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Table 7 Summary of outcome results in Heart Failure studies

From: Smartphones in the secondary prevention of cardiovascular disease: a systematic review

 

Scherr, 2006

(FUU)

Scherr, 2009

(RCT)

Seto, 2012

(RCT)

Vuorinen 2014

(RCT)

n =

20

14 CHF; 6 HTN

120

66 TMG (54 + 12 never beginners)

54 CG

100

50 TMG; 50 SCG

94

(47 TMG; 47 CG)

Program completion

95% (n = 19 of 20)

CHF: 93% (n = 13 of 14)

HTN: 100%

87% (n = 104 of 120)

TMG: 76% (n = 50 of 66, includes never beginners) or 93% (n = 50 of 54)

CG: 100%

97% (n = 97 of 100)

TMG: 88% (n = 44 of 47, includes 3 deaths)

or 94% (n = 47 of 50, excludes 3 deaths)

SCG: 100%

99% (n = 1 of 94)

TMG: 98% (n = 1 of 47)

CG: 100%

Mean age (years)

50 (SD14)

CHF: 53 (13); HTN: 42 (16)

66 (IQR 64–74)

TMG: 66 years (IQR 62–73) CG: 67 years (IQR 61–72)

TMG: 55.1 ± 13.7

SCG: 52.3 ± 13.7

TMG: 58.3 ± 11.6

CG: 57.9 ± 11.9

Technology (Reported inconsistently)

Feasibility

✓high

   

Usability/Acceptability

80% did not report any problems with data entry

98% system availability

 

10–20 min initial education on use of mobile phone app.

TMG: 1 patient withdrew due to increased anxiety from monitoring his condition.

Technical

98% data transmission and website availability

One (5%) withdrawl (poor vision)

12 never beginners (median age 68 years (IQR 64–74) were unable to begin transmission of data (reasons NR)

TMG: 2 participants withdrew due to technical difficulties

TMG: 6 telephone calls re technical problems.

3 nurse initiated calls for start-up support;

3 patient calls initiated for failed internet connection.

Engagement/Adherence/ Usage/Task completion

94% (CHF) and 84% (HTN) self-measurement and data entry

95% patient adherence

Completion of daily readings:

84% completed 50%;

66% completed 80%;

32% completed 95%.

Proportion of weekly submitted self-measurements by TMG:

86% weight (median = 28 (IQ 23–33);

89% BP, HR, and symptoms (median BP and symptoms = 32 (IQR 27–43).

Patient

 

Patient satisfaction

85% of patients continued telemonitoring at study completion

  

96% responded to user experience questionnaire

95% - measures very or quite useful

91% - automatic feedback very or quite useful (9% no benefit)

66% - feedback drew attention to essential issues of disease

91% - feedback was motivational

Quality of Life

  

Ç‚ overall MLHFQ

Ç‚ Physical

Ç‚ Emotional

++ Overall change (p = 0.05)

 

Self-care

  

ǂ † Maintenance

ǂ † Management

++ Maintenance

ns

ǂ †

New York Heart Association class

Study completion vs baseline

Class I: n = 3 vs 0

Class II: n = 11 vs 10

Class III: n = 0 vs 4

++ (PPA)

ǂ †

 

Left Ventricular Ejection Fraction

↑ in mean to 35% at study completion (vs 32% at baseline)

PPA: ns improvement

TMG: 25% (IQR 20–38) to 35% (IQR 25–45)

CG: 29% (IQR 21–36) to 35% (IQR 24–40)

ǂ †

ns

ǂ †

Blood Pressure

HTN: mean study completion

SBP 135 (SD18); DPB 78 (7) vs baseline SBP 134 (21); DBP 80 (8)

   

Medication

CHF: 71% had beta-blocker therapy initiated with a titrated increase

HTN: antihypertensive medication stable

 

Ç‚ Aldosterone antagonists

++

Medication change, both increases and decreases.

Biochemistry

   

ns

Serum potassium, creatinine, sodium.

Brain Natriuretic Peptide

  

ǂ †

ns

Ç‚

Mortality/Health service utilization

 

ITT: ns

TMG: 17% (0 deaths/11) hospitalizations

CG: 31% (1 death/17 hospitalizations)

PPA: ++

TMG: 15% (0 deaths/8 hospitalizations)

PPA: ++ shorter length of hospital stay

TMG: 6% (n = 3) deaths (2 non-heart related)

SCG: 0 deaths

ns hospital admissions; nights in hospital; ED visits

++ Heart Function Clinic visits (TMG: 3.5 (SD 3.6); SCG 2.5 (2.5)

No mortality in TMG or CG

ns HF related hospital days

++ TMG nurse time, telephone contact and visits

++ TMG unplanned clinic visits

++ patient initiated telephone contact

ns physician time and visits

  1. Key: FUU Feasibility, Utility and Uptake study, RCT Randomised Control Trial, CHF Chronic Heart Failure, HTN Hypertension, TMG Telemonitoring Group, SCG Standard Care Group, CG Control Group, QOL Quality of life, SBP Systolic Blood Pressure, DBP Diastolic Blood Pressure, ECG Electrocardiogram, ED Emergency Department, NR not reported
  2. FUU studies - pre- compared with post-intervention: + = significant improvement with mHealth; # = no significant improvement with mHealth; NR = not reported; ↑ = increased; ✓ = reported as feasible
  3. RCT studies: ++ = significant improvement in TMG compared with SCG (or CG); ns = no significant difference between TMG and SCG (or CG);
  4. ≠ = significant improvement in SCG (or CG) compared with TMG; ǂ = significant TMG within-group differences at 6 months; † = significant SCG (or CG) within-group differences at 6 months; ITT = Intention to treat analysis: PPA = Per Protocol Analysis