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

Primary Purpose

Dementia, Alzheimer Type, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Partners at Meals
Enhanced Usual Condition
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia, Alzheimer Type focused on measuring caregiving, mealtimes, respite care, train-the-trainer

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment - Partners at Meals (PAM)

Enhanced Usual Condition (EUC)

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Weight maintenance
Assessed by monthly weight in kilograms

Secondary Outcome Measures

Full Information

First Posted
May 3, 2018
Last Updated
July 21, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03622814
Brief Title
Partners at Meals - Respite Care and Home (PAM)
Acronym
PAM
Official Title
Mealtime Partnerships for People With Dementia in Respite Centers and at Home
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Type, Weight Loss
Keywords
caregiving, mealtimes, respite care, train-the-trainer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized cluster-design trial will be conducted in two large respite care centers (RCCs) with five sites that serve primarily white and African American persons with dementia. RCCs will be randomized to the intervention condition (Partners at Meals; 3 sites) or ['enhanced usual care' (EUC)] (2 sites). The primary unit of analysis is the person with dementia (PWD) and caregiver (CG): 60 PWDs, 60 CGs will be enrolled; it is estimated that up to 60 volunteers/staff/managers may be enrolled. The caregivers and RCC volunteer is another dyad for analysis, as is the RCC volunteer and the PWD. Additionally, RCC Managers at both PaM and EUC sites will be interviewed regarding barriers to implementation, ways to enhance the project, and possible causes of discharge of PWD from the study related to nutritional problems.
Masking
Participant
Masking Description
Participants will not know if they are in a site that is receiving the treatment or in the usual condition site. Randomization is by site, not by individuals.
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment - Partners at Meals (PAM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Condition (EUC)
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Partners at Meals
Other Intervention Name(s)
PAM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Condition
Other Intervention Name(s)
EUC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight maintenance
Description
Assessed by monthly weight in kilograms
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Kelechi
Organizational Affiliation
MUSC College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
32587748
Citation
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.
Results Reference
derived

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Partners at Meals - Respite Care and Home (PAM)

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