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Table 1 Schedule of enrolment, intervention and assessments of the OPTIM study

From: A multi-center, randomized, controlled trial to assess the efficacy of optimization of drug prescribing in an elderly population, at 18 months of follow-up, in the evolution of functional autonomy: the OPTIM study protocol

 

Study Period

 

Enrolment

Allocation

Follow-up

Timepoint

- t1

0

t 1 : 1 month

t 2 : 6 months

t 3 : 18 months - Close-out

Enrolment:

 Eligibility screen

X

    

 Information to patients/careviger

X

    

 Collection of non-opposition to participate

X

    

 Randomized allocation

 

X

   

Intervention:

(1) Intervention: Optimization of drug prescribing

 

X

X

X

 

(2) Control

     

Assessments:

Collected in patient record:

  * Sociodemographic data

  * Diagnosis and stage

  * Current comorbidities, history of comorbidities, lifestyle habits

  * Biological exam and artrial pressure when available

 

X

   

Primary outcomes:

  * IADL scale

  * DAD-6 scale

 

X

X

X

X

Secondary outcomes:

  * MMSE (cognitive function)

  * mini-GDS (depression)

  * Hamilton scale (anxiety)

  * Pain scale

  * EUROQOL-5D (quality of life)

  * Girerd scale (compliance to drug prescribing)

  * Event and date of event: hospitalization, falls, recourse of emergency, institutionalization, death

 

X

 

X

X

 Drugs prescribing

 

X

X

X

X