NCT04866550

Brief Summary

Chronic diseases are frequent (around 10% of the total population and 30% after 60 years) and accelerate age-related functional decline. Concerning cross-border patients, use of health services can be delayed given the distances, the lack of rapid road access and the limited availability of public transport and the complex organization of coordinated care. One of the ways to reduce acute exacerbations and preserve the quality of life of patients is to detect warning signs early. One of the ways to do this is to use new communication technologies.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 25, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

May 3, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

April 27, 2021

Last Update Submit

May 2, 2022

Conditions

Keywords

Chronic diseasesAging peopleCross-border careNew communication technology

Outcome Measures

Primary Outcomes (1)

  • Alert according to the connected tablet

    significant change in temperature (egal or more 38°), weight (variation of more than 5%), heart rate (less than 50 beats per minute or greater than 100), systolic blood pressure (less than 85 mmHg or greater than 160 mmHg) and / or oxygen saturation (variation of more than 4%)

    12 months

Study Arms (1)

Connected tablet

Patients aged over 60, living at home, with heart failure and / or chronic obstructive pulmonary disease, potentially requiring care cross-border (France and Belgium).

Other: Data collection

Interventions

Daily record of temperature, weight, heart rate, systolic blood pressure and oxygen saturation

Connected tablet

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged over 60, living at home, with heart failure and / or chronic obstructive pulmonary disease, potentially requiring care cross-border (France and Belgium).

You may qualify if:

  • Patients aged over 60
  • Patients living at home
  • Patients with heart failure and / or chronic obstructive pulmonary disease,
  • Patients potentially requiring care cross-border (France and Belgium).
  • Patients agreeing to participate to the study

You may not qualify if:

  • Patients who do not speak French
  • Patients with severe cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Reims Champagne-Ardenne

Reims, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHeart FailureChronic Disease

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jean-Luc NOVELLA

    Université de Reims Champagne-Ardenne - CHU de Reims

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 29, 2021

Study Start

June 25, 2021

Primary Completion

June 1, 2022

Study Completion

August 1, 2022

Last Updated

May 3, 2022

Record last verified: 2022-05

Locations