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Table 2 Study schedule of enrollment, allocation, interventions, and assessment

From: Rationale and study protocol for We-PAP: a randomized pilot/feasibility trial of a couples-based intervention to promote PAP adherence and sleep health compared to an educational control

 

Study period

Timepoint

Enrollment

Pre-intervention assessment

Allocation

Post-allocation

Intervention

Post-intervention 1-month assessment follow-up

Post-intervention 3-month assessment follow-up

Enrollment

 Eligibility screen

X

     

 Informed consent

X

X

    

 Allocation

  

X

   

Intervention

 We-PAP group

   

X

  

 Information control group

   

X

  

Data collection

 Demographics

 

X

    

 OSA severity (AHI)

 

X

 

X

 

X

Primary outcomes

 PAP adherence

 

X

 

X

 

X

Secondary outcomes

 Sleep quality (objective)

 

X

 

X

 

X

 Sleep diary

 

X

 

X

 

X

 Sleep disturbance

 

X

 

X

X

X

 Sleep-related impairment

 

X

 

X

X

X

 Relationship quality

 

X

 

X

X

X

 Cognitive function

 

X

   

X

Process/intervention-related variables

 Feasibility/acceptability

   

X

X

X

 Intervention fidelity

   

X

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