Table 1 Administrative information on the NOCfao study
Section/item | ItemNo | Description |
|---|---|---|
Primary Registry and Trial Identifying Number | 1 | ClinicalTrials.gov identifier: NCT02995317 |
Date of Registration in Primary Registry | 2 | December 13th, 2016 |
Secondary Identifying Numbers | 3 | The North Denmark Region Committee on Health Research Ethics (N-20160020) The Danish Data Protection Agency (FOU-UU-006) |
Source(s) of Monetary or Material Support | 4 | The study is externally supported by the Trygfonden Foundation (ID: 119365) |
Primary Sponsor | 5 | University College of Northern Denmark, Denmark |
Secondary Sponsor(s) | 6 | Aalborg University, Denmark Aalborg Municipality, Denmark |
Contact for Public Queries | 7 | Master of Rehabilitation, Bo Grarup; address: Selma Lagerløfs Vej 2, 9220, Aalborg East, Denmark; tel.: 0045 72,690,953; e-mail: bog@ucn.dk |
Contact for Scientific Queries | 8 | Master of Rehabilitation, Bo Grarup; address: Selma Lagerløfs Vej 2, 9220, Aalborg East, Denmark; tel.: 0045 72,690,953; e-mail: bog@ucn.dk |
Public Title | 9 | Who is Falling? – Fall Risk Prediction Among Community-Dwelling Elderly (NOCfao) |
Scientific Title | 10 | The ≥65 Years NOrthern jutland Cohort of Fall risk Assessment with Objective measurements (the NOCfao study) |
Countries of Recruitment | 11 | Denmark |
Health Condition(s) or Problem(s) Studied | 12 | Incidence of falls |
Intervention(s) | 13 | Not applicable |
Key Inclusion and Exclusion Criteria | 14 | Inclusion criteria: home-dwelling, manage body transfer independently, walking ability for at least 10 m with or without assistive devices. Exclusion criteria: progressive neurological or rheumatologically illness, diagnosed vestibular problems, experienced pain in a substantial degree limiting or obstructing everyday living, known uncorrected visual or hearing problems, serious difficulties in speaking, understanding or reading Danish, or cognitive impairment equivalent to Mini Mental State Examination < 23 |
Study Type | 15 | Prospective, observational cohort study |
Date of First Enrollment | 16 | December 2016 |
Target Sample Size | 17 | 600 |
Recruitment Status | 18 | Recruiting: participants are currently being recruited and enrolled |
Primary Outcome(s) | 19 | Self-reported number of falls confirmed by monthly phone calls [Time Frame: One year follow-up] |
Key Secondary Outcomes | 20 | History of fall incidences within the past year; differences between objective measures and self-reported level of PA |