DementiaNCT06471660
Family Caregiver Online Survey (Dementia and Swallowing Difficulties)
An observational study of Dementia and Dysphagia, run by University of Oregon at 1 site in United States.
Trial summary
The Family Caregiver Survey is a one-time, 30-minute, online survey for people living with and caring for a family member with dementia. The goal of this research is to explore the needs of family caregivers, specifically when it comes to managing swallowing difficulties (dysphagia). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Dysphagia, Dementia Alzheimers
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 14 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Unpaid, adults living with and caring for a family member with dementia with or without swallowing difficulties.
Who may be able to join
- Be a caregiver for a family member (or chosen family member) with dementia
- Have been caregiving for at least 2 months
- Live at home with the care recipient
- Not be paid for the care provided
- Be over the age of 18
- Live in the US
Who cannot join
- Not be a caregiver for a family member (or chosen family member) with dementia
- Have been caregiving for less than 2 months
- Not live at home with the care recipient
- Be paid for the care provided
- Be under the age of 18
- Live outside in the US
Trial locations and contacts
1 site in 1 country.
United States1 site
Remote study offered by the University of Oregon
Eugene, Oregon, 97403
About this study
Official title: Influence of Swallowing Impairment on Burden Among Caregivers of Persons With Alzheimer's Disease and Related Dementias
The Family Caregiver Survey is a one-time, 30-minute, online survey for people living with and caring for a family member with dementia. The goal of this research is to explore the needs of family caregivers, specifically when it comes to managing swallowing difficulties (dysphagia).
Read the detailed description
This research aims to increase our understanding of dysphagia-related caregiver burden and inform the development of a comprehensive dysphagia intervention, one that promotes the health and quality of life of both the caregiver and the person with dementia.
Aim 1. Quantify dysphagia's contribution to burden among family caregivers of persons with dementia across the disease trajectory to identify when may be best to intervene.
Aim 2. Characterize the moderating effects of caregiver readiness and support on dysphagia-related burden and care recipient quality of life to identify what are the most appropriate intervention targets.
- Conditions
- Dementia, Dysphagia, Dementia Alzheimers, Dementia, Vascular, Dementia, Mixed, Dementia With Lewy Bodies
- Keywords
- caregiver, family caregiver, care partner, survey, remote, virtual, dementia, dysphagia
- Medical subject headings
- Dementia, Deglutition Disorders, Alzheimer Disease, Dementia, Vascular, Mixed Dementias, Lewy Body Disease, Lymphoma, Follicular, Pick Disease of the Brain
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Information
Demographic Questionnaire
Measured: Baseline
Eight-item Informant Interview to Differentiate Aging and Dementia (AD8)
The AD8 is a screening test that is sensitive to detecting early cognitive changes associated with dementia. AD8 is a scale from 0-8, with higher scores signifying more severe cognitive decline.
Measured: Baseline
Global Deterioration Scale (GDS)
The Global Deterioration Scale (GDS) provides an overview of the stages of cognitive function for those suffering from a primary degenerative dementia such as Alzheimer's disease. GDS is a scale from 0-7, with higher scores signifying more severe cognitive decline.
Measured: Baseline
International Dysphagia Diet Standardisation Initiative Functional Diet Scale (IDDSI-FDS)
The IDDSI-FDS is a validated tool that was created in order to capture degree of diet texture restriction. Degree of diet texture restriction has been previously used in the literature as a self- or informant-reported proxy measure for dysphagia severity given that it represents the functional impact of the dysphagia on daily eating. The scale ranges from 0-8, higher scores indicating less diet texture restriction.
Measured: Baseline
Zarit Burden Interview
The Zarit Burden Interview is a valid, reliable, and widely used self-report measure designed to quantify general caregiver burden, incorporating both objective and subjective burden. It queries common areas of concern, including those related to finances, health, social life, and interpersonal relationships, and explores both personal and role strain. Scores range from 0-88, with higher scores signifying more burden.
