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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

 

ENROLLMENT

ALLOCATION

POST- ALLOCATION

CLOSEOUT

TIMEPOINT

-t1

0

Month 1

Month 2

Month 3

Month 4

Month 5

Month 6

tx

ENROLLMENT

 Volunteer, PWD, and CG pre-eligibility screening checklist

X

        

 Informed consent

X

        

 Eligibility screen

X

        

 PWD Mini Mental Status Examination (MMSE)

X

        

 PWD Functional Assessment Staging Scale (FAST)

X

        

 Allocation (cluster)

 

X

       

INTERVENTIONS

 Volunteer recruitment and training

X

        

 PaM telehealth program (intervention)

  

X

X

X

X

X

X

 

 Enhanced usual care (control)

  

X

X

X

X

X

X

 

ASSESSMENTS

Person with Dementia (PWD)

X

        

 Demographics and characteristics

X

        

 Weight and mid-arm circumference (MAC)

X

 

X

X

X

X

X

X

 

 Edinburgh Feeding in Dementia Scale (EdFED) + extra behavioral questions

X

 

X

X

X

X

X

X

 

 Quality of Life in Alzheimer’s Disease (QOL-AD)

X

 

X

X

X

X

X

X

 

 Caloric intake (analyzed from pre and post photos of meals)

  

X

X

X

X

X

X

 

 Dysfunctional behaviors (analyzed from mealtime video recordings)

  

X

X

X

X

X

X

 

Caregiver (CG)

 Demographics and characteristics

X

        

 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

 

X

X

X

X

X

X

 

 Zarit 12-item Burden Scale

X

 

X

X

X

X

X

X

 

 European Quality of Life (Euro-QL)

X

 

X

X

X

X

X

X

 

 Program satisfaction survey

       

X

 

 Semi-structured interview

       

X

 

Volunteer

 Demographics and characteristics

X

        

 Dementia and Mealtime knowledge test (pre/post)

X

        

 Training satisfaction survey

X

        

 C3P Self-efficacy for change (pre/post)

X

      

X

 

 Telehealth caregiver meeting logs

  

X

X

X

X

X

X

 

 Meal plan forms

  

X

X

X

X

X

X

 

 Program satisfaction survey

       

X

 

 Semi-structured interview

       

X

 

Administrator

 Demographics and characteristics

X

        

 Program satisfaction survey

       

X

 

 Semi-structured interview

       

X