Partners at Meals - Respite Care and Home (PAM) (PAM)
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|ClinicalTrials.gov Identifier: NCT03622814|
Recruitment Status : Active, not recruiting
First Posted : August 9, 2018
Last Update Posted : August 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dementia, Alzheimer Type Weight Loss||Behavioral: Partners at Meals Behavioral: Enhanced Usual Condition||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|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.|
|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 :||August 15, 2017|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
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 Name: 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 Name: EUC
- Weight maintenance [ Time Frame: up to 6 months ]Assessed by monthly weight in kilograms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622814
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Teresa Kelechi||MUSC College of Nursing|