Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation

Not Applicable

Not yet recruiting

• Conditions: Heart Failure

• Registration Number: NCT06126848
• Lead Sponsor: Nisha Arenja

Brief Summary

Digital biomarkers extracted by ambient sensor signals are a promising tool for early detection of health deterioration in the setting of remote patient management of heart failure patients.The primary objective of the study is to evaluate new digital biomarkers as predictors of impending heart failure decompensation.

Secondary objectives are (1) outcome assessment (re-hospitalizations, cardiovascular death, all-cause death), (2) quality of life and (3) System User Satisfaction (SUS)

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-06
• Last Update Submitted: 2023-11-10
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-14
• Study Start: 2024-01
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• admitted to hospital for worsening HF
• age ≥ 70 years
• LVEF < 50% and need of diuretics
• NYHA II or III
• living alone
• willing to participate with informed consent.

Exclusion Criteria

• Major depression (PHQ 9-score >9)
• being on hemodialysis
• had been admitted to hospital for any reason within 7 days before HF decompensation.
• patients with a left ventricular assist device
• coronary revascularization or cardiac resynchronization therapy implantation within 28 days before the index event of HF decompensation or have been scheduled for such interventions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of ambient sensor derived digital biomarkers	6 months	Sensitivity and specificity of a combination of ambient sensor derived digital biomarker for the prediction of brain natriuretic peptide (BNP) increase of ≥ 20% compared to baseline value.

Secondary Outcome Measures

Name	Time	Method
Quality of life (heart failure symptoms) - KCCQ	6 months	KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Outcome assessment	6 months	re-hospitalizations, cardiovascular death, all-cause death
System Usability Scale (SUS)	6 months	SUS score 0-100; 80.3 or higher is an A. People will recommend it to their friends 68 or there abouts gets you a C. You are doing OK but could improve 51 or under gets you a big fat F. Make usability your priority now and fix this fast.