Measured: Baseline
Caregiver Analysis of Reported Experiences with Swallowing (CARES)
The CARES is a valid and reliable questionnaire designed to screen for dysphagia-related caregiver burden. The 26-item questionnaire explores the potentially burdensome, more objective behavioral and functional changes that have occurred as a result of dysphagia (Part A) and the more subjective stressors experienced by the caregiver (Part B). Scores range from 0-26, with higher scores signifying more dysphagia-related caregiver burden.
Measured: Baseline
Caregiving Competence Scale
The Caregiving Competence Scale, developed for caregivers of persons with dementia and adapted for dysphagia management, is a valid and reliable four-item scale measuring caregivers' perceived adequacy of their own performance. Scores range from 0-12, with higher scores signifying more perceived competence.
Measured: Baseline
Dysphagia-Related Knowledge Questionnaire
The Dysphagia-Related Knowledge Questionnaire is a study-specific measure assessing caregiver knowledge of functional aspects of dysphagia and dysphagia management, including key definitions, signs/symptoms, management techniques, consequences, and the dysphagia trajectory. Scores can range from 0-13, with higher scores signifying more dysphagia-related knowledge.
Measured: Baseline
Preparedness for Caregiving Scale
The Preparedness for Caregiving Scale, adapted for dysphagia management, explores caregivers' perceived preparation related to caring for the physical and emotional needs of their care recipient. Scores range from 0-12, with higher scores signifying more perceived preparedness.
Measured: Baseline
Multidimensional Scale of Perceived Social Support (MSPSS)
The MSPSS is a self-report measure of subjectively assessed social support that has been validated for use within a variety of populations across the lifespan. Scores range from 12-84, with higher scores signifying more perceived social support.
Measured: Baseline
Eating Assessment Tool 10 (EAT-10)
The EAT-10 is a validated, widely used clinically, and easy-to-administer 10-item symptom-specific swallowing outcomes tool designed to understand the extent to which an individual's quality of life has been impacted by dysphagia. While generally completed by patients themselves, previous research has suggested that proxies can reliably report on observable symptoms, such as those rated on the EAT-10 related to swallow function. Scores range from 0-40, with higher scores signifying more severe dysphagia symptoms and greater impact to quality of life.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start7 Nov 2023
- Primary completion12 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Samantha Shune, Principal investigator, The University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471660
- Sponsor's protocol ID
- STUDY00000738
- Status last verified
- Jun 2025
- First submitted
- 24 May 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Swallowing Impairment on Burden Among Caregivers of Persons With Alzheimer's Disease and Related Dementias
- ClinicalTrials.gov ID
- NCT06471660
- Acronym / sponsor ID
- STUDY00000738
- Conditions
- Dementia, Dysphagia, Dementia Alzheimers, Dementia, Vascular, Dementia, Mixed, Dementia With Lewy Bodies
- Keywords
- caregiver, family caregiver, care partner, survey, remote, virtual, dementia, dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 12 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Family Caregiver Survey is a one-time, 30-minute, online survey for people living with and caring for a family member with dementia. The goal of this research is to explore the needs of family caregivers, specifically when it comes to managing swallowing difficulties (dysphagia).
Detailed description
This research aims to increase our understanding of dysphagia-related caregiver burden and inform the development of a comprehensive dysphagia intervention, one that promotes the health and quality of life of both the caregiver and the person with dementia.
Aim 1. Quantify dysphagia's contribution to burden among family caregivers of persons with dementia across the disease trajectory to identify when may be best to intervene.
Aim 2. Characterize the moderating effects of caregiver readiness and support on dysphagia-related burden and care recipient quality of life to identify what are the most appropriate intervention targets.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Unpaid, adults living with and caring for a family member with dementia with or without swallowing difficulties.
