Partners at Meals - Respite Care and Home (PAM)

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT03622814

Collaborator

(none)

180

Enrollment

Location

Arms

70.5

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia, Alzheimer Type Weight Loss	Behavioral: Partners at Meals Behavioral: Enhanced Usual Condition	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (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.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 15, 2017

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Weight maintenance [up to 6 months]
Assessed by monthly weight in kilograms

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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