Implementing eHealth Interventions Into Regular Clinical Practice

Not Applicable

Completed

• Conditions: Renal Transplant Recipients; Non-functioning Pituitary Adenoma

• Registration Number: NCT04218721
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-03
• Study First Posted: 2020-01-06
• Study Start: 2020-04-24
• Primary Completion: 2020-09-28
• Study Completion: 2020-09-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in SF-36 Item Short Form Health Survey (RAND-36 version)	Baseline and 3 months	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.
Change in The Hospital Anxiety and Depression Scale (HADS)	Baseline and 3 months	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

Secondary Outcome Measures

Name	Time	Method
Health Literacy Questionnaire (HLQ)	Baseline and 3 months	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.

Trial Locations

Locations (1)

Oslo University hospital; 🇳🇴 Oslo, Norway