Buffalo, New York 14214

  • Function


This randomized control study is to test effectiveness of occupational therapy support for informal caregivers of older adults with cognitive decline. Care recipients are community-living older adults who are eligible for a nursing home level of care. At baseline challenges that caregivers are facing will be expressed and individualized solutions will be identified and delivered for the treatment and educational material will be given to the control group. Two and four months later, follow up interview will be made to identify changes in burden, depression, fatigue, self-efficacy, and positive aspect of care giving. It is expected to show when the effectiveness becomes clear.

Study summary:

Family caregivers of frail older adults with cognitive impairments face special challenges in caring for their care recipients (CR) due to their fast declining health. Examples of difficulties include managing CR's behaviors and daily activities, as well as maintaining their own psychological and physical health, which result in high caregiver burden. The aim is to support these caregivers of older adults who are enrollees of the Program for All-inclusive Care for the Elderly (PACE) through occupational therapy (OT) interventions to reduce caregiver burden and depression, and increase positive aspects of caregiving and self-efficacy. Since PACE organizations offer limited support for caregivers due to understanding, supervised OT graduate students (OTGS) will provide caregivers with customized supports. By doing so, the students will gain precious experience before they enter the workforce. This proposal will develop and test the effectiveness of this collaborative model. This study will use a randomized controlled design with about a 4- month intervention period. The assessments will take place at baseline, 2 months and 4 months. The study period will be two years. Participants will be 60 convenience family caregivers of the PACE enrollees in Western New York; therefore, CRs are 55 years old or older, need a nursing home level of care, but remain living in the community. Caregivers are adults who visit the CR at least once a week. OTGS will contact the caregivers, using a phone, and conduct an in depth interview to understand their difficulties. Then solutions will be brainstormed amongst OTs and geriatric specialists, and interventions will be formed. At the first visit to the CRs' homes, interviews will be conducted using the Zarit Burden Interview, the Center for Epidemiology Study for Depression, the Buffalo Fatigue Scale, the Positive Aspect of Caregiving, and the Visual Analogue Scale for self-efficacy. The possible solutions will be discussed with caregivers and more detailed difficulties will be videotaped. The solutions that caregivers are comfortable with will be reviewed by the PACE Rehabilitation Department and need to be approved before their implementation. The solutions may include: education of disease process, training for caregivers in supporting CR's activities of daily living (ADL) and instrumental ADL, coordination of family caregivers, problematic behaviors, functional exercise, fall prevention, and increased number of CR's visits to a PACE daycare facility. Statistical analysis will use Generalized Estimating Equations to compare the two groups' linear trends. We expect CRs' condition will deteriorate but the treatment group will reduce caregiver burden and increase self-efficacy.


Inclusion Criteria: - • Caregivers of community-dwelling older adults (55 and over) who are member of the PACE - Adult 21 years or older - Living with the care recipient or within a distance so that they can visit him/her minimum once a week - Cognitively intact (can recall three words immediately and 3 minutes later) - Competent in English Exclusion Criteria: - One instrument (Positive aspect of caregiving) is only available in English. To fully understand caregivers' challenges and convey solutions, our current study OT graduate students are not competent enough in other languages to provide interventions. We do not have budget to hire interpreters.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

Support for Caregivers of Older Adults With Cognitive Decline

Official Title:

Providing Support to Caregivers of Frail Older Adults With Cognitive Impairments

Overall Status:


Study Phase:




Minimum Age:

21 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

State University of New York at Buffalo

Oversight Authority:

There was an error processing this request

Reasons Why Stopped:

Study Type:


Study Design:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Machiko R Tomita, Ph.D.
Principal Investigator
State University of New York at Buffalo

Study Dates

Start Date:January 19, 2018
Completion Date:May 31, 2020
Completion Type:Actual
Primary Completion Date:October 2, 2019
Primary Completion Type:Actual
Verification Date:March 2021
Last Changed Date:March 3, 2021
First Received Date:February 25, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in caregiver burden measured by the Zarit Burden Interview
Time Frame:4 months
Safety Issues:False
Description:To measure changes in burden of care using the 22-item Zarit Burden Interview (ZBI). Each item is rated from Never (0), Rarely (1), Sometimes (2), Quite Frequently (3), to Nearly Always (4). Higher scores indicate higher burden. The ZBI is scored by addin
Outcome Type:Primary Outcome
Measure:Change in depression change measured by the Center for Epidemiology Studies-Depression
Time Frame:4 months
Safety Issues:False
Description:To measure changes in depression using the Center for Epidemiology Studies -Depression (CES-D). This scale asks how often a respondent experienced symptoms associated with depression within the past week. The scale is scored from 0 to 3, with 0 representi
Outcome Type:Primary Outcome
Measure:Change in confidence to continue caring for the care recipient in the future (6 months)
Time Frame:4 months
Safety Issues:False
Description:To measure changes in confidence to confine caring for the care recipient using Visual Analogue Scale. It asks caregivers to rate their confidence on a scale of 1 to 10 on Visual Analogue Scale. This assessment asked the caregivers to rate themselves rega
Outcome Type:Secondary Outcome
Measure:Change in a cognitive level of care recipients measured by the Global Deterioration Scale
Time Frame:4 months
Safety Issues:False
Description:To measure changes in cognition using the Global Deterioration Scale (GDS). The GDS consists of levels 1 to 7. Level 1 indicates "no cognitive decline," Level 2, "very mild cognitive decline/ age associated memory impairment," Level 3, "mild cognitive dec
Outcome Type:Secondary Outcome
Measure:Change in instrumental activities of daily living (IADL) of care recipients measured by IADL from the Older Americans Resources and Services
Time Frame:4 months
Safety Issues:False
Description:To measure changes in IADL using questionnaires in the Older Americans Resources and Services (OARS) Multidimensional Functional Assessment. The IADL has seven items: using a phone, getting to places out of walking distance, shopping for groceries or clot

