NCT03994237

Brief Summary

Initiatives have been taken hotline in France and abroad for other conditions, they provide support to patients and their caregivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 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

December 12, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2019

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
Last Updated

July 1, 2019

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

May 21, 2019

Last Update Submit

June 26, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • score of the grid "MiniZarit"

    The evaluation of the quality of life of the caregiver, score between 0 and 7. point for positive response for difficulties in family life, difficulties in relationships with friends, hobbies, or in your job, a repercussion on health (physical and / or psychological), feeling that caregiver is no longer recognizing his parent, he afraid for the future of his parent, he would like to be (more) helped to take care of his parent, he feel a burden in taking care of his parent.

    Month 1

  • score of the EuroQuol scale

    The evaluation of the quality of life of the caregiver The point repartition : Mobility (1 point : to have no problem getting around on foot ; 2 : to have problems getting around on foot; 3. to oblige to remain in bed) Self-sufficiency (1 point : to have no problem taking care of myself; 2 : to have problems washing or dressing myself alone;3 : to be unable to wash or dress myself alone) Regular activities (1 point : to have no problem performing my daily activities (eg work, study, housework, family activities or hobbies) ;2. : to have problems to perform my day-to-day activities;3. : to be unable to perform my normal activities.) Pain / discomfort (1. : to have no pain or discomfort; 2. : to have moderate pain or discomfort (s), 3. : to have severe pain or discomfort (s)) Anxiety / Depression (1. : to be not anxious or depressed; 2. : to be moderately anxious or depressed ;3. : to be extremely anxious or depressed)

    Month 1

Secondary Outcomes (3)

  • Number of days between pre-clinical consultation and consultation MEMORY

    Month 3

  • Questionnary for caregivers' organization

    Day 1

  • Questionnary for caregivers' organization

    Month 1

Study Arms (1)

ALZHEIMER CAREGIVER

Caregiver available to accompany the patient to the consultation, helping calling for the first time the memory center, aidant who noticed a cognitive disorder help, having a family link identified with the patient

Other: semi-structured interview

Interventions

The tool used is a nurse card: there is no validated tool on the expectations of the caregiver in his memory referral. This is a pragmatic and practical questionnaire memory consultation request and domestic life with few items, practical use by telephone.

ALZHEIMER CAREGIVER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Helping with age ≥ 18 years, speaking and understanding the French and available to accompany the patient to the consultation

You may qualify if:

  • Helping with age ≥ 18 years
  • Helping speak and understand the French
  • Help available to accompany the patient to the consultation
  • Helping calling for the first time the memory center
  • Helping who noticed a cognitive disorder in assisted
  • Age over 75 years
  • beneficiary or affiliated to a social security scheme Patient
  • Patient with a cognitive disorder noticed by the caregiver

You may not qualify if:

  • Helping placed under judicial protection
  • Any medical or paramedical personnel in connection with the care of a nursing home eligible patient (Accommodation Establishment for dependent elderly, hospital, SSR (Care and Rehabilitation Services), institutional caregivers,
  • private health professionals, such as neighborhood (doctor, nurse liberal, physiotherapist
  • Neighborhood.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Pessac, 33600, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Isabelle GUILLARD

    University of Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 21, 2019

First Posted

June 21, 2019

Study Start

December 12, 2018

Primary Completion

June 7, 2019

Study Completion

June 7, 2019

Last Updated

July 1, 2019

Record last verified: 2019-05

Locations