Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325384
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-01-24
Brief Title:
Real World Evaluation of Lifelight A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care
Sponsor:
Xim Limited
Organization:
Xim Limited
Study Overview
Official Title:
VISION-Real World Evaluation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VISION-RWE
Brief Summary:
A randomised controlled trial for comparison of real-world feasibility and clinical outcomes of two different methods of home blood pressure monitoring Participants aged 18 years or over with diagnosed and treated hypertension including via lifestyle interventions that is not controlled ie in-clinic measurement is 14090 mmHg or greater will be recruited from hypertension hospital clinics
Detailed Description:
Suitable patients from the BHT hypertension clinic patient database will be invited to take part in the study resulting in the recruitment of 500 people aged 18 years or over who have a clinical diagnosis of hypertension that is treated including via lifestyle interventions but not controlled 14090mmHg in-clinic measurement of BP Study nurses at BHT will facilitate this recruitment and randomise participants to either Lifelight or BP cuff arm using a secure web-based system in 11 ratio minimised on baseline BP gender and BP target standard hypertension older hypertension and diabetes They will also collect all baseline study data including baseline BP measurements
The HBPM schedule that all participants will be asked to follow for the full 6-month study duration is HBPM using BP cuff or Lifelight depending on into which arm of the study they have been randomised twice in a sitting for two sittings a day for one week every month All participants will be asked to record their adherence to HBPM in the provided diary recording the number of repeat measurements made on each day that those measurements are made and notes about any measurement failures They will also be requested to record in their diary information about their healthcare resource use GP appointments outpatients appointments hospitalisations medication and dose changes medication adherence and feedback about their HBPM method every month All participants will also be asked to complete a set of tailored and validated questionnaires in the provided questionnaire booklet quality of life
The diaries and questionnaire booklets include instructions to assist with their accurate completion by participants Participants will be issued with two diaries during their study participation one at the baseline visit and one at the 3-month visit They should complete the diary every day that they are doing HBPM Participants will be issued with 3 questionnaire booklets during their study participation two at the baseline visit and one at the 3-month visit They should complete one questionnaire booklet within one week of their baseline visit the second booklet within one week of their 3-month visit and the third booklet within one week of their 6-month visit Participants will be requested to bring back the diary and questionnaire booklets at their subsequent study visit at BHT Participants randomised to the Lifelight arm will be prompted via the app to monitor their BP during the relevant weeks
People eligible to take part in this study will be adults 18 years old with treated but uncontrolled hypertension People with uncontrolled hypertension have the highest risk of CVD events and therefore the value of HBPM could be greatest for these people The TASMIN and HOME BP studies focussed on this sub-population of patients with hypertension too suggesting that future guidelines may continue to provide no recommendation of frequent HBPM for people with controlled hypertension but a change to the guidelines for people with uncontrolled hypertension
The HBPM schedule that all participants will be asked to follow for the full 6-month study duration is HBPM using BP cuff or Lifelight depending on into which arm of the study they have been randomised twice in a sitting for two sittings a day for one week every month All participants will be asked to record their adherence to HBPM in the provided diary recording the number of repeat measurements made on each day that those measurements are made and notes about any measurement failures They will also be requested to record in their diary information about their healthcare resource use GP appointments outpatients appointments hospitalisations medication and dose changes medication adherence and feedback about their HBPM method every month All participants will also be asked to complete a set of tailored and validated questionnaires in the provided questionnaire booklet quality of life
The diaries and questionnaire booklets include instructions to assist with their accurate completion by participants Participants will be issued with two diaries during their study participation one at the baseline visit and one at the 3-month visit They should complete the diary every day that they are doing HBPM Participants will be issued with 3 questionnaire booklets during their study participation two at the baseline visit and one at the 3-month visit They should complete one questionnaire booklet within one week of their baseline visit the second booklet within one week of their 3-month visit and the third booklet within one week of their 6-month visit Participants will be requested to bring back the diary and questionnaire booklets at their subsequent study visit at BHT Participants randomised to the Lifelight arm will be prompted via the app to monitor their BP during the relevant weeks
People eligible to take part in this study will be adults 18 years old with treated but uncontrolled hypertension People with uncontrolled hypertension have the highest risk of CVD events and therefore the value of HBPM could be greatest for these people The TASMIN and HOME BP studies focussed on this sub-population of patients with hypertension too suggesting that future guidelines may continue to provide no recommendation of frequent HBPM for people with controlled hypertension but a change to the guidelines for people with uncontrolled hypertension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None