Clinical trial NCT03622814: Partners at Meals - Respite Care and Home (PAM)
Official title: Mealtime Partnerships for People With Dementia in Respite Centers and at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia, Alzheimer Type
Weight Loss
Keywords: caregiving
mealtimes
respite care
train-the-trainer
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 106
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 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).
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The goal of this study was to test the efficacy of a mealtime intervention (Partners at Meals) in respite care centers (RCCs) that provided 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 used a telehealth interface to provide consultation to family caregivers in the context of home where problems arise.

The primary unit of analysis was PWD and their caregiver (CG) outcomes which included: a) PWD weight; b) dysfunctional behaviors at meals; c) quality of life (QOL) of both persons with dementia and their caregivers; and, d) CG self efficacy of managing meals at home.

Eligibility criteria: 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.

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

Primary outcomes:
measure: Monthly Weight in Pounds on a Scale for Person With Dementia
timeFrame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
measure: Person With Dementia: Dysfunctional Behavior at Meals Measured With the Edinburgh Feeding in Dementia Scale (EdFED)
timeFrame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
measure: Person With Dementia: Quality of Life
timeFrame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
measure: Caregiver: Quality of Life Measured With European Quality of Life (Euro-QOL)
timeFrame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
measure: Caregiver: Self Efficacy
timeFrame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: MUSC College of Nursing
name: Teresa Kelechi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.