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Table 1 Measures & design

From: Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial

Construct/Measure

Methods of assessment

T0 Pre

T1 Post

T2

T3

T4

T5

Primary outcomes

       

Adherence

Objective: Monitor output

X

X

    
 

Refill rate pharmacy

MR

MR

 

MR

 

MR

 

Subjective: MAS, MOS-adhere

Q

Q

T

Q

T

Q

Healthcare Consumption

Number of rehospitalisations, time to first HF-related hospitalization, visits to the GP and ER due to cardiac causes, DBC codes

MR

MR

MR

MR

MR

MR

 

TiC-P,

Q

Q

T

Q

T

Q

Secondary outcomes

       

Physical function,

6-minute walk test

A

A

 

A

 

A

disease progression

NYHA, LVEF

S

S

 

S

 

S

Quality of life

KCCQ

Q

Q

 

Q

 

Q

Predictors

       

Sociodemographic

Self-report, postal code area

Q

     

Self-care behavior

EHFScBS-9

Q

Q

 

Q

 

Q

Cognitive function

MMSE

A

A

 

A

 

A

Depression

PHQ9, BDI10

Q

Q

 

Q

 

Q

Anxiety

GAD7, SAD4

Q

Q

 

Q

 

Q

Type D personality

DS14

Q

Q

    
  1. NB. Multiple instruments are used to assess anxiety and depression since there is no gold standard or consensus which instruments to use in patients with somatic disease. All psychological questionnaires are standardized and validated. Variables obtained from: S = standard measures in routine clinical care visits, A = additional assessment physical/cognitive functioning, MR = medical records, Q = questionnaire, X = intervention, T = telephone call.