Project ACT: Advancing Caregiving Techniques

May 12, 2015 updated by: Thomas Jefferson University

Reducing Family Caregiver Upset With Disruptive Behavior

The specific aims of this study are to:

  1. Test the immediate effectiveness of the intervention to reduce caregiver upset with targeted disruptive behaviors (primary outcome). Hypothesis: Caregivers in the intervention group will report less upset with target behaviors at 4-months in comparison to caregivers in the control group.
  2. Test the immediate effectiveness of the intervention to reduce caregiver burden (secondary outcome). Hypothesis: Caregivers in the intervention group will report less burden at 4-months in comparison to caregivers in the control group.
  3. Test the immediate effectiveness of the intervention to reduce the frequency of occurrence of targeted disruptive behaviors in persons with dementia (secondary outcome). Hypothesis: Caregivers in the intervention group will report a decrease in the frequency of occurrence of targeted behaviors at 4-months in comparison to caregivers in the control group.
  4. Test the maintenance effect of intervention at 6-months on caregiver upset and burden and targeted disruptive behaviors. Hypothesis: Compared to usual care, caregivers in intervention will maintain reduced upset and burden and report less occurrences of targeted behaviors from 4 to 6-months.
  5. Assess the cost of the intervention and its cost effectiveness.

We have also received funding to conduct a supplementary study to evaluate the effect of the nurse intervention on behavior reduction and caregiver distress. The specific aims of this supplementary study arm are to: 1) describe the prevalence and type of medical conditions among control group participants who receive the nurse intervention, 2) describe for those with a detected medical condition/problem, the number of caregivers who follow-up with physicians and the type of physician follow-up/treatment that occurs; 3) evaluate whether control group participants who receive the nurse intervention report reduced disruptive behaviors and caregiver upset at 6 weeks (pre-post comparison); and 4) for control group participants who receive the nurse intervention, compare the level of disruptive behaviors and caregiver upset 4 months from entry into this study arm with the results in the Project ACT experimental group (who received the multi-component intervention).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Laura N. Gitlin,Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Caregivers are eligible for study participation if they:

    • are a family member 21 years of age or older (male or female),
    • live with the care recipient,
    • able to participate in the interview in English
    • have a telephone in their home,
    • plan to live in the area for 6 months, and
    • report a high level of upset with behaviors as follows. We will use the Agitated Behavior in Dementia Scale (ABID),62 which is a 16-item psychometrically valid scale of behavioral occurrences and associated caregiver upset. We chose this scale out of the six primary scales used to measure behavior given that the behaviors most closely match the intent of the intervention we plan to test. The behaviors include those listed earlier plus one additional behavior, repetitive vocalization. For each of these 17 behaviors that occur in the past week (for the purposes of screening eligibility, we will use a yes/no response format), caregivers are asked their level of upset (0 = not at all, 1 = a little, 2 = moderately, 3 = very much and 4 = extremely).

  • Caregivers will be considered eligible if they obtain a total summed score of "3" or higher using the following algorithm:

    • Caregivers must report at least one behavior as very ("3") or extremely ("4") upset, or
    • caregivers must report three or more behaviors in which one behavior causes at least moderate ("2") level upset and one behavior causes at least a little upset.

Thus, caregivers with only scores of "1" ( a little upset) with three or more behavioral occurrences will not be considered eligible for this study. That is, this criteria excludes caregivers with no upset or a little upset. We will also require that the care recipient: 1) has a NINCDS-ADRDA diagnosis (physician generated) of dementia or a Mini-mental State Examination (MMSE) score of <23.

Exclusion Criteria:

  • A caregiver is excluded if the caregiver or care recipient:

    • has a terminal illness with life expectancy < 6 months,
    • is in active treatment for cancer, or
    • has had >3 acute medical hospitalizations in the past year.

  • Caregivers will also be excluded if:

    • they are currently involved in another clinical trial of psychosocial or educational interventions for caregivers; or
    • they are planning to place their family member in a nursing home within the next 6-months.

  • Care-recipients will also be excluded if:

    • they have schizophrenia or a bi-polar disorder,
    • their dementia is secondary to probable head trauma,
    • their MMSE score = 0 and they are considered 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,
    • a nursing home admission is planned to occur within six months or
    • they are enrolled in a clinical trial of pharmacological treatment for agitation.

These criteria exclude caregivers of ADRD patients at the severe stage of the disease process who may not benefit from the proposed intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Caregiver upset
Time Frame: Baseline, t2, t3
Baseline, t2, t3
Care recipient behaviors
Time Frame: Baseline, t2, t3
Baseline, t2, t3

Secondary Outcome Measures

Outcome Measure
Time Frame
Caregiver self-efficacy
Time Frame: Baseline, t2, t3
Baseline, t2, t3
Nursing home placement
Time Frame: When needed
When needed
Caregiver depression
Time Frame: Baseline, t2, t3
Baseline, t2, t3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Laura N Gitlin, Ph.D, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

November 28, 2005

First Submitted That Met QC Criteria

November 28, 2005

First Posted (Estimate)

November 29, 2005

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 12, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AG022254 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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