Partners at Meals - Respite Care and Home (PAM) (PAM)

Mealtime Partnerships for People With Dementia in Respite Centers and at Home

The goal of this study is to test the efficacy of a mealtime intervention in respite care centers for people with dementia and their caregivers. Mealtimes become more challenging as dementia progresses causing nutritional and behavioral issues in the affected individuals. Using a train-the-trainer program built on the Partners at Meals model, volunteers in respite centers partner with caregivers and develop a mealtime plan that builds on the strengths of the person with dementia, and develop a supportive environment for change. A tele-health component is involved in the communication between the respite center volunteers/staff and families. Recruitment is limited to people attending the particular respite centers.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Dementia, Alzheimer Type
• Intervention / Treatment: Behavioral: Partners at Meals; Behavioral: Enhanced Usual Condition

Detailed Description

The goal of this study is to test the efficacy of a mealtime intervention (Partners at Meals) in respite care centers (RCCs) that provide a social model of care for people with dementia living in the community and support for their caregivers. Largely staffed by long-time volunteers, these centers support caregivers' ability to maintain their loved one in the home. Traditionally, support for social activities and mealtime offered by the RCCs cannot be extended to home. In this project, we will use a telehealth interface to provide consultation to family caregivers in the context of home where problems arise.

Outcomes include improvements in: a) quality of life (QOL) and nutritional outcomes for people with dementia (PWD) and QOL outcomes for family caregivers (CGs); b) self-efficacy training outcomes for assessing and managing meals for the CGs and the RCC volunteers; and c) sustainability outcomes as determined by directors of the RCCs. Two large RCCs with a total of 5 sites of care in suburban and rural areas of SC will be the sites of this project.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Persons with Dementia (PWD): aged ≥ 60 years; attending a participating respite care center (RCC) at least once/week; living with or within the same property as caregiver (CG); diagnosis of Alzheimer's disease or related dementia with mild to moderate stage as demonstrated by the Functional Assessment Staging Scale (FAST) of 5 or greater and a MMSE of 12 or above; absence of wasting disorders (e.g., HIV/AIDS, heart or renal failure or COPD, end-stage cancer) ; some supervision required or dysfunctional behavior present (e.g., redirection)
• Caregiver (CG): lives with or on same property as the PWD; provides 4 hours or more of care/day; assists with ADLs including meals
• Volunteer: present at the RCC at least weekly (at least 4 hours/week); identify as comfortable in the teacher/coach role, and demonstrate ability to use televideo and photograph.
• Administrator: worked with the organization for at least 3 months and plans to be in place for at least 9 more months.

Exclusion Criteria:

• Persons with Dementia (PWD): not receiving enteral feeding or active treatment by a speech pathologist/therapist; not diagnosed with dysphagia as identified by caregiver or on RCC Intake Sheet. Those enrolled in or qualifying for hospice will not be included.
• Caregiver (CG); paid for services as caregiver; unable to speak or read English
• Volunteer: unable to read and speak English
• Administrator: plans to leave organization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment - Partners at Meals (PAM); People with dementia (PWD) often lose weight and suffer subsequent health issues: the goal of this intervention is to improve or maintain weight of a PWD, and to improve or maintain food intake. A train-the-trainer intervention is used with volunteers in Respite Care Centers who partner with family caregivers of PWD. Designed to be personalized to the PWD and focusing on his/her existing strengths and compensating for his/her deficits in mealtime management, sessions occur initially (1 hr) and every month (~30 mins) to reinforce key areas of behavioral or environmental change. Samsung tablets are used initially and then monthly (x5) to record mealtimes in the home, and are reviewed by the volunteer with the family member at the monthly session to discuss areas where changes could be made.	Behavioral: Partners at Meals; The focus of the intervention is to facilitate meals using knowledge of the person with dementia's past history and lifelong preferences as well as their stage of disease, altering the behavior of the caregiver at meals to ameliorate dysfunctional behaviors, and altering the environment to make it more focused on the process of meals.; Other Names: PAM
Placebo Comparator: Enhanced Usual Condition (EUC); In the non-treatment respite care centers, an Enhanced Usual Condition will be delivered to caregivers of People with Dementia (PWD). This program consists of enhanced training in caregiving using components from a module of the evidence-based Savvy Caregiver program (K. Hepburn) given in a group setting with opportunity for a question and answer period; the program is given for new enrollees and every 6 months. The PI (EJA), the nutritionist (KM) or the Program Manager (MCP) will lead these groups. Weight of the PWD is measured initially and monthly (x5); amount of food consumed will be measured using the Samsung tablets, also initially and monthly (x5).	Behavioral: Enhanced Usual Condition; Enhanced Usual Condition (EUC) Staff and volunteers at the EUC sites will receive training in communication between family and friends of the person with dementia. Following the general model of the Savvy Caregiver (Hepburn), communication training will occur every six months in these two sites. Families will be trained by project staff to record three meals including behavior at home each month. The Project Manager will attend the monthly support group for family members about communication. The administrator of the EUC RCC will be interviewed every 6 months the project is in place.; Other Names: EUC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight maintenance	Assessed by monthly weight in kilograms	up to 6 months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Teresa Kelechi, MUSC College of Nursing

Publications and helpful links

General Publications

• Amella Krug EJ, Qanungo S, Martin KL, Mueller M, Madisetti M, Kelechi TJ. 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. BMC Nutr. 2020 Jun 24;6:24. doi: 10.1186/s40795-020-00350-x. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: caregiving; respite care; mealtimes; train-the-trainer
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Body Weight; Neurodegenerative Diseases; Body Weight Changes; Tauopathies; Dementia; Weight Loss; Alzheimer Disease
• Other Study ID Numbers: Pro00064441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared with other investigators who have IRB approved studies; data will be anonymized.
• IPD Sharing Time Frame: Will be shared as approved by the MUSC IRB and from one year after the study closes to five years after the study closes or as long as the Principle Investigator(s) are employed by the University.
• IPD Sharing Access Criteria: Contact the PIs through the College of Nursing
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No