NCT04218721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 24, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2020

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

January 3, 2020

Last Update Submit

May 27, 2025

Conditions

Keywords

Symptom assessmenteHealthImplementationCommunicationShared decision making

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline and 3 months

  • 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

    Baseline and 3 months

Secondary Outcomes (1)

  • Health Literacy Questionnaire (HLQ)

    Baseline and 3 months

Other Outcomes (1)

  • System Usability Scale (SUS)

    3 months

Study Arms (1)

eHealth application

EXPERIMENTAL

Participants get access to the eHealth application InvolveMe

Other: InvolveMe

Interventions

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.

eHealth application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University hospital

Oslo, 0588, Norway

Location

Related Publications (3)

  • 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.

    PMID: 35389356BACKGROUND
  • 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.

    PMID: 32131808BACKGROUND
  • 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.

    PMID: 33830063BACKGROUND

Related Links

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Elin Børøsund, PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: All participants get access to the ehealth application
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research and Education

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 6, 2020

Study Start

April 24, 2020

Primary Completion

September 28, 2020

Study Completion

September 28, 2020

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations