CaregiversNCT00362284
Comprehensive Support for Alzheimer's Disease Caregivers
A study testing NYUCI-AC in people with Caregivers and Stress, run by University of Minnesota at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of a comprehensive counseling and support intervention for people who care for parents with Alzheimer's disease (AD) or other dementias on outcomes such as stress, depression and ability to postpone or avoid nursing home placement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers, Stress, Depression
- What is being tested?
- NYUCI-AC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2005to Jan 2012
- Phase
- Interventional
- 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
- Participant (i.e., adult child) must be the 'primary' caregiver of the patient with a diagnosis of dementia (i.e., the first person called if the patient is in need of help) at the time of the baseline interview
- Must be a daughter, son, daughter-in-law, or son-in-law of the patient
- Patient must live in the community (i.e., at home, with the caregiver, with other relatives)
- Sees the individual with dementia once a week or more
Who cannot join
- Unable to understand or speak English comfortably
- Inadequate hearing
- Unwilling to participate in the study or sign the consent form
- Suffered from or received treatment for an emotional or psychological disorder, such as depression, anxiety, or some other type of psychotic episode, within the past 6 months
- Not physically able to participate
- Received counseling for problems arising as a caregiver
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota, School of Nursing, 6-150 Weaver-Densford Hall
Minneapolis, Minnesota, 55455
Silberstein Institute for Aging and Dementia, Department of Psychiatry, NYU School of Medicine
New York, New York, 10016
About this study
Official title: Expanded Counseling and Support for Adult Children Caring for Parents With Alzheimer's Disease or Similar Disorders
The purpose of this study is to determine the effectiveness of a comprehensive counseling and support intervention for people who care for parents with Alzheimer's disease (AD) or other dementias on outcomes such as stress, depression and ability to postpone or avoid nursing home placement.
Read the detailed description
Although a range of studies have examined the stress and depression of family caregivers of persons suffering from dementia, the effectiveness of psychosocial interventions to assist caregiving families and their disabled elderly relatives is uncertain. The comprehensive support protocol to be implemented, the Enhanced Counseling and Support (ECS) program, has been successfully implemented at the Silberstein Aging and Dementia Research Center of New York University School of Medicine (NYU-ADRC) over the past 19 years. However, the initial evaluation of the ECS was limited to a single geographic area (New York City proper) and a specific type of dementia caregiver (spouses).
The specific aims of this 4-year project are as follows: 1) Examine whether the ECS can achieve positive outcomes for adult child caregivers. Few psychosocial interventions are directed specifically at adult child caregivers, and evaluating the ECS in adult child caregiving situations, which few studies have done, will further demonstrate the effectiveness of this program and add considerably to the AD caregiver intervention literature; and 2) Determine if the ECS, an intervention of proven efficacy for AD caregivers in a northern U.S. urban community (New York City), will also be effective in alleviating negative outcomes among AD caregivers at a Midwestern project site. The study will ascertain whether the comprehensive support program developed at NYU is generalizable to caregivers from areas other than the New York City area and leads to similar benefits that are maintained over long periods of time (i.e., up to 3.5 years).
In order to accomplish the specific aims of the project, the following study hypotheses have been proposed:
- Adult child caregivers in the treatment conditions of the University of Minnesota (UM) and NYU-ADRC will report similar decreases on measures of stress when compared to usual-contact controls;
- Adult child caregivers in the intervention conditions at both sites will develop improved social support resources and experience significantly greater decreases of family conflict in a similar manner;
- Adult child caregivers in the treatment conditions at UM and NYU-ADRC will report similar decreases on global measures of psychological distress, such as depression. Similarly, treatment caregivers will report greater increases in subjective health than their counterparts in the usual-contact control; and
- Membership in the treatment condition of the ECS and its benefits (e.g., increased social support, decreased stress) will lead to delayed institutionalization (e.g., nursing home placement) of care recipients at the UM and NYU-ADC sites.
