Explorative Study on a New Device' Ability to Register Hydration Change in Elderly Subjects During Rehabilitation.

CTR025 FAUN - Hydration Status

Test the ability of continuous measurements from a new sensor patch to set the hydration state in subjects who are malnourished/dehydrated or overhydrated or otherwise not optimally hydrated. Specifically, clinical examination, blood pressure, blood tests, and weight change at the admission and at the discharge will be used to establish the true hydration status of the subjects.

Study Overview

• Status: Withdrawn
• Conditions: Dehydrated, Water-Electrolyte Imbalance, Malnutrition
• Intervention / Treatment: Other: No intervention done

• Study Type: Observational

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0569
    • Lilleborg helsehus
  • Oslo, Norway, 0580
    • Ryen helsehus
  • Oslo, Norway, 0664
    • Solvang helsehus
  • Trondheim, Norway, 7030
    • Øya helsehus
  • Trondheim, Norway, 7037
    • Nidarvoll helsehus
  • Trondheim, Norway, 7078
    • Søbstad helsehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Elderly people eligible for short term (3 - 5 weeks) rehabilitation because of either (i) malnutrition and or dehydration, or (ii) overhydration from heart failure treatment.

Description

Inclusion Criteria:

• Elderly patients eligible for rehabilitation

Exclusion Criteria:

• Subjects with end stage cancer

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elderly; Elderly (> 70 yrs) eligible for a short term rehabilitation	Other: No intervention done; No intervention was done. This was an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hydration state	Set correct hydration state with a sensitivity of 0.90 and a specificity of 0.80	During rehabilitation period (3 - 5 weeks)

Collaborators and Investigators

• Sponsor: Mode Sensors AS
• Collaborators: Norwegian Computing Center, Oslo Norway; Lilleborg helsehus, Oslo, Norway; Nidarvoll helsehus, Trondheim, Norway; Ryen helsehus, Trondheim, Norway; Solvang helsehus, Oslo, Norway; Søbstad helsehus, Trondheim, Norway; Øya helsehus, Trondheim, Norway

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Malnutrition; Water-Electrolyte Imbalance
• Other Study ID Numbers: CTR002 FAUN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No