NCT05062018

Brief Summary

The DO-HEALTH trial will be extended into the cohort including the collection on life style factors such as diet, quality of life and physical activity, as well as health-related data on co-morbid conditions as well as a standardized assessment of multiple organ functions, physical, cognitive and mental function using surveys and standardized health assessments.

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
534

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

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

Study Start

First participant enrolled

November 26, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

4.1 years

First QC Date

September 20, 2021

Last Update Submit

December 2, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Incidence of functional decline

    assessed by short physical performance test battery

    24 months

  • Incidence of injurious falls

    assessed by fall questionnaire at each visit

    24 months

  • Incidence of high blood pressure

    Standardized blood pressure assessment in sitting position

    24 months

  • Incidence of cognitive decline

    assessed by Montreal Cognitive Assessment (MoCA)

    24 months

  • Incidence of infections

    assessed by infection questionnaire at each visit

    24 months

Secondary Outcomes (47)

  • Incidence and prevalence of frailty

    24 months

  • Incidence and prevalence of impaired mobility

    24 months

  • Incidence and prevalence of functional dependency

    24 months

  • Incidence and prevalence of anemia or iron deficiency

    24 months

  • Incidence and prevalence of any cardiovascular disease

    24 months

  • +42 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The DO-HEALTH Cohort includes the population of the former DO-HEALTH clinical trial (NCT01745263)

You may qualify if:

  • Former participation in the DO-HEALTH clinical trial study

You may not qualify if:

  • Inability or unwillingness to give written informed consent
  • Medical condition that would make the results of the tests/assessments unreliable and/or would put too much burden to the participant, and/or leads to safety concerns.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre on Aging and Mobility, University of Zurich, City Hospital Zurich

Zurich, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma, urine

Study Officials

  • Heike Bischoff-Ferrari, Prof. Dr. med. DrPH

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med. DrPH

Study Record Dates

First Submitted

September 20, 2021

First Posted

September 30, 2021

Study Start

November 26, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

December 6, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations