Project ACT: Advancing Caregiving Techniques

NCT00259480 | Completed Phase 3

• 1 other identifier: R01AG022254
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aims of this study are to:

1. 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. 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. 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. 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. 5.Assess the cost of the intervention and its cost effectiveness.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Caregiver upset

  Baseline, t2, t3

• Care recipient behaviors

  Baseline, t2, t3

Secondary Outcomes (3)

• Caregiver self-efficacy

  Baseline, t2, t3

• Nursing home placement

  When needed

• Caregiver depression

  Baseline, t2, t3

Interventions

Home Based Intervention BEHAVIORAL

occupational therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Laura N. Gitlin,Ph.D

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (5)

• Regier NG, Taylor JL, Szanton SL, Parmelee PA, Perrin N, Liu M, Jenkins E, Hodgson NA, Gitlin LN. Pain in persons with dementia and the direct and indirect impacts on caregiver burden. Geriatr Nurs. 2021 Mar-Apr;42(2):366-371. doi: 10.1016/j.gerinurse.2021.01.007. Epub 2021 Feb 8.

  PMID: 33571930 DERIVED

• Leggett AN, Kales HC, Gitlin LN. Finding fault: Criticism as a care management strategy and its impact on outcomes for dementia caregivers. Int J Geriatr Psychiatry. 2019 Apr;34(4):571-577. doi: 10.1002/gps.5052. Epub 2019 Jan 3.

  PMID: 30556172 DERIVED

• Rose KC, Gitlin LN. Background characteristics and treatment-related factors associated with treatment success or failure in a non-pharmacological intervention for dementia caregivers. Int Psychogeriatr. 2017 Jun;29(6):1005-1014. doi: 10.1017/S1041610217000205. Epub 2017 Mar 6.

  PMID: 28260539 DERIVED

• Gitlin LN, Rose K. Impact of caregiver readiness on outcomes of a nonpharmacological intervention to address behavioral symptoms in persons with dementia. Int J Geriatr Psychiatry. 2016 Sep;31(9):1056-63. doi: 10.1002/gps.4422. Epub 2016 Feb 2.

  PMID: 26833933 DERIVED

• Hodgson NA, Gitlin LN, Winter L, Czekanski K. Undiagnosed illness and neuropsychiatric behaviors in community residing older adults with dementia. Alzheimer Dis Assoc Disord. 2011 Apr-Jun;25(2):109-15. doi: 10.1097/WAD.0b013e3181f8520a.

  PMID: 20921879 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Laura N Gitlin, Ph.D

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2005
• First Posted: November 29, 2005
• Study Start: August 1, 2001
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

US (1)