- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01738386
Living With Frontotemporal Dementia
Challenges of Living With Frontotemporal Dementia: The Perspective of the Affected Individual
Background:
- Frontotemporal dementia (FTD) is the second most common cause of early-onset dementia. Alzheimer s disease is the most common. Alzheimer s disease happens most often in the elderly, but FTD typically appears between 40 and 60 years of age. It also has a strong genetic component: Up to 40% of FTD cases are linked to positive family histories. Earlier diagnoses and genetic tests mean that people with FTD will spend more years in earlier stages of disease, aware that they have it. However, few studies have looked at the personal experiences or coping styles of people with FTD. Researchers want to interview people with FTD and their caregivers to understand their experiences with the disease. This information will help create better treatments and therapies for those affected by FTD.
Objectives:
- To study the experiences of persons with FTD and their primary caregivers.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with FTD.
- Primary caregivers (spouse or partner at least 18 years of age) of individuals who have been diagnosed with FTD.
Design:
- Before FTD participants are recruited, a pilot study will test the interview questions. This pilot study will be given to people with Alzheimer s disease and their caregivers. It will study how well people with dementia understand the interview questions.
- FTD study participants will be recruited through dementia care centers.
- All participants will have in-person interviews. These interviews will take up to 1 hour.
- Participants with FTD will answer questions about their experience with the disease. They will talk about their mental abilities, challenges, and coping strategies.
- Caregivers will answer questions about their experience in caring for someone with FTD. They will talk about their challenges and coping strategies. They will also talk about the person with FTD, and how aware they believe that the person is of the dementia symptoms.
- All participants will receive a small gift card as compensation for their time.
- No treatment will be provided as part of this study.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins University
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New York
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New York, New York, United States, 10032-3784
- Columbia University
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104-6056
- University of Pennsylvania
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION AND EXCLUSION CRITERIA:
Participants with FTD must:
- Be affected with any variant of frontotemporal dementia and have documented cognitive impairment
Have this diagnosis made by a behavioral neurologist, neuropsychologist, psychiatrist, or a group consensus of any of the above in a specialized dementia center
- For patients recruited through the contact physicians at Johns Hopkins Hospital, University of Pennsylvania, or Columbia University Medical Center, this diagnosis will be verified through personal communication between the interviewer (WM) and the contact physician and through the patients medical records.
- For patients recruited through a foundation, patient support group or Clinicaltrials.gov, the patients listed dementia care specialist will be contacted to verify the diagnosis, or the appropriate documents obtained through a release of medical information form.
- Be assessed to be in the none (1) to mild (2) impairment category on the Dementia Disability Rating. The assessment must be performed by a dementia care specialist with a medical degree.
- Have an onset of disease at or more than three months before the interview date. This date may or may not differ from the actual date of diagnosis.
- Pass the consent comprehension assessment
- Be 18 or older and speak fluent English
Caregivers participants must:
- Be a spouse or partner who provides day-to-day care for the affected individual.
- Spend a minimum of 16 hours per week, on average in a month, in direct contact with the affected individual.
- NOT be a non-spousal relative, friend, healthcare provider, or hired help.
- Pass the consent comprehension assessment
- Be 18 or older and speak fluent English.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Publications and helpful links
General Publications
- Ablitt A, Jones G, Muers J. Awareness of carer distress in people with dementia. Int J Geriatr Psychiatry. 2010 Dec;25(12):1246-52. doi: 10.1002/gps.2461.
- Baldelli MV, Pirani A, Motta M, Abati E, Mariani E, Manzi V. Effects of reality orientation therapy on elderly patients in the community. Arch Gerontol Geriatr. 1993 Nov-Dec;17(3):211-8. doi: 10.1016/0167-4943(93)90052-j.
- Bates J, Boote J, Beverley C. Psychosocial interventions for people with a milder dementing illness: a systematic review. J Adv Nurs. 2004 Mar;45(6):644-58. doi: 10.1046/j.1365-2648.2003.02959.x.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Dementia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID Numbers
- 999912153
- 12-HG-N153
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.
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