Study Interventions

Intervention Type:Behavioral
Name:Occupational Therapy support
Description:Intervention include (a) didactic education about diseases; (b) the use of errorless techniques to improve assistance for CR's Activities of Daily Living (ADL), Instrumental ADL, and communication tasks; (c) the use of incentives (e.g., providing a favorite scented shampoo); (e) use of a schedule/calendar on a computer, cell phone and/or blackboard in CR's home to coordinate caregiving tasks for family members; (f) suggesting more frequent PACE daycare visits or use of a nearby PACE, having a sn
Arm Name:Treatment group

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment group
Description:Intervention is occupational therapy support
Study Arm Type:No Intervention
Arm Name:Control group
Description:No intervention was provided, only educational material was given.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:State University of New York at Buffalo
Agency Class:Other
Agency Type:Collaborator
Agency Name:Ralph C. Wilson Jr. Foundation (Funding source)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Pinquart M, Sörensen S. Correlates of physical health of informal caregivers: a meta-analysis. J Gerontol B Psychol Sci Soc Sci. 2007 Mar;62(2):P126-37.
Reference Type:Results Reference
Citation:Beinart N, Weinman J, Wade D, Brady R. Caregiver burden and psychoeducational interventions in Alzheimer's disease: a review. Dement Geriatr Cogn Dis Extra. 2012 Jan;2(1):638-48. doi: 10.1159/000345777. Epub 2012 Dec 15.
Reference Type:Results Reference
Citation:Austrom MG, Lu Y. Long term caregiving: helping families of persons with mild cognitive impairment cope. Curr Alzheimer Res. 2009 Aug;6(4):392-8.
Reference Type:Results Reference
Citation:Dean K, Wilcock G. Living with mild cognitive impairment: the patient's and carer's experience. Int Psychogeriatr. 2012 Jun;24(6):871-81. doi: 10.1017/S104161021100264X. Epub 2012 Jan 17. Review.
Reference Type:Results Reference
Citation:Etters L, Goodall D, Harrison BE. Caregiver burden among dementia patient caregivers: a review of the literature. J Am Acad Nurse Pract. 2008 Aug;20(8):423-8. doi: 10.1111/j.1745-7599.2008.00342.x. Review.
Reference Type:Reference
Citation:Reisberg B, Sclan SG, Franssen E, Kluger A, Ferris S. Dementia staging in chronic care populations. Alzheimer Dis Assoc Disord. 1994;8 Suppl 1:S188-205. Review.
Reference Type:Reference
Citation:González P, Nuñez A, Merz E, Brintz C, Weitzman O, Navas EL, Camacho A, Buelna C, Penedo FJ, Wassertheil-Smoller S, Perreira K, Isasi CR, Choca J, Talavera GA, Gallo LC. Measurement properties of the Center for Epidemiologic Studies Depression Scale (CES-D 10): Findings from HCHS/SOL. Psychol Assess. 2017 Apr;29(4):372-381. doi: 10.1037/pas0000330. Epub 2016 Jun 13.
Reference Type:Reference
Citation:Ottenbacher KJ, Mann WC, Granger CV, Tomita M, Hurren D, Charvat B. Inter-rater agreement and stability of functional assessment in the community-based elderly. Arch Phys Med Rehabil. 1994 Dec;75(12):1297-301.
Reference Type:Reference
Citation:Seeher K, Low LF, Reppermund S, Brodaty H. Predictors and outcomes for caregivers of people with mild cognitive impairment: a systematic literature review. Alzheimers Dement. 2013 May;9(3):346-55. doi: 10.1016/j.jalz.2012.01.012. Epub 2012 Nov 2. Review.

Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

This study is not currently recruiting Study Participants. The form below is not enabled.