- Conditions
- Caregivers, Stress, Depression
- Being tested
- NYUCI-AC
- Keywords
- Alzheimer's disease, coping, quality of life, caregiving
- Medical subject headings
- Depression, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NYUCI-ACBehavioural
Approximately six individual and family consultation sessions (2 individual, 3 family, 1 individual) within the first 4 months with adult child caregivers and/or their family members; support group participation (recommended at least once a month) after the completion of the individual and family consultation sessions for the duration of the project (up to 3 years after the intake interview); ad hoc consultation (ongoing in-person, telephone, or email support on an as-needed basis) for the duration of the project (up to 3 years after the intake interview); New York University Caregiver Intervention
| Study group | Role | What they receive |
|---|---|---|
| NYUCI-AC group | Experimental | Adult children in this arm received the NYUCI-AC intervention, which consisted of 6 individual and family counseling sessions, the offering of an adult child specific support group, and the provision of ad hoc, or ongoing, consultation throughout the duration of participation. Receives: Behavioral: NYUCI-AC |
| Usual care control | No intervention | Adult children randomly assigned to the usual care control did not receive the NYUCI-AC intervention. If they were in crisis or required support, the NYUCI-AC counselors provided information and referral on an as-needed basis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care recipient nursing home/institutional placement
Adult child caregivers self-reported whether the care recipient was admitted to a residential care setting and the date of admission.
Measured: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
Caregiver emotional stress
Measures of role captivity, role overload, and general perceived stress.
Measured: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
caregiver depression
The Geriatric Depression Scale.
Measured: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
caregiver social support
Three single items that measured perceptions of support received by the adult child caregiver.
Measured: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
Secondary outcomes (2)
Caregiver subjective health
Single item self-reported health as well as measures derived from the OARS.
Measured: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
secondary stressors
Measures of family and role conflict.
Measured: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study startSep 2005
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Joseph E. Gaugler, PhD, Principal investigator, University of Minnesota, Center on Aging, Center for Gerontological Nursing, School of NursingMary Mittelman, DrPH, Principal investigator, Silberstein Institute for Aging and Dementia, Department of Psychiatry, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362284
- Sponsor's protocol ID
- H13355B
- Other IDs
- R01AG022066
- Status last verified
- Feb 2022
- First submitted
- 8 Aug 2006
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gaugler JE, Reese M, Mittelman MS. Process Evaluation of the NYU Caregiver Intervention-Adult Child. Gerontologist. 2018 Mar 19;58(2):e107-e117. doi: 10.1093/geront/gnx048.
PubMed 29562359Gaugler JE, Reese M, Mittelman MS. Effects of the NYU caregiver intervention-adult child on residential care placement. Gerontologist. 2013 Dec;53(6):985-97. doi: 10.1093/geront/gns193. Epub 2013 Jan 20.
PubMed 23339050Gaugler JE, Reese M, Mittelman MS. Effects of the Minnesota Adaptation of the NYU Caregiver Intervention on Primary Subjective Stress of Adult Child Caregivers of Persons With Dementia. Gerontologist. 2016 Jun;56(3):461-74. doi: 10.1093/geront/gnu125. Epub 2015 Jan 27.
PubMed 25628299Gaugler JE, Reese M, Mittelman MS. Effects of the Minnesota Adaptation of the NYU Caregiver Intervention on Depressive Symptoms and Quality of Life for Adult Child Caregivers of Persons with Dementia. Am J Geriatr Psychiatry. 2015 Nov;23(11):1179-92. doi: 10.1016/j.jagp.2015.06.007. Epub 2015 Jun 25.
PubMed 26238226Gaugler JE, Reese M, Mittelman MS. The Effects of a Comprehensive Psychosocial Intervention on Secondary Stressors and Social Support for Adult Child Caregivers of Persons With Dementia. Innov Aging. 2018 Jun;2(2):igy015. doi: 10.1093/geroni/igy015. Epub 2018 Jun 22.
