Skip to main content

Table 1 SPIRIT diagram displaying schedule of enrollment, interventions, and assessment

From: 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

 ENROLLMENTALLOCATIONPOST- ALLOCATIONCLOSEOUT
TIMEPOINT-t10Month 1Month 2Month 3Month 4Month 5Month 6tx
ENROLLMENT
 Volunteer, PWD, and CG pre-eligibility screening checklistX        
 Informed consentX        
 Eligibility screenX        
 PWD Mini Mental Status Examination (MMSE)X        
 PWD Functional Assessment Staging Scale (FAST)X        
 Allocation (cluster) X       
INTERVENTIONS
 Volunteer recruitment and trainingX        
 PaM telehealth program (intervention)  XXXXXX 
 Enhanced usual care (control)  XXXXXX 
ASSESSMENTS
Person with Dementia (PWD)X        
 Demographics and characteristicsX        
 Weight and mid-arm circumference (MAC)X XXXXXX 
 Edinburgh Feeding in Dementia Scale (EdFED) + extra behavioral questionsX XXXXXX 
 Quality of Life in Alzheimer’s Disease (QOL-AD)X XXXXXX 
 Caloric intake (analyzed from pre and post photos of meals)  XXXXXX 
 Dysfunctional behaviors (analyzed from mealtime video recordings)  XXXXXX 
Caregiver (CG)
 Demographics and characteristicsX        
 Dementia and Mealtime knowledge test (pre/post)X      X 
 C3P Self-efficacy for change (pre/post)X      X 
 Center for Epidemiological Studies – Depression Scale (CES-D)X XXXXXX 
 Zarit 12-item Burden ScaleX XXXXXX 
 European Quality of Life (Euro-QL)X XXXXXX 
 Program satisfaction survey       X 
 Semi-structured interview       X 
Volunteer
 Demographics and characteristicsX        
 Dementia and Mealtime knowledge test (pre/post)X        
 Training satisfaction surveyX        
 C3P Self-efficacy for change (pre/post)X      X 
 Telehealth caregiver meeting logs  XXXXXX 
 Meal plan forms  XXXXXX 
 Program satisfaction survey       X 
 Semi-structured interview       X 
Administrator
 Demographics and characteristicsX        
 Program satisfaction survey       X 
 Semi-structured interview       X