Implementing eHealth Interventions Into Regular Clinical Practice (InvolveMe)

Implementing eHealth Interventions Into Regular Clinical Practice to Enhance Care Planning, Communication and Patient Involvement

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.

Study Overview

• Status: Completed
• Conditions: Renal Transplant Recipients; Non-functioning Pituitary Adenoma
• Intervention / Treatment: Other: InvolveMe

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0588
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eHealth application; Participants get access to the eHealth application InvolveMe	Other: InvolveMe; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Norwegian Nurses Organisation
• Investigators: Principal Investigator: Elin Børøsund, PhD, Oslo University Hospital

Publications and helpful links

General 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.
• 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.

Helpful Links

• Study homepage

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2020
• Primary Completion (Actual): September 28, 2020
• Study Completion (Actual): September 28, 2020

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Implementation; eHealth; Shared decision making; Communication; Symptom assessment
• Additional Relevant MeSH Terms: Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Endocrine Gland Neoplasms; Neoplasms, Glandular and Epithelial; Nervous System Neoplasms; Central Nervous System Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Pituitary Diseases; Adenoma; Pituitary Neoplasms
• Other Study ID Numbers: 2018/201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No