AdaptationNCT01738386
Living With Frontotemporal Dementia
An observational study of Adaptation, run by National Human Genome Research Institute (NHGRI) at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adaptation
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jun 2012to 24 Feb 2016
- 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
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Columbia University
New York, New York, 10032-3784
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6056
About this study
Official title: 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.
Read more
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.
Read the detailed description
The purpose of the proposed study is to qualitatively explore the experience, conceptualization of disease, and coping strategies of persons with frontotemporal dementia (FTD). FTD is the second most prevalent cause of early-onset dementia after Alzheimer disease, and has a significant genetic origin. Currently, there are no published studies describing the personal experience or coping styles of individuals with FTD. To accomplish the study s objectives, semi-structured interviews will be conducted with 20 to 30 dyads of patients with FTD and their spouse/partner caregivers. The caregivers will be interviewed about the experience of the person with FTD. Both sets of interviews will be audiotaped, transcribed and subjected to thematic content analysis. Themes emerging in both members of each dyad will be compared and contrasted in order to understand the subjective experience of the disease. Insight into the personal illness experiences of individuals with FTD will inform future clinical intervention studies.
- Conditions
- Adaptation
- Keywords
- Adaptation, Coping, Presenile Dementia, Caregiver Burden
- Medical subject headings
- Alzheimer Disease, Caregiver Burden
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study start13 Jun 2012
- Study completion24 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AdaptationStudies 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
- Time perspective
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Barbara B Biesecker, Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738386
- Sponsor's protocol ID
- 999912153
- Other IDs
- 12-HG-N153
- Status last verified
- 24 Feb 2016
- First submitted
- 28 Nov 2012
- Last updated
- 26 Jul 2018
- Results posted
- No
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.
PubMed 20033903Baldelli 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.
PubMed 15374320Bates 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.
PubMed 15012642
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenges of Living With Frontotemporal Dementia: The Perspective of the Affected Individual
- ClinicalTrials.gov ID
- NCT01738386
- Acronym / sponsor ID
- 999912153
- Conditions
- Adaptation
- Keywords
- Adaptation, Coping, Presenile Dementia, Caregiver Burden
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 13 Jun 2012
- Study completion
- 24 Feb 2016
- First posted
- 30 Nov 2012 (estimated)
- 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.
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.
Detailed description
The purpose of the proposed study is to qualitatively explore the experience, conceptualization of disease, and coping strategies of persons with frontotemporal dementia (FTD). FTD is the second most prevalent cause of early-onset dementia after Alzheimer disease, and has a significant genetic origin. Currently, there are no published studies describing the personal experience or coping styles of individuals with FTD. To accomplish the study s objectives, semi-structured interviews will be conducted with 20 to 30 dyads of patients with FTD and their spouse/partner caregivers. The caregivers will be interviewed about the experience of the person with FTD. Both sets of interviews will be audiotaped, transcribed and subjected to thematic content analysis. Themes emerging in both members of each dyad will be compared and contrasted in order to understand the subjective experience of the disease. Insight into the personal illness experiences of individuals with FTD will inform future clinical intervention studies.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- 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
Key exclusion criteria (0 listed)
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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 20033903Ablitt 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.
- Background: PubMed 15374320Baldelli 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.
- Background: PubMed 15012642Bates 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.
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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.
Barbara B Biesecker principal investigator
National Human Genome Research Institute (NHGRI)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adaptation, run by National Human Genome Research Institute (NHGRI) at 3 sites 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 15 inclusion and 0 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: stopped early, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01738386, which also lists 3 linked publications.
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 26 Jul 2018.