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

Alzheimer Disease Clinical Trial

— DiME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06242574
• Other study ID #: 23-PP-11
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Guillaume SACCO, MD
• Phone: 04 92 03 47 51
• Email: sacco.g[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 175
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Other:
• Survey
Each group will have to complete a questionnaire online, taking about 30 minutes.

Locations

Country	Name	City	State
France	chu de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	questionnaire specially developed for the study containing a set of MAH ranking exercises and free text response questions	day 1
Primary	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	questionnaire specially developed for the study containing a set of MAH ranking exercises and free text response questions	day1