Partners at Meals - Respite Care and Home (PAM)

Weight Loss Clinical Trial

— PAM  

Official title:

Mealtime Partnerships for People With Dementia in Respite Centers and at Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622814
• Other study ID #: Pro00064441
• Status: Completed
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is 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 with caregivers and develop a mealtime plan that builds on the strengths of the person with dementia, and develop a supportive environment for change. A tele-health component is involved in the communication between the respite center volunteers/staff and families. Recruitment is limited to people attending the particular respite centers.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.
• Administrator: worked with the organization for at least 3 months and plans to be in place for at least 9 more months.

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
• Administrator: plans to leave organization

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia, Alzheimer Type
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight maintenance	Assessed by monthly weight in kilograms	up to 6 months