Partners at Meals - Respite Care and Home (PAM)

NCT03622814 | Completed Results DMC

• 1 other identifier: Pro00064441
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study was 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 worked with caregivers and developed a mealtime plan that builds on the strengths of the person with dementia (PWD), and developed a supportive environment for change. A tele-health component was involved in the communication between the respite center volunteers/staff and families. Recruitment was limited to people attending the particular respite centers. Two large RCCs with a total of 5 sites of care in suburban and rural areas of SC were the sites of this project.

Conditions

Dementia, Alzheimer Type; Weight Loss

Keywords

caregiving; mealtimes; respite care; train-the-trainer

Outcome Measures

Primary Outcomes (5)

• Monthly Weight in Pounds on a Scale for Person With Dementia

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

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

• Person With Dementia: Dysfunctional Behavior at Meals Measured With the Edinburgh Feeding in Dementia Scale (EdFED)

  The Edinburgh Feeding in Dementia Scale (EdFED) is an observational instrument used across settings to evaluate feeding problem behavior. Using Guttmann Scaling, the EdFED Q has 4 items that measure level of assistance and 6 behavioral descriptors of specific mealtime behaviors; all are each rated 'never, sometimes, often' and cannot be rated 0, 1, 2, respectively, producing a range of 0-20 with higher scores indicating more problem behaviors. The instrument was used to also assess specific behaviors seen in moderate stage dementia such as wandering, distracted, perseverating, unable to use utensils, premature oral closure.

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

• Person With Dementia: Quality of Life

  The QOL scale in Alzheimer's disease (QOL--AD) is a 13--item rating of domains of physical condition, mood, memory, functional abilities, interpersonal relationships, ability to participate in meaningful activities, financial situation, and global assessments of self as a whole and QOL as a whole. Scoring instructions for QOL-AD: Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4. The total score is the sum of all 13 items (scoring ranging from 13 to 52. Higher scores indicated better quality of life.

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

• Caregiver: Quality of Life Measured With European Quality of Life (Euro-QOL)

  European Quality of Life (Euro--QL) measures 5 domains: mobility, self--care, usualactivities, pain/discomfort, and depression and have three levels of functioning each (no problems, some problems, and unable to/extreme problems). The VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

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

• Caregiver: Self Efficacy

  The self-efficacy score was a 8--item likert scale with each item rated from 1--5 (unable to most able). A total score for the instrument is provided by summing the scores of each item and dividing by the number of items producing a score in the range of 1-5. Higher overall mean scores indicate greater self efficacy.

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

Study Arms (2)

Treatment - Partners at Meals (PAM)

EXPERIMENTAL

People with dementia (PWD) often lose weight and suffer subsequent health issues: the goal of this intervention was 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 were used initially and then monthly (x5) to record mealtimes in the home, and were reviewed by the volunteer with the family member at the monthly session to discuss areas where changes could be made. Weight of the PWD was measured initially and monthly (x5).

Behavioral: Partners at Meals

Enhanced Usual Condition (EUC)

PLACEBO COMPARATOR

In the non-treatment respite care centers, an Enhanced Usual Condition was delivered to caregivers of People with Dementia (PWD). This program consisted 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) lead these groups. Weight of the PWD was measured initially and monthly (x5).

Behavioral: Enhanced Usual Condition

Interventions

Partners at Meals BEHAVIORAL

The focus of the intervention was 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. Families recorded three meals including behavior at home each month.

Also known as: PAM

Treatment - Partners at Meals (PAM)

Enhanced Usual Condition BEHAVIORAL

Enhanced Usual Condition (EUC) Staff and volunteers at the EUC sites received 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.

Also known as: EUC

Enhanced Usual Condition (EUC)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 32587748 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Weight Loss

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Respite centers (from where the participants were recruited) shut down during the pandemic. Sometimes participants wifi / internet access was limited Some caregivers expressed perceived burden of study procedures (e.g., taking pictures during mealtime and uploading) High staff / volunteer turnover in respite centers Lack of caregiver interest in participating in research

Results Point of Contact

• Title: Teresa Kelechi
• Organization: Medical University of South Carolina

kelechtj@musc.edu

843-810-3157

Study Officials

• Teresa Kelechi

  MUSC College of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants did 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 were 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).

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: August 9, 2018
• Study Start: August 15, 2017
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• Access Criteria: Contact the PIs through the College of Nursing

Locations

US (1)