Implementing eHealth Interventions Into Regular Clinical Practice (InvolveMe)
Primary Purpose
Renal Transplant Recipients, Non-functioning Pituitary Adenoma
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
InvolveMe
Sponsored by
About this trial
This is an interventional supportive care trial for Renal Transplant Recipients focused on measuring Symptom assessment, eHealth, Implementation, Communication, Shared decision making
Eligibility Criteria
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
Sites / Locations
- Oslo University hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
eHealth application
Arm Description
Participants get access to the eHealth application InvolveMe
Outcomes
Primary Outcome Measures
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.
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 level of anxiety and depression
Secondary Outcome Measures
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 indicates better health literacy.
Full Information
NCT ID
NCT04218721
First Posted
January 3, 2020
Last Updated
October 31, 2022
Sponsor
Oslo University Hospital
Collaborators
Norwegian Nurses Organisation
1. Study Identification
Unique Protocol Identification Number
NCT04218721
Brief Title
Implementing eHealth Interventions Into Regular Clinical Practice
Acronym
InvolveMe
Official Title
Implementing eHealth Interventions Into Regular Clinical Practice to Enhance Care Planning, Communication and Patient Involvement
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 24, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian Nurses Organisation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Transplant Recipients, Non-functioning Pituitary Adenoma
Keywords
Symptom assessment, eHealth, Implementation, Communication, Shared decision making
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants get access to the ehealth application
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eHealth application
Arm Type
Experimental
Arm Description
Participants get access to the eHealth application InvolveMe
Intervention Type
Other
Intervention Name(s)
InvolveMe
Intervention Description
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 Measure Information:
Title
Change in SF-36 Item Short Form Health Survey (RAND-36 version)
Description
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.
Time Frame
Baseline, 3, 6, and 12 months
Title
Change in The Hospital Anxiety and Depression Scale (HADS)
Description
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
Time Frame
Baseline, 3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Health Literacy Questionnaire (HLQ)
Description
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.
Time Frame
Baseline, 3, 6, and 12 months
Other Pre-specified Outcome Measures:
Title
System Usability Scale (SUS)
Description
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.
Time Frame
3, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elin Børøsund, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University hospital
City
Oslo
ZIP/Postal Code
0588
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35389356
Citation
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.
Results Reference
background
PubMed Identifier
32131808
Citation
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.
Results Reference
background
PubMed Identifier
33830063
Citation
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.
Results Reference
background
Links:
URL
http://involveme.no
Description
Study homepage
Learn more about this trial
Implementing eHealth Interventions Into Regular Clinical Practice
We'll reach out to this number within 24 hrs