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Completed

NCT Number: NCT04218721

Implementing eHealth Interventions Into Regular Clinical Practice

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.

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Key information

Conditions

Renal Transplant Recipients Behavior Communication Non-functioning Pituitary Adenoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University hospital

Oslo, 0588, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

InvolveMe

Other

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Health Literacy Questionnaire (HLQ)

    Time frame: 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.

Other outcomes

  1. System Usability Scale (SUS)

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian Nurses Organisation

Registry information

Official study title

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

Acronym: InvolveMe

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 6, 2020
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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