Research with human participants

Overview of medical research in the Netherlands

Lifestyle Self-Monitoring of Individualized Multiple Risk Factor Management towards Disease Modification of Dementia and other Age-related Diseases ;Pilot Study: DEVELOPMENT OF A PERSONALIZED MULTI COMPONENT LIFESTYLE INTERVENTION AND TESTING OF THE BAM-COG TOOL AGAINST COGNITIVE DECLINE.

Published:
Last updated:

Zie onderzoeksprotocol.

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Other condition
Study type
Interventional research previously applied in human subjects

ID

NL-OMON57059

Source

ToetsingOnline

Brief title

Lifestyle Selfie Study: Pilot

Condition

  • Other condition

Synonym

alzheimers' disease cognitive decline dementia

Research involving

Human

Sponsors and support

Primary sponsor :
Radboud Universitair Medisch Centrum
Source(s) of monetary or material Support :
Health Holland, SGF & ZonMW

Intervention

  • Life style intervention
Keyword :
Bio-marker, Cognitive decline, Lifestyle, Self-monitoring
Explanation

N.a.

Outcome measures

Primary outcome

<p>Zie onderzoeksprotocol.</p>

Secondary outcome

<p>Zie onderzoeksprotocol.</p>

Background summary

Zie onderzoeksprotocol.

Study objective

Zie onderzoeksprotocol.

Study design

Zie onderzoeksprotocol.

Intervention

Zie onderzoeksprotocol.

Study burden and risks

Zie onderzoeksprotocol.

Scientific
Radboud Universitair Medisch Centrum
C.J.T. Schoenaker
Geert Groteplein Zuid 10
Nijmegen 6500HB
Netherlands
0627746143
colin.schoenaker@radboudumc.nl
Public
Radboud Universitair Medisch Centrum
C.J.T. Schoenaker
Geert Groteplein Zuid 10
Nijmegen 6500HB
Netherlands
0627746143
colin.schoenaker@radboudumc.nl

Trial sites in the Netherlands

Radboud Universitair Medisch Centrum
Target size :
100

Listed location countries

Netherlands

Age

Elderly (65 years and older)

Inclusion criteria

Inclusion criteria are: subjective memory complaints, the ability to operate a 
smartphone, and basic Dutch language proficiency. These criteria will primarily 
target individuals aged 65+.

Exclusion criteria

Life expectancy of <12 months, Familial dementia (Alzheimers Disease),
inability to communicate with researchers due to visual, verbal or motor
impairments.

Design

Study phase :
N/A
Study type :
Interventional research previously applied in human subjects
Intervention model
:
Single
Allocation :
Non controlled trial
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Prevention

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
50
Duration
:
6 months (per patient)
Type :
Actual

Medical products/devices used

Product type :
N.a.
Registration
:
No

IPD sharing statement

Plan to share IPD :
Yes

Plan description

Zie onderzoeksprotocol & DMP, enkele beperkingen i.v.m. samenwerking bedrijven.

Approved WMO
Date :
Application type :
First submission
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Oost-Nederland

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL87040.091.24
Research portal NL-005431