Table 8 Heart Failure Studies

Scherr, 2006

Austria

Patients with chronic Heart Failure CHF or hypertension (HTN)

n = 20 (95% M)

CHF: n = 14 (93% M)

HTN: n = 6 (83% M)

Metropolitan and rural patients

Theoretical model: None

Comparison group: None

mHealth

Patient terminal: Mobile phone with Wireless Application Protocol (WAP) technology

Physician’s terminal: Personal Computer with internet access

Non-mHealth

Automatic BP monitor

Digital weight scales

Doctor–patient relationship

Patient completed questionnaires on the technical aspects of the telemonitoring system

Observational study to evaluate acceptability, feasibility and reliability of a telemonitoring system.

90 day follow-up

Long-term engagement: no engagement or follow-up reported beyond the 90 day intervention period.

Patients measured BP, HR and weight daily and transferred data via mobile phone.

Physician automatically notified by SMS of any parameters outside a pre-set range.

Study physician accessed data and phoned patient as necessary for therapeutic adjustments

Automatic reminders set by study physician

Statistical analysis: Descriptive statistics reported.

Mean Age: All, 50 (SD14) years; CHF, 53 (SD13) years; HTN, 42 (SD 16) years.

Study completion/attrition:

95% (n = 19) completed

CHF: 93% (n = 13) completed

HTN: 100% (n = 6 completed)

5% (n = 1) withdrew from TMG due to poor vision

Reliability

98% data transmission success

98% website availability for physicians.

Feasibility and Acceptability: Implausible data entry: 5 per CHF patient; 4 per patients with HTN

Successful transmissions: 83% CHF and 84% HTN

Self-measurement and data entry: CHF - 85 data transfer sessions over 90 days;

HTN - two BP and HR measures on an average of 453 out of 540 cumulative days

Patient acceptance

High, 17 patients continued with telemonitoring at study end.

Study completion/attrition: 19 participants completed. One participant withdrew due to inability to operate the mobile phone because of poor vision.

Clinical utility

CHF patients: stable or improved: mean LVEF improved from 32% to 35%; Beta-blocker initiation supported: commenced and up titrated successfully in 10 of the 14 CHF patients

Patients with HTN: BP stable; 134/80 mmHg at baseline vs 135/78 mmHg at completion

Scherr, 2009

Austria

Patients with heart failure and a hospital admission of > 24 h in the last 4 weeks.

n = 120 (66 TMG; 54 SCG)

TMG: n = 12 never beginners (50% M)

TMG: n = 54 (74% M)

CG: n = 54 (72% M)

Metropolitan centres

Rural patients not reported.

Theoretical model: None

mHealth

Mobile phone with Wireless Application Protocol (WAP) technology, Weight scale and automated BP monitor

Secure web-based CRF at monitoring centre.

Patients measured BP, HR and weight daily.

Data entered and automatically sent to the remote server at remote

Email alerts to study physician

Study physician accessed data and could phone patient on mobile

Study physician could set automatic reminders.

Non-mHealth

CG: Pharmacological care

Prospective, open-label RCT

TMG: Pharmacological treatment with telemedical surveillance

CG: pharmacological treatment alone and no planned interaction with study site.

6 months follow-up

Long-term engagement: no engagement or follow-up reported beyond the 6 month intervention period.

Statistical analysis: Per protocol principle and intention to treat analysis. Log-rank test, Kaplan-Meier estimation and relative risk reduction utilized for primary endpoint. Secondary endpoints: t-test, chi-square test, Wilcoxon rank sum test and Wilcoxon signed rank test utilized.

Median age:

12 never beginners 68 years (IQR 64–74);

TMG 65 years (IQR 62–72); CG 67 years (IQR 61–72)

Study completion/attrition: 104 participants completed. 12 participants were unable to transmit data - classified as never beginners.

4 TMG participants withdrew early (included in intention-to-treat and per-protocol analysis).

Participant adherence: 95%

Intention-to-treat analysis: TMG vs CG: 0 deaths and 11 hospitalizations (17%) vs 1 death and 17 hospitalizations (33%), a RRR of 50% (95% CI 3–74%), p = 0.06

TMG: majority of re-hospitalizations occurred in first month of follow-up.

