Implementing eHealth Interventions Into Regular Clinical Practice

Renal Transplant Recipients Clinical Trial

— InvolveMe  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04218721
• Other study ID #: 2018/201
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 24, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Non-functioning Pituitary Adenoma
• Pituitary Neoplasms
• Renal Transplant Recipients

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Nurses Organisation

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Seljelid B, Varsi C, Solberg Nes L, Øystese KA, Børøsund 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. — View Citation

Seljelid B, Varsi C, Solberg Nes L, Øystese KA, Børøsund 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. — View Citation

Seljelid B, Varsi C, Solberg Nes L, Stenehjem AE, Bollerslev J, Børøsund 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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, 6, and 12 months
Primary	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, 3, 6, and 12 months
Primary	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	Baseline, 3, 6, and 12 months
Secondary	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.	Baseline, 3, 6, and 12 months

External Links

•   Study homepage