Support for Caregivers of Older Adults With Cognitive Decline

NCT ID: NCT04787068

Last Updated: 2021-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-19
• Study Completion Date: 2020-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Caregiver Burden; Depression; Confidence, Self; Cognition; Fatigue; Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Treatment group

Intervention is occupational therapy support

Group Type: EXPERIMENTAL

Occupational Therapy support

Intervention Type: BEHAVIORAL

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 snack or short game to prevent going to bed right after dinner); (d) use of the Buffalo Functional Exercise for strengthening ( a home-based exercise developed for PACE by the PI and shown to be effective in preventing falls)

Control group

No intervention was provided, only educational material was given.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Occupational Therapy support

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 snack or short game to prevent going to bed right after dinner); (d) use of the Buffalo Functional Exercise for strengthening ( a home-based exercise developed for PACE by the PI and shown to be effective in preventing falls)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ralph C. Wilson Jr. Foundation (Funding source)

UNKNOWN

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Machiko R Tomita

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Machiko R Tomita, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

State University of New York at Buffalo

Locations

State University of New York

Buffalo, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23123229 (View on PubMed)

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: BACKGROUND

PMID: 7993167 (View on PubMed)

Gonzalez P, Nunez 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: BACKGROUND

PMID: 27295022 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 8068258 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18786017 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22251799 (View on PubMed)

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. doi: 10.2174/156720509788929291.

Reference Type: RESULT

PMID: 19689239 (View on PubMed)

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: RESULT

PMID: 23341829 (View on PubMed)

Pinquart M, Sorensen S. Correlates of physical health of informal caregivers: a meta-analysis. J Gerontol B Psychol Sci Soc Sci. 2007 Mar;62(2):P126-37. doi: 10.1093/geronb/62.2.p126.

Reference Type: RESULT

PMID: 17379673 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/18786017

Identified current evidence of factors influencing dementia-related caregiver burden

http://www.ncbi.nlm.nih.gov/pubmed/22251799

MCI results in significant challenges for both patients and their carers. Further work is required in order to establish the best way to help patients and carers meet these challenges

https://www.ncbi.nlm.nih.gov/pubmed/19689239

Describe common psychological and caregiving issues that can cause stress in family members of persons with mild cognitive impairment (PwMCI) in order to assist family members in providing care and support to the PwMCI while also caring for themselves ov

https://www.ncbi.nlm.nih.gov/pubmed/23341829

Interventions that are individually tailored to the caregiver are particularly effective at reducing caregiver burden and should be further investigated

https://www.ncbi.nlm.nih.gov/pubmed/17379673

negative effects of caregiving on physical health are most likely to be found in psychologically distressed caregivers facing dementia-related stressors.

https://www.ncbi.nlm.nih.gov/pubmed/23123229

Depression and psychological comorbidity, although not as pronounced as in dementia caregivers, are common complications in MCI caregivers

http://connect.springerpub.com/content/sgrjnm/25/3/476

Reliability and Validity of the Center for Epidemiologic Studies Depression Scale in a Population-Based Cohort of Middle-Aged U.S. Adults

Other Identifiers

STUDY00001647

Identifier Type: -

Identifier Source: org_study_id