A cluster randomized controlled trial to assess the efficacy of a telehealth-based train-the-trainer mealtime intervention delivered by respite care center volunteers to caregivers of persons with dementia to improve nutritional outcomes and quality of life

Elaine J Amella Krug, Suparna Qanungo, Kelley L Martin, Martina Mueller, Mohan Madisetti, Teresa J Kelechi, Elaine J Amella Krug, Suparna Qanungo, Kelley L Martin, Martina Mueller, Mohan Madisetti, Teresa J Kelechi

Abstract

Background: Persons with dementia with mild to moderate cognitive impairment are at risk for developing impairments with activities of daily living such as the ability to feed oneself, that negatively influence health. Lack of caregiver skills related to mealtime planning for persons with dementia and the ability to cope with dysfunctional behaviors are well-documented factors that influence nutritional status outcomes, lead to weight loss, poor quality of life, and impact their ability to remain at home.

Methods: A cluster randomized controlled trial with a parallel mixed methods evaluation processes will be conducted to examine the efficacy of a train-the-trainer program using non-paid volunteers in respite care centers to deliver a telehealth mealtime intervention guided by the theory-based C3P Model-Change the Person, Change the People, Change the Place (C3P). In this six-month study, dyads of caregivers and persons with mild to moderate dementia receiving respite care services will be randomized to receive either the telehealth intervention or enhanced usual care. Within the intervention group, dyads will be partnered with a C3P trained volunteer who will work with caregivers via videoconference to devise and implement mealtime plans. Under usual care, dyads will receive standardized educational materials modified from The Savvy Caregiver Program for Alzheimer's disease. The primary outcomes include weight maintenance or gain of the person with dementia and quality of life of the caregiver. A multi-level evaluation process utilizing respite center administrators and directors, volunteers, and caregivers will explore intervention fidelity, acceptability and sustainability. Using both the CONSORT and SPIRIT checklists as guidance, the comprehensive study design is more fully described in this manuscript.

Discussion: In this trial, we will lay the groundwork to examine the efficacy and sustainability of a train-the-trainer telehealth program that could be widely disseminated by national Alzheimer's organizations and readily adopted by community agencies to provide additional resources to assist families in managing mealtimes at home, while promoting the quality of life of both the caregiver and the person with dementia.

Trial registration: This study was registered with clinicaltrials.gov: NCT03622814 on August 9, 2018..

Keywords: Alzheimer’s disease; Caregiver; Dementia; Nutrition; Respite care; Train-the-trainer; Weight loss.

Conflict of interest statement

Competing interestsThe authors declare that there are no competing interests with regard to this protocol or the study.

© The Author(s) 2020.

Figures

Fig. 1
Fig. 1
Diagram of the study flow

References

    1. Amella EJ, Batchelor-Aselage MB. Facilitating ADLs by caregivers of persons with dementia: the C3P model. Occup Ther Health Care. 2014;28(1):51–61. doi: 10.3109/07380577.2013.867388.
    1. Batchelor-Aselage M, Amella EJ, Rose SB, Bales CW. Handbook of Clinical Nutrition and Aging. Nutrition and Health. 3. New York, NY: Humana Press; 2015. Dementia-related mealtime difficulties: Assessment and management in long-term care; pp. 287–301.
    1. Amella EJ. Factors influencing the proportion of food consumed by nursing home residents with dementia. J Am Geriatr Soc. 1999;47:879–885. doi: 10.1111/j.1532-5415.1999.tb03849.x.
    1. Tamura BK, Masaki KH, Blanchette P. Weight loss in patients with Alzheimer’s disease. J Nutr Elder. 2007;26(3–4):21–38.
    1. Alzheimer’s Association. Adult Day Centers. [] Accessed on 13 Mar 2020.
    1. Matthews KA, Xu W, Gaglioti AH, et al. Racial and ethnic estimates of Alzheimer's disease and related dementias in the United States (2015-2060) in adults aged ≥65 years. Alzheimers Dement. 2019;15(1):17–24. doi: 10.1016/j.jalz.2018.06.3063.
    1. Sousa L, Sequeira C, Ferré-Grau C, Neves P, Lleixà-Fortuño M. Training programmes for family caregivers of people with dementia living at home: integrative review. J Clin Nurs. 2016;25(19–20):2757–2767. doi: 10.1111/jocn.13266.
    1. Wolff JL, Mulcahy J, Huang J, Roth DL, Covinsky K, Kasper JD. Family caregivers of older adults, 1999-2015: trends in characteristics, circumstances, and role-related appraisal. Gerontologist. 2018;58(6):1021–1032. doi: 10.1093/geront/gnx093.
    1. Mamhidir AG, Karlsson I, Norberg A, Mona K. Weight increase in patients with dementia, and alteration in meal routines and meal environment after integrity promoting care. J Clin Nurs. 2007;16(5):987–996. doi: 10.1111/j.1365-2702.2006.01780.x.
    1. Brookdale Foundation Group. The Brookdale Foundation Group – 60 Years. [] Accessed on 13 Mar 2020.
    1. Herke M, Fink A, Langer G, et al. Environmental and behavioural modifications for improving food and fluid intake in people with dementia. Cochrane Database Syst Rev. 2018;7(7):CD011542.
    1. Bronfenbrenner U, Evans G. Developmental science in the 21st century: emerging questions, theoretical models, research designs and empirical findings. Soc Dev. 2000;9(1):115–125. doi: 10.1111/1467-9507.00114.
    1. Teerenstra S, Moerbeek M, van Achterberg T, Pelzer BJ, Borm GF. Sample size calculations for 3-level cluster randomized trials. Clin Trials. 2008;5(5):486–495. doi: 10.1177/1740774508096476.
    1. Hepburn K, Lewis M, Tornatore J, Sherman CW, Bremer KL. The savvy caregiver program: the demonstrated effectiveness of a transportable dementia caregiver psychoeducation program. J Gerontol Nurs. 2007;33(3):30–36. doi: 10.3928/00989134-20070301-06.
    1. McCulloch CE, Searle SR. Generalized, linear, and mixed models. New York: Wiley; 2001. pp. 281–284.
    1. Hedeker D, Mermelstein RJ, Demirtas H. Analysis of binary outcomes with missing data: missing = smoking, last observation carried forward, and a little multiple imputation. Addiction. 2007;102(10):1564–1573. doi: 10.1111/j.1360-0443.2007.01946.x.
    1. Fitzmaurice GM, Laird NM, Ware JH. Applied Longitudinal Analysis 2nd ed. Hoboken NJ: Wiley; 2011.
    1. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89:1322–1327. doi: 10.2105/AJPH.89.9.1322.

Source: PubMed

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