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CompletedNCT04218721InvolveMeUpdated May 31, 2025

Implementing eHealth Interventions Into Regular Clinical Practice

An interventional study of InvolveMe in Renal Transplant Recipients and Non-functioning Pituitary Adenoma, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Transplant Recipients
  • Non-functioning Pituitary Adenoma

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Keywords

  • Symptom assessment
  • eHealth
  • Implementation
  • Communication
  • Shared decision making
03

In context

Communication

198 studies on the registry are indexed under Communication; 85 are open to participants now.

This study's enrollment of 23 is below the median of 161 across 170 interventional studies indexed under Communication.

Browse Communication studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 830 studies on the registry; 146 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • N/A
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    eHealth application

    Participants get access to the eHealth application InvolveMe

    Other: InvolveMe

Interventions

  • OtherInvolveMe

    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.

06

What researchers measure

Primary outcomes

  1. Change in SF-36 Item Short Form Health Survey (RAND-36 version)

    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.

    Time frame: Baseline and 3 months

  2. Change in The Hospital Anxiety and Depression Scale (HADS)

    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 levels of anxiety and depression

    Time frame: Baseline and 3 months

Secondary outcomes

  1. Health Literacy Questionnaire (HLQ)

    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 indicate better health literacy.

    Time frame: Baseline and 3 months

Other outcomes

  1. System Usability Scale (SUS)

    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.

    Time frame: 3 months

07

Study locations

1 site
  • Oslo University hospital
    Oslo, 0588, Norway
08

References and documents

Publications

  • 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. PubMed 35389356 ↗
  • 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. PubMed 32131808 ↗
  • 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. PubMed 33830063 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04218721
Collaborators
Norwegian Nurses Organisation
Responsible party
Elin Børøsund (Head of Research and Education, Oslo University Hospital) — Principal investigator
First posted
Jan 6, 2020
Start date
Apr 24, 2020
Primary completion
Sep 28, 2020
Completion
Sep 28, 2020
Last update
May 31, 2025

Study contacts

Elin Børøsund, PhD
principal investigator · Oslo University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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