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Implementing eHealth Interventions Into Regular Clinical Practice (InvolveMe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04218721
Recruitment Status : Not yet recruiting
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Norwegian Nurses Organisation
Information provided by (Responsible Party):
Elin Børøsund, 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.

Condition or disease Intervention/treatment Phase
Renal Transplant Recipients Non-functioning Pituitary Adenoma Other: InvolveMe Not Applicable

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 will first be tested in a feasibility pilot study. The tool will be offered to 50 patients (kidney transplant recipients and 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 and 6 months.

After pilot testing of the tool, a larger longitudinal clinical study among 160 patients with non-functioning pituitary adenomas (n=60) and kidney transplant recipients (n=100) will be conducted to assess the clinical utility. The participants will be assigned to use the digital communication tool, and will be followed with repeated measures over 12 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All participants get access to the ehealth application
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Implementing eHealth Interventions Into Regular Clinical Practice to Enhance Care Planning, Communication and Patient Involvement
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Change in SF-36 Item Short Form Health Survey (RAND-36 version) [ Time Frame: Baseline, 3, 6, and 12 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, 3, 6, and 12 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 level of anxiety and depression

Secondary Outcome Measures :
  1. Health Literacy Questionnaire (HLQ) [ Time Frame: Baseline, 3, 6, and 12 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 indicates better health literacy.

Other Outcome Measures:
  1. System Usability Scale (SUS) [ Time Frame: 3, 6, and 12 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with a renal transplant (RTX) OR 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04218721

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Contact: Berit Seljelid, MS +4791153252

Sponsors and Collaborators
Oslo University Hospital
Norwegian Nurses Organisation
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Principal Investigator: Elin Børøsund, PhD Oslo University Hospital

Additional Information:
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Responsible Party: Elin Børøsund, Senior researcher, Oslo University Hospital Identifier: NCT04218721    
Other Study ID Numbers: 2018/201
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elin Børøsund, Oslo University Hospital:
Symptom assessment
Shared decision making
Additional relevant MeSH terms:
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Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Brain Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases