Meaningful Aspects of Health for Adults With Dementia, Their Care Partners and Healthcare Practitioners (DiME)

March 19, 2024 updated by: Centre Hospitalier Universitaire de Nice

A Mixed-methods Study to Identify Meaningful Aspects of Health for Adults With Dementia, Their Care Partners and Healthcare Practitioners

The aim of this study is to describe, using a non-interventional survey, the relevant aspects of health in adults with ADRD for the patients themselves, their carers and healthcare professionals. Commonalities and differences between these three stakeholders and according to the severity of the dementia will also be studied.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Alzheimer's disease and related disorders (ADRD) are the sixth leading cause of death among adults. Currently, more than 55 million people worldwide are living with the disease, with nearly 10 million new cases each year. ADRD causes significant economic and care burdens for thousands of families and their communities, with over 60% of caregivers developing depressive symptoms. ADRD is ranked among the most costly diseases for society . It is therefore necessary to intervene in order to combat this devastating disease. As recent guidance from the Food and Drug Administration indicates, there is a need to identify areas and mechanisms for real-world change to improve patients' quality of life.

The European Medicines Agency Expert Advisory Group concluded that there was no consensus on validated outcomes in early-stage ADRD and identified the need to fill these gaps.

To demonstrate the utility of any clinical outcome assessment, it's important to link these measures to real-world experiences. And to create this link, research is needed to better understand the meaningful aspects of the health of Alzheimer's patients and their caregivers. In addition, it is important to understand how these MAHs relate to clinicians' perspectives and their approach to assessing disease severity.

Thus, the aim of this study is to describe, using a non-interventional survey, the relevant aspects of health in adults with ADRD for the patients themselves, their carers and healthcare professionals.

Participants with Alzheimer's disease and related dementia and caregivers will be recruited through the Memory Clinic at the Geriatric Hospital in Nice.

Healthcare practitioners working at Centre de Mémoire de Ressources et de Recherche, or outside the Centre , and actively treating a minimum of 10 adults with ADRD, including: neurologists, geriatricians, psychiatrists, neuropsychologists and social workers will be proposed to participate.

All participants will be given a web link to access the survey and will complete it remotely. The survey will take approximately 30 minutes to complete.

Study Type

Observational

Enrollment (Estimated)

175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Nice, France, 06100
        • CHU de Nice
        • Principal Investigator:
          • Guillaume SACCO, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults with ADRD, their care givers and Health-care practitioners

Description

Adults with Alzheimer's disease and related dementia:

  1. ADRD inclusive of the following :

    • Mild dementia due to Alzheimer's disease inclusive of:

      • Mild Cognitive Impairment (MCI),
      • Prodromal Alzheimer's disease,
      • Subjective cognitive impairment,
      • Early onset dementia due to Alzheimer's disease,
      • Mild Alzheimer's Disease
    • Frontotemporal dementia (FTD) - Frontal variant
    • Frontotemporal dementia (FTD) - Primary progressive aphasia
    • Lewy Body dementia (LBD)
    • Vascular dementia
  2. Ability to read, understand and express non opposition
  3. Aged 50 years or older
  4. Patient affiliated to the social security system

Care partners:

  1. Unpaid care partners for adults with Alzheimer's disease and related dementia

    ■ A care partner is the primary person who cares for an adult with ADRD, including but not limited to partner, spouse, family member, or significant other of the individual with ADRD. Care partners will be recruited where they care for patients with:

    • Mild dementia due to Alzheimer's disease (inclusive of Mild Cognitive Impairment (MCI), Prodromal Alzheimer's disease, Subjective cognitive impairment, Early onset dementia due to Alzheimer's disease, Mild Alzhiemer's Disease )
    • Moderate to severe dementia due to Alzheimer's disease
    • Frontotemporal dementia (FTD) - Frontal variant
    • Frontotemporal dementia (FTD) - Primary progressive aphasia
    • Lewy Body dementia (LBD)
    • Vascular dementia
  2. Delivers at least 10 hours of additional care per week since diagnosis
  3. Ability to read, understand and express non opposition
  4. Aged 18 years or older
  5. Subject affiliated to the social security system

Health-care practitioners

  1. Healthcare practitioners actively treating adults with ADRD, including: neurologists, geriatricians, psychiatrists, neuropsychologists and social workers
  2. Currently treats a minimum of 10 ADRD patients
  3. express non opposition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults with Alzheimer's disease and related dementia
75 patients with ADRD
Other: Survey
Each group will have to complete a questionnaire online, taking about 30 minutes.
Care partners of Adults with Alzheimer's disease and related dementia
75 care partners for adults with ADRD
Other: Survey
Each group will have to complete a questionnaire online, taking about 30 minutes.
Clinicians who treat patients with Alzheimer's disease and related dementia
25 healthcare practitioners
Other: Survey
Each group will have to complete a questionnaire online, taking about 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the meaningful aspects of health that patients, care partners and clinicians consider most important when considering improvement in the ADRD patient's condition and when considering prevention of decline in the ADRD patient's condition
Time Frame: day 1
questionnaire specially developed for the study containing a set of MAH ranking exercises and free text response questions
day 1
Assessment of the meaningful aspects of health that patients, care partners and clinicians consider most important when considering prevention of decline in the ADRD patient's condition
Time Frame: day1
questionnaire specially developed for the study containing a set of MAH ranking exercises and free text response questions
day1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-PP-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on Survey

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe