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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    ǂ overall MLHFQ
ǂ Physical
ǂ 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
  ǂ Aldosterone antagonists ++
Medication change, both increases and decreases.
Biochemistry     ns
Serum potassium, creatinine, sodium.
Brain Natriuretic Peptide    ǂ † ns
ǂ
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
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