PubMed 30009268Albers, Elizabeth, A. (2020). A Longitudinal Analysis of the Effects of the NYU Caregiver Intervention-Adult Child on Subjective Health. Retrieved from the University of Minnesota Digital Conservancy, http://hdl.handle.net/11299/217050.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Counseling and Support for Adult Children Caring for Parents With Alzheimer's Disease or Similar Disorders
- ClinicalTrials.gov ID
- NCT00362284
- Acronym / sponsor ID
- H13355B
- Conditions
- Caregivers, Stress, Depression
- Keywords
- Alzheimer's disease, coping, quality of life, caregiving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Aug 2006 (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.
The purpose of this study is to determine the effectiveness of a comprehensive counseling and support intervention for people who care for parents with Alzheimer's disease (AD) or other dementias on outcomes such as stress, depression and ability to postpone or avoid nursing home placement.
Detailed description
Although a range of studies have examined the stress and depression of family caregivers of persons suffering from dementia, the effectiveness of psychosocial interventions to assist caregiving families and their disabled elderly relatives is uncertain. The comprehensive support protocol to be implemented, the Enhanced Counseling and Support (ECS) program, has been successfully implemented at the Silberstein Aging and Dementia Research Center of New York University School of Medicine (NYU-ADRC) over the past 19 years. However, the initial evaluation of the ECS was limited to a single geographic area (New York City proper) and a specific type of dementia caregiver (spouses).
The specific aims of this 4-year project are as follows: 1) Examine whether the ECS can achieve positive outcomes for adult child caregivers. Few psychosocial interventions are directed specifically at adult child caregivers, and evaluating the ECS in adult child caregiving situations, which few studies have done, will further demonstrate the effectiveness of this program and add considerably to the AD caregiver intervention literature; and 2) Determine if the ECS, an intervention of proven efficacy for AD caregivers in a northern U.S. urban community (New York City), will also be effective in alleviating negative outcomes among AD caregivers at a Midwestern project site. The study will ascertain whether the comprehensive support program developed at NYU is generalizable to caregivers from areas other than the New York City area and leads to similar benefits that are maintained over long periods of time (i.e., up to 3.5 years).
In order to accomplish the specific aims of the project, the following study hypotheses have been proposed:
- Adult child caregivers in the treatment conditions of the University of Minnesota (UM) and NYU-ADRC will report similar decreases on measures of stress when compared to usual-contact controls;
- Adult child caregivers in the intervention conditions at both sites will develop improved social support resources and experience significantly greater decreases of family conflict in a similar manner;
- Adult child caregivers in the treatment conditions at UM and NYU-ADRC will report similar decreases on global measures of psychological distress, such as depression. Similarly, treatment caregivers will report greater increases in subjective health than their counterparts in the usual-contact control; and
- Membership in the treatment condition of the ECS and its benefits (e.g., increased social support, decreased stress) will lead to delayed institutionalization (e.g., nursing home placement) of care recipients at the UM and NYU-ADC sites.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NYUCI-AC group | Experimental | Behavioral: NYUCI-ACAdult children in this arm received the NYUCI-AC intervention, which consisted of 6 individual and family counseling sessions, the offering of an adult child specific support group, and the provision of ad hoc, or ongoing, consultation throughout the duration of participation. |
| Usual care control | No intervention | –Adult children randomly assigned to the usual care control did not receive the NYUCI-AC intervention. If they were in crisis or required support, the NYUCI-AC counselors provided information and referral on an as-needed basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant (i.e., adult child) must be the 'primary' caregiver of the patient with a diagnosis of dementia (i.e., the first person called if the patient is in need of help) at the time of the baseline interview
- Must be a daughter, son, daughter-in-law, or son-in-law of the patient
- Patient must live in the community (i.e., at home, with the caregiver, with other relatives)
- Sees the individual with dementia once a week or more
Key exclusion criteria (6 listed)
- Unable to understand or speak English comfortably
- Inadequate hearing
- Unwilling to participate in the study or sign the consent form
- Suffered from or received treatment for an emotional or psychological disorder, such as depression, anxiety, or some other type of psychotic episode, within the past 6 months
- Not physically able to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NYUCI-ACApproximately six individual and family consultation sessions (2 individual, 3 family, 1 individual) within the first 4 months with adult child caregivers and/or their family members; support group participation (recommended at least once a month) after the completion of the individual and family consultation sessions for the duration of the project (up to 3 years after the intake interview); ad hoc consultation (ongoing in-person, telephone, or email support on an as-needed basis) for the duration of the project (up to 3 years after the intake interview); New York University Caregiver Intervention | Behavioural | NYUCI-AC group |
Primary outcome
Care recipient nursing home/institutional placement
Time frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
Adult child caregivers self-reported whether the care recipient was admitted to a residential care setting and the date of admission.