Key inclusion criteria (6 listed)
- Be a caregiver for a family member (or chosen family member) with dementia
- Have been caregiving for at least 2 months
- Live at home with the care recipient
- Not be paid for the care provided
- Be over the age of 18
Key exclusion criteria (6 listed)
- Not be a caregiver for a family member (or chosen family member) with dementia
- Have been caregiving for less than 2 months
- Not live at home with the care recipient
- Be paid for the care provided
- Be under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic Information
Time frame: Baseline
Demographic Questionnaire
Eight-item Informant Interview to Differentiate Aging and Dementia (AD8)
Time frame: Baseline
The AD8 is a screening test that is sensitive to detecting early cognitive changes associated with dementia. AD8 is a scale from 0-8, with higher scores signifying more severe cognitive decline.
Global Deterioration Scale (GDS)
Time frame: Baseline
The Global Deterioration Scale (GDS) provides an overview of the stages of cognitive function for those suffering from a primary degenerative dementia such as Alzheimer's disease. GDS is a scale from 0-7, with higher scores signifying more severe cognitive decline.
International Dysphagia Diet Standardisation Initiative Functional Diet Scale (IDDSI-FDS)
Time frame: Baseline
The IDDSI-FDS is a validated tool that was created in order to capture degree of diet texture restriction. Degree of diet texture restriction has been previously used in the literature as a self- or informant-reported proxy measure for dysphagia severity given that it represents the functional impact of the dysphagia on daily eating. The scale ranges from 0-8, higher scores indicating less diet texture restriction.
Zarit Burden Interview
Time frame: Baseline
The Zarit Burden Interview is a valid, reliable, and widely used self-report measure designed to quantify general caregiver burden, incorporating both objective and subjective burden. It queries common areas of concern, including those related to finances, health, social life, and interpersonal relationships, and explores both personal and role strain. Scores range from 0-88, with higher scores signifying more burden.
Caregiver Analysis of Reported Experiences with Swallowing (CARES)
Time frame: Baseline
The CARES is a valid and reliable questionnaire designed to screen for dysphagia-related caregiver burden. The 26-item questionnaire explores the potentially burdensome, more objective behavioral and functional changes that have occurred as a result of dysphagia (Part A) and the more subjective stressors experienced by the caregiver (Part B). Scores range from 0-26, with higher scores signifying more dysphagia-related caregiver burden.
Caregiving Competence Scale
Time frame: Baseline
The Caregiving Competence Scale, developed for caregivers of persons with dementia and adapted for dysphagia management, is a valid and reliable four-item scale measuring caregivers' perceived adequacy of their own performance. Scores range from 0-12, with higher scores signifying more perceived competence.
Dysphagia-Related Knowledge Questionnaire
Time frame: Baseline
The Dysphagia-Related Knowledge Questionnaire is a study-specific measure assessing caregiver knowledge of functional aspects of dysphagia and dysphagia management, including key definitions, signs/symptoms, management techniques, consequences, and the dysphagia trajectory. Scores can range from 0-13, with higher scores signifying more dysphagia-related knowledge.
Preparedness for Caregiving Scale
Time frame: Baseline
The Preparedness for Caregiving Scale, adapted for dysphagia management, explores caregivers' perceived preparation related to caring for the physical and emotional needs of their care recipient. Scores range from 0-12, with higher scores signifying more perceived preparedness.
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Baseline
The MSPSS is a self-report measure of subjectively assessed social support that has been validated for use within a variety of populations across the lifespan. Scores range from 12-84, with higher scores signifying more perceived social support.
Eating Assessment Tool 10 (EAT-10)
Time frame: Baseline
The EAT-10 is a validated, widely used clinically, and easy-to-administer 10-item symptom-specific swallowing outcomes tool designed to understand the extent to which an individual's quality of life has been impacted by dysphagia. While generally completed by patients themselves, previous research has suggested that proxies can reliably report on observable symptoms, such as those rated on the EAT-10 related to swallow function. Scores range from 0-40, with higher scores signifying more severe dysphagia symptoms and greater impact to quality of life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Shune principal investigator
The University of Oregon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Dysphagia, run by University of Oregon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Information (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.