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Alzheimer's DiseasePhase 3NCT00259480

Project ACT: Advancing Caregiving Techniques

A Phase 3 study testing Home Based Intervention in people with Alzheimer's Disease, run by Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease
What is being tested?
Home Based Intervention
How many people
272 participants
Where
1 siteUnited States
Study dates
Aug 2001to Mar 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Laura N. Gitlin,Ph.D

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: 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).

Being tested
Home Based Intervention
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home Based InterventionBehavioural

    occupational therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Caregiver upset

    Measured: Baseline, t2, t3

  2. Care recipient behaviors

    Measured: Baseline, t2, t3

Secondary outcomes (3)

  1. Caregiver self-efficacy

    Measured: Baseline, t2, t3

  2. Nursing home placement

    Measured: When needed

  3. Caregiver depression

    Measured: Baseline, t2, t3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2005 (estimated)
  2. Study startAug 2001
  3. Primary completionMar 2014
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Investigator
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00259480
Sponsor's protocol ID
R01AG022254
Status last verified
May 2015
First submitted
28 Nov 2005
Last updated
13 May 2015
Results posted
No

Publications

  • 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.

    PubMed 33571930

  • 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.

    PubMed 30556172

  • 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.

    PubMed 28260539

  • 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.

    PubMed 26833933

  • 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.

    PubMed 20921879

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Home Based Intervention in people with Alzheimer's Disease, run by Thomas Jefferson University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregiver upset (time frame: Baseline, t2, t3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00259480, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.

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Project ACT: Advancing Caregiving Techniques | AzTrials