Study Summary
This trial is testing a new intervention to help people with dementia and their caregivers during mealtimes. The intervention will be delivered by trained volunteers in respite centers, with the goal of improving nutrition and behavior during mealtimes.
Eligible Conditions
- Alzheimer's Dementia
- Weight Loss
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: up to 6 months
up to 6 months
Weight maintenance
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Treatment - Partners at Meals (PAM)
1 of 2
Enhanced Usual Condition (EUC)
1 of 2
Experimental Treatment
Non-Treatment Group
180 Total Participants · 2 Treatment Groups
Primary Treatment: Partners at Meals · Has Placebo Group · N/A
Treatment - Partners at Meals (PAM)
Behavioral
Experimental Group · 1 Intervention: Partners at Meals · Intervention Types: BehavioralEnhanced Usual Condition (EUC)
Behavioral
PlaceboComparator Group · 1 Intervention: Enhanced Usual Condition · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
838 Previous Clinical Trials
5,378,388 Total Patients Enrolled
Teresa KelechiPrincipal InvestigatorMUSC College of Nursing
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The study included persons with dementia (PWD) who were aged ≥ 60 years and who were attending a participating respite care center (RCC) at least once/week
The administrator has worked with the organization for at least 3 months and plans to be in place for at least 9 more months.
, dressing, personal hygiene and transfers)
A caregiver is someone who lives with or on the same property as a person with a disability and provides care for that person for four or more hours per day
The volunteer is someone who is currently attending the RCC at least once a week (for at least 4 hours a week) and feels comfortable in the role of teacher or coach, and can also use televideo and photography.
References
- Amella Krug, Elaine J., Suparna Qanungo, Kelley L. Martin, Martina Mueller, Mohan Madisetti, and Teresa J. Kelechi. 2020. “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 Nutrition. Springer Science and Business Media LLC. doi:10.1186/s40795-020-00350-x.
- 2017. "Partners at Meals - Respite Care and Home (PAM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03622814.
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