Trial Outcomes & Findings for Partners at Meals - Respite Care and Home (PAM) (NCT NCT03622814)

NCT ID: NCT03622814

Last Updated: 2025-04-10

Results Overview

Assessed by unit of measure in pounds; reported as mean difference in pounds from baseline to follow-up at 6 months

Recruitment status

COMPLETED

Study phase

Target enrollment

106 participants

Primary outcome timeframe

This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.

Results posted on

2025-04-10

Participant Flow

Using a cluster randomized controlled experimental design based on each Respite Care Center's (RCCs; N=6) respective average monthly client census, RCCs were randomized to either the Partners at Mealtime (PAM) intervention (N=3; RCCs) or the control enhanced usual care (EUC) group (N=3; RCCs). Enrolled PWD/CG dyads were then allocated to the PAM intervention or the enhanced usual care (EUC) control groups based upon their RCC of attendance.

Unit of analysis: clinical sites

Participant milestones

Participant milestones
Measure	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. 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.	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 (TK), 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). 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.
Overall Study STARTED	54 3	52 3
Overall Study PWD	27 3	21 3
Overall Study Caregiver	27 3	21 3
Overall Study COMPLETED	46 3	38 3
Overall Study NOT COMPLETED	8 0	14 0

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.	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 (TK), 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). 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.
Overall Study Lost to Follow-up	8	14

Baseline Characteristics

The overall number of baseline participants includes both caregivers and persons with dementia combined.