An Innovative Psychosocial Intervention for Adult-Child Caregivers of Parents With Alzheimer's Disease

NCT ID: NCT00409279

Last Updated: 2008-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2008-04-30

Brief Summary

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The goal of this project is to test an intervention designed to reduce the incidence and magnitude of the negative effects, specifically stress, anxiety, and depression, frequently experienced by adult children who are caregivers of a parent with Alzheimer's disease (AD).

Detailed Description

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Caring for an elderly parent is a growing societal problem, and many studies have shown that caring for a person with dementia can have a negative impact on a caregiver's psychological and physical health, social life and career, and relationship with the patient. Stress and coping models proposed in the AD caregiving literature, and general stress and coping theories suggest that by improving caregivers' ability to cope and master the caregiving situation, it is possible to avoid or ameliorate the negative emotional consequences of caregiving.

Building upon the results of a pilot study, this study will formally test the efficacy of a psychosocial intervention, based on a concept of caregiving that builds on the interests, activities, and responsibilities of both the caregiver and patient in creating a care strategy. The intervention is designed to reduce the negative effects frequently experienced by adult children who care for a parent in the middle stage of Alzheimer's disease. Caregivers will learn to engage with their parents in activities that are within the patients' remaining functional and cognitive abilities. Caregivers will also be encouraged to teach activities to other family members and paid caregivers. The study will also evaluate a lower level of intervention, based on written materials.

It is expected that by increasing knowledge about AD and providing what may be a new conceptual approach to relating to a parent at this point in the disease process, 1) caregivers and patients may experience a higher level of satisfaction and gratification from their interactions, 2) caregivers will gain a sense of control and mastery over a difficult situation and thus feel more capable of coping and 3) the patient may maintain a higher level of functioning.

A randomized treatment/control design will be used, and adult-child caregivers who participate will be assigned to one of the two levels of intervention, each designed to reduce stress, anxiety and depression. The benefits of each intervention will be evaluated by looking at the change in scores on widely used measures of the anticipated outcomes among caregivers in each group, and their relative benefits will be tested by comparing scores of the caregivers in the two groups at two follow-up points, six and nine months after baseline.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

multi-component psychosocial intervention

Group Type EXPERIMENTAL

Information, counseling and support

Intervention Type BEHAVIORAL

individual-family consultation, support group, and ad hoc consultation

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Information, counseling and support

individual-family consultation, support group, and ad hoc consultation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Men or women between the ages of 21 and 90
* Adult-child caring for at least one parent who has been diagnosed with Alzheimer's disease and is in the moderate stage
* Person with Alzheimer's disease must be living at home or in a congregate residential setting that is like a home
* Caregiver must be willing to complete intake and follow-up questionnaires
* Caregiver must be willing to attend 2 workshops and 1 individual counseling session

Exclusion Criteria

* Severe psychological or physical illness
* Unwillingness to participate in all aspects of the study
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Jacob and Valeria Langeloth Foundation

OTHER

Sponsor Role lead

Responsible Party

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University of Minnesota, School of Nursing

Principal Investigators

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Mary S. Mittelman, DrPH

Role: PRINCIPAL_INVESTIGATOR

NYU School of Medicine

Locations

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Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Olanta Barton

Role: CONTACT

212-263-5710

Facility Contacts

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Olanta Barton

Role: primary

212-263-5710

References

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Mittelman MS, Ferris SH, Shulman E, Steinberg G, Ambinder A, Mackell JA, Cohen J. A comprehensive support program: effect on depression in spouse-caregivers of AD patients. Gerontologist. 1995 Dec;35(6):792-802. doi: 10.1093/geront/35.6.792.

Reference Type BACKGROUND
PMID: 8557206 (View on PubMed)

Mittelman MS, Ferris SH, Shulman E, Steinberg G, Levin B. A family intervention to delay nursing home placement of patients with Alzheimer disease. A randomized controlled trial. JAMA. 1996 Dec 4;276(21):1725-31.

Reference Type BACKGROUND
PMID: 8940320 (View on PubMed)

Other Identifiers

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Project #195

Identifier Type: -

Identifier Source: secondary_id

IA0097

Identifier Type: -

Identifier Source: org_study_id

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