Skip to main content
OpenTrials
Completed

NCT Number: NCT00259454

Project COPE:Managing Dementia at Home

This study tests the effectiveness of an in-home intervention to reduce upset and burden among family caregivers, and decrease nursing home placement. The main hypothesis that will be tested is that compared to control group, subjects, experimental group participants will have enhanced well-being and fewer nursing home placements.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

Implement a multi-component in-home intervention designed to prevent and ameliorate the troublesome behaviors that families typically confront and that often trigger nursing home placement. The intervention combines the most effective strategies that have been identified in previous caregiver research by the investigative team and best clinical practices to provide a comprehensive service approach to families and individuals with dementia including education, skills training, home safety, and stress management. To enhance its applicability to real-world practice within the aging service network, the intervention is designed to be reproducible and its components and treatment goals commensurate with the Medicaid Waiver Program. In the absence of evidence-based service protocols currently in place for this Waiver population, the intervention, if effective, would provide a systematic, evidence-based approach in the Medicaid Waiver program to help families and persons with dementia remain at home and in their communities.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Care-recipients must have a MMSE score < 24 and a diagnosis of dementia, live in the community, and either need help with one or more daily activities and/or have one or more behavioral occurrences. Caregivers must be a relative, at least 21 years of age, be English speaking, have a telephone, either live with the care-recipient (CR) or spend at least 48 hours per week in direct oversight or caring for him/her; plan to live in the area for 9 months, report upset with CR function dependence or behavioral occurrences.

Exclusion criteria

  • The CG-CR dyad will be excluded if CR has had more than 3 hospitalizations within the past 12 months, are in treatment for life-threatening cancer, have schizophrenia or a bipolar disorder, have dementia secondary to head trauma, have a MMSE score = 0 and are bed-bound (defined as confinement to bed or chair for at least 22 hours a day for at least four of the previous seven days); or they are enrolled in a clinical trial of pharmacological treatment for agitation. Also, the dyad will be excluded if the CG had more than 3 hospitalizations within the past 12 months or is in treatment for life-threatening cancer; is involved in another clinical trial of psychosocial or educational interventions for caregivers; or plans to place their family member in a nursing home within the next 9-months.

Treatment and study plan

In-home intervention

Behavioral

occupational therapy techniques to reduce caregiver stress

Primary outcomes

  1. ADL/IADL

    Time frame: Baseline, t2, t3

  2. Caregiver upset

    Time frame: Baseline, t2, t3

  3. Caregiver confidence

    Time frame: when needed

  4. Behaviors

    Time frame: Baseline, t2, t3

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Pennsylvania Department of Health

Registry information

Official study title

Managing Problem Behaviors of Alzheimer's Disease

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Nov 29, 2005
Registry last updated
Mar 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.