Table 3.
Digital health randomized control trials in heart failure
| First author | Country | Age mean (SD) | N | Race ethnicity | Duration | Inclusion criteria | Primary outcome | Results | Device | Intervention | Health care team intervention |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Koehler et al. (2011) [87] | Germany | 66.9 (10.8) | 710 | Not reported | 18 months | Stable HF with LVEF ≤ 35% and admission in previous 2 yrs OR LVEF ≤ 25% | Death from any cause | 8.4 in RTM group vs 8.7 in UC (HR 0.97, P = 0.87) | 3-lead EKG, HBPM, weight scale, smartphone | Daily transmission of biometric data | Cardiologist or family doctor |
| Dendale et al. (2012) [88] | Belgium | 76 (10) | 160 | Not reported | 6 months | Decompensated HF | All-cause mortality | Reduced all-cause mortality in the IT vs usual care | Bluetooth scale and HBPM | Automatic transfer of data to website + emails with alerts above threshold to clinicians | GPs, Cardiologist and Nurse follow-up |
| Villani et al. (2014) [89] | Italy | 58 (12) | 94 | Not reported | 6 months | HF with LVEF < 35%, NYHA ≥ 2 | Number of HF-related hospital days | No difference in HF-related hospital days | Weight scale, HBPM, mobile phone | Upload of measurements and survey to software app that provides machine-based feedback + weekly nurse evaluation | Nurse |
| Vuorinen et al. (2014) [90] | Finland | 55 (13.7) | 100 |
62% Caucasian 9% African Canadian 7% Asian 12% other |
6 months | HF with LVEF < 40% | BNP, self-care, and quality of life measured by MLHFQ* | Significantly improved self-care score | Weight scale, HBPM, single-lead ECG recorder, MLHFQ* | Automatic upload of readings and questionnaire by email to cardiologist | Cardiologist |
| Dang et al. (2017) [91] | US | 53 (9.4) | 61 | 76% White Hispanics, 21% AA | 3 months | HF, smartphone ownership, survival expected > 6 months | Self-care efficacy | Improved self-care | Smartphone (provided by study team) | Daily surveys including weight + feedback to physicians | Study coordinator providing data to Heart Failure Clinic |
| Koehler et al. (2018) [92] | Germany | 70 (10) | 1571 | Not reported | 393 days | HF with LVEF ≤ 45% plus hospital admission in last 12 months | Percentage of days lost due to a cardiovascular admission or death | 4.88 versus 6.64% lost days (P = 0.046), all cause death 7.9 vs 11.3 100 person years (P = 0.028) | EKG device, HBPM, weight scales and oximeter, smartphone | Daily transmission of biometric data and surveys plus nurse or physician intervention | Physician or nurse |
| Melin et al. (2018) [93] | Sweden | 75 (8) | 72 | Not reported | 6 months | Admitted HF patients | Self-care behavior based on 9-item European HF Self-care Behavior Scale | Better self-care behaviors in the intervention (16.5 versus 23.5 P ≤ 0.5) | Weight scale and tablet computer | Patient education, transmission of surveys and weight | NA |
|
Chen et al (2019) [94] |
China | 61 (15) | 767 | Not reported | 180 days | Decompensated CHF, mobile phone ownership, life expectancy > 1 year | All-cause mortality | SMS and STS significantly reduced the composite endpoint and readmission in 180 days | Smartphone | Structured telephone support (STS) vs short message service (SMS) vs usual care | No |
*Minnesota Living with Heart Failure Questionnaire