Clinical trial NCT00362284: Comprehensive Support for Alzheimer's Disease Caregivers
Official title: Expanded Counseling and Support for Adult Children Caring for Parents With Alzheimer's Disease or Similar Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers
Stress
Depression
Keywords: Alzheimer's disease
coping
quality of life
caregiving
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2006-08-09
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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:

1. 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;
2. 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;
3. 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
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Care recipient nursing home/institutional placement
timeFrame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
measure: Caregiver emotional stress
timeFrame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
measure: caregiver depression
timeFrame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
measure: caregiver social support
timeFrame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
Secondary outcomes:
measure: Caregiver subjective health
timeFrame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
measure: secondary stressors
timeFrame: baseline, 4, 8, 12, and 18 months; 24, 30, 36 months if possible
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, School of Nursing, 6-150 Weaver-Densford Hall
state: Minnesota
city: New York
country: United States
facility: Silberstein Institute for Aging and Dementia, Department of Psychiatry, NYU School of Medicine
state: New York
Study officials:
affiliation: University of Minnesota, Center on Aging, Center for Gerontological Nursing, School of Nursing
name: Joseph E. Gaugler, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Silberstein Institute for Aging and Dementia, Department of Psychiatry, NYU School of Medicine
name: Mary Mittelman, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Gaugler 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.
citation: Gaugler 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.
citation: Gaugler 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.
citation: Gaugler 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.
citation: Albers, 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.