Implementing eHealth Interventions Into Regular Clinical Practice (InvolveMe)
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|ClinicalTrials.gov Identifier: NCT04218721|
Recruitment Status : Not yet recruiting
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplant Recipients Non-functioning Pituitary Adenoma||Other: InvolveMe||Not Applicable|
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.
|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|
Experimental: eHealth application
Participants get access to the eHealth application 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.
- 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.
- 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
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04218721
|Contact: Berit Seljelid, MSfirstname.lastname@example.org|
|Principal Investigator:||Elin Børøsund, PhD||Oslo University Hospital|