Oslo University Hospital
name: Elin Børøsund, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.