Support for Caregivers of Older Adults With Cognitive Decline

NCT04787068 | Completed

• 1 other identifier: STUDY00001647
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Informal caregivers; Intervention

Outcome Measures

Primary Outcomes (3)

• Change in caregiver burden measured by the Zarit Burden Interview

  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 adding up the responses of all items, ranging from 0 to 88. The interpretations of scores are: 0-20 (no burden), 21-40 (mild to moderate burden), 41-60 (moderate to severe burden), and 61-88 (severe burden). The ZBI has good internal consistency reliability and good validity, and scores were significantly positively correlated with behavior problems in the care recipients and depression scores of the caregivers, according to the study using caregivers (Herbert et al, 2000).

  4 months

• Change in depression change measured by the Center for Epidemiology Studies-Depression

  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 representing rarely or none of the time (less than one day), 1 representing some or a little of the time (1 to 2 days), 2 representing occasionally or a moderate amount of time (3 to 4 days), or 3 representing most or all of the time (5 to 7 days). Total scores could range from 0 (the lowest depression score) to 60 (the highest). A score of 16 or higher indicates a depressive symptom. The CES-D has high internal consistency (Cronbach's alpha =.90) (Cosco et al., 2017), and moderate test-retest reliability (the strongest occurring whiten one to three weeks of time), as well as good measurement validity (Gonzalez et al, 2016).

  4 months

• Change in confidence to continue caring for the care recipient in the future (6 months)

  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 regarding their confidence in in caring for the care recipient in six months. A score of 1 represents no confidence, 5, mid-level confidence, and 10 represents completely confidence.

  4 months

Secondary Outcomes (2)

• Change in a cognitive level of care recipients measured by the Global Deterioration Scale

  4 months

• Change in instrumental activities of daily living (IADL) of care recipients measured by IADL from the Older Americans Resources and Services

  4 months

Study Arms (2)

Treatment group

EXPERIMENTAL

Intervention is occupational therapy support

Behavioral: Occupational Therapy support

Control group

NO INTERVENTION

No intervention was provided, only educational material was given.

Interventions

Occupational Therapy support 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)

Treatment group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Ralph C. Wilson Jr. Foundation (Funding source): collaborator

Study Sites (1)

State University of New York

Buffalo, New York, 14214, United States

Location

Related Publications (9)

• 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.

  PMID: 23123229 BACKGROUND

• 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.

  PMID: 7993167 BACKGROUND

• 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.

  PMID: 27295022 BACKGROUND

• 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.

  PMID: 8068258 BACKGROUND

• 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.

  PMID: 18786017 RESULT

• 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.

  PMID: 22251799 RESULT

• 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.

  PMID: 19689239 RESULT

• 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.

  PMID: 23341829 RESULT

• 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.

  PMID: 17379673 RESULT

Related Links

• Identified current evidence of factors influencing dementia-related caregiver burden
• 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
• 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
• Interventions that are individually tailored to the caregiver are particularly effective at reducing caregiver burden and should be further investigated
• negative effects of caregiving on physical health are most likely to be found in psychologically distressed caregivers facing dementia-related stressors.
• Depression and psychological comorbidity, although not as pronounced as in dementia caregivers, are common complications in MCI caregivers
• Reliability and Validity of the Center for Epidemiologic Studies Depression Scale in a Population-Based Cohort of Middle-Aged U.S. Adults

MeSH Terms

Conditions

Caregiver Burden; Depression; Fatigue

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Machiko R Tomita, Ph.D.

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Experimental study

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 8, 2021
• Study Start: January 19, 2018
• Primary Completion: October 2, 2019
• Study Completion: May 31, 2020
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

US (1)