Caregiver emotional stress
Time frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
Measures of role captivity, role overload, and general perceived stress.
caregiver depression
Time frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
The Geriatric Depression Scale.
caregiver social support
Time frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
Three single items that measured perceptions of support received by the adult child caregiver.
2 secondary outcomes
Caregiver subjective health
Time frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
secondary stressors
Time frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
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 11 Feb 2022.
- Background: PubMed 29562359Gaugler JE, Reese M, Mittelman MS. Process Evaluation of the NYU Caregiver Intervention-Adult Child. Gerontologist. 2018 Mar 19;58(2):e107-e117. doi: 10.1093/geront/gnx048.
- Results publication: PubMed 23339050Gaugler JE, Reese M, Mittelman MS. Effects of the NYU caregiver intervention-adult child on residential care placement. Gerontologist. 2013 Dec;53(6):985-97. doi: 10.1093/geront/gns193. Epub 2013 Jan 20.
- Results publication: PubMed 25628299Gaugler JE, Reese M, Mittelman MS. Effects of the Minnesota Adaptation of the NYU Caregiver Intervention on Primary Subjective Stress of Adult Child Caregivers of Persons With Dementia. Gerontologist. 2016 Jun;56(3):461-74. doi: 10.1093/geront/gnu125. Epub 2015 Jan 27.
- Results publication: PubMed 26238226Gaugler JE, Reese M, Mittelman MS. Effects of the Minnesota Adaptation of the NYU Caregiver Intervention on Depressive Symptoms and Quality of Life for Adult Child Caregivers of Persons with Dementia. Am J Geriatr Psychiatry. 2015 Nov;23(11):1179-92. doi: 10.1016/j.jagp.2015.06.007. Epub 2015 Jun 25.
- Results publication: PubMed 30009268Gaugler JE, Reese M, Mittelman MS. The Effects of a Comprehensive Psychosocial Intervention on Secondary Stressors and Social Support for Adult Child Caregivers of Persons With Dementia. Innov Aging. 2018 Jun;2(2):igy015. doi: 10.1093/geroni/igy015. Epub 2018 Jun 22.
- Results publicationAlbers, Elizabeth, A. (2020). A Longitudinal Analysis of the Effects of the NYU Caregiver Intervention-Adult Child on Subjective Health. Retrieved from the University of Minnesota Digital Conservancy, http://hdl.handle.net/11299/217050.
Related trials for Caregivers
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
The Decision To Enroll In Therapeutic Clinical Trials In A Pediatric Cancer Clinical Network
Knowledge, Attitudes, Practice
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Recruiting
A Web-Based Dyadic Intervention for Colorectal Cancer
Colorectal Carcinoma
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.
Joseph E. Gaugler, PhD principal investigator
University of Minnesota, Center on Aging, Center for Gerontological Nursing, School of Nursing
Mary Mittelman, DrPH principal investigator
Silberstein Institute for Aging and Dementia, Department of Psychiatry, NYU School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NYUCI-AC in people with Caregivers and Stress, run by University of Minnesota at 2 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 4 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 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Care recipient nursing home/institutional placement (time frame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00362284, which also lists 6 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 11 Feb 2022.