NCT02825732

Brief Summary

The investigators will investigate which patients' characteristics are associated with caregivers burden and its evolution for outpatients visiting a memory clinic, in particular how functional autonomy, behavioral and psychological symptoms as well as patients comorbidities can influence caregiver burden. The study will be conducted among outpatients with progressive cognitive complaint followed in a Memory Clinic and their primary caregiver. The investigators hypothesis that caregivers experience a higher burden due to disease symptoms such as impairment of functional autonomy, behavioral and cognitive impairment, whatever the aetiology of the cognitive decline.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

3.1 years

First QC Date

July 4, 2016

Last Update Submit

July 7, 2016

Conditions

Neurocognitive Disorders

Keywords

Alzheimer's disease or related disorderComorbidityCharlson comorbidity indexCaregiver burdenCohortDementiaBehavioral disordersFunctional dependency

Outcome Measures

Primary Outcomes (1)

  • Evolution of caregiver burden

    The caregiver burden change will be assessed using two repeated measures of the validated short version of the ZBI.

    Two measured of the caregiver burden at baseline and at follow-up during current care, at 6 months to 12 months of follow-up.

Secondary Outcomes (1)

  • Caregiver burden

    The caregiver burden will be measured at baseline (Day 0)

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes a sample of consecutive dyads of patient-caregiver consulting a neurologist or a geriatrician for a cognitive complaint between November 2011 and December 2014 at the Memory Clinic of the Hospital Charpennes, Villeurbanne, France.

You may qualify if:

  • patients with a cognitive complaint, either expressed by the patient or one of their relatives,
  • patients at any stage of disease (cognitive complaint, mild cognitive impairment (MCI) or dementia),
  • patients living in the community,
  • patients having an informal caregiver who will complete the questionnaire to assess the caregiver burden.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Research Memory Centre of Lyon (CMRR); Geriatrics Unit, Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France - Clinical Research Centre (CRC) - VCF (Aging - Brain - Frailty), Charpennes Hospital, University Hospital of Lyon

Villeurbanne, 69100, France

Location

Related Publications (1)

  • Dauphinot V, Ravier A, Novais T, Delphin-Combe F, Mouchoux C, Krolak-Salmon P. Risk Factors of Caregiver Burden Evolution, for Patients With Subjective Cognitive Decline or Neurocognitive Disorders: A Longitudinal Analysis. J Am Med Dir Assoc. 2016 Nov 1;17(11):1037-1043. doi: 10.1016/j.jamda.2016.07.003. Epub 2016 Aug 26.

    PMID: 27575984DERIVED

MeSH Terms

Conditions

Neurocognitive DisordersAlzheimer DiseaseCaregiver BurdenDementiaMental Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Pierre Krolak-Salmon, Pr

    Clinical and Research Memory Centre of Lyon (CMRR); Geriatrics Unit, Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France - Clinical Research Centre (CRC) - VCF (Aging - Brain - Frailty), Charpennes Hospital, University Hospital of Lyon

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 7, 2016

Study Start

November 1, 2011

Primary Completion

December 1, 2014

Study Completion

January 1, 2016

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

FR(1)