Per protocol analysis:

TMG: 0 deaths and 8 hospitalizations (15%), a RRR of 54% (95%CI 7–79%), p = 0.04

NYHA class improved (III to II) in TMG, P < 0.001 vs CG and TMG baseline

Median length of stay: TMG 6.5 vs SCG 10.0 days (IQR 7.0–13), p = 0.04

LVEF: ns improvement in both TMG and CG. TMG 25% (IQR 20–38) to 35% (IQR 25–45) and CG 29% (IQR 21–36) to 35% (IQR 24–40)

375 alerts, 170 contacts, 55 adjustments to heart failure medications.

Seto, 2012

Canada

Heart Failure patients with LVEF < 40%

n = 100

TMG: n = 50 (82% M)

SCG: n = 50 (76% M)

Metropolitan centre (possible patients from rural or remote settings)

Theoretical model: Self-care

mHealth

TMG: Smartphone with blue tooth capability, BP monitor and scales; ECG recorder provided to 17 TMG participants – data automatically sent wirelessly to data repository.

Daily morning symptom questions

Email and text messages

Website viewing of results by clinicians and patients.

Non-mHealth

All

Pre and post study: Demographic, clinical data, SCHFI and MLHFQ questionnaires

SCG:

Clinic visits

Optimization of medication

Heart Failure education

Telephone contact

TMG:

Standard care as per SCG

Non-blinded RCT

TMG vs Standard Care Group (SCG)

Stratified 4 block randomization based on NYHA classification.

6 month follow-up: post-study questionnaire; 22 semi-structured interviews with TMG participants; 5 semi-structured interviews with clinicians

Long-term engagement: no engagement or follow-up reported beyond the 6 month intervention period.

SCG participants were not contacted by the study site until study end.

Statistical analysis: Between group analysis: Student t tests and Mann-Whitney tests. Within group analysis: Paired Student t tests and Wilcoxon signed rank tests.

Mean age: TMG 55.1 years (SD 13.7); SCG 52.3 years (13.7)

Completion/attrition: 97 participants completed. 3 participants withdrew from TMG (1 was incapacitated after a fall; 2 because of technical difficulties). No participant withdrew from SCG.

Patient adherence: 84%, 66% and 32% completed at least 50%, 80% and 95% of possible daily readings.

Health service utilization: no significant differences in hospital admissions; nights in hospital; and ED visits. Number of Heart Function Clinic visits increased in TMG (p = 0.04) due to unplanned cardiologist recalls in response to telemonitoring system alerts.

Improvement post-study for TMG and SCG - BNP values (p = 0.001 and p = 0.002);

NYHA class (p = 0.000 and 0.001); LVEF (p = 0.001); and self-care (p = 0.004 and P = 0.006). QOL improved only in the TMG (p = 0.02).

Between group post-study - only self-care maintenance (SCHFI) was significant (p = 0.03). Between group change - only overall QOL (MLHFQ) (p = 0.05)

Vuorinen, 2014,

Finland

Heart Failure patients with LVEF ≤35%, NYHA class ≥2

n = 94

TMG: n = 47 (83% M)

CG: n = 47 (83% M)

Metropolitan centre (possible patients from rural or remote settings)

Theoretical model: none

mHealth

Patient: Mobile phone with preinstalled software app

Provided with weight scale, blood pressure monitor, mobile phone with app and self-care instructions.

Non-mHealth

Multidisciplinary clinic visits and nurse feedback by telephone.

Prospective RCT

TMG vs usual care (CG)

6-month follow-up

Long term engagement: no engagement or follow-up reported beyond the 6-month intervention period

TMG:

Patients evaluated BP, HR, weight, symptoms and change in overall condition, weekly and transferred data via mobile phone application

Received by secure remote patient monitoring server

Patients received automated feedback about whether reported data was within personal targets set by nurse.

Nurses accessed data and phoned patient weekly or as necessary for out-of-target parameters or failure to upload data

CG:

Patients encouraged to measure weight, blood pressure and heart rate at home

Cardiac team monitor and interpret symptoms, optimize medication and provide education

Statistical analysis: ZIP regression used for outcome variables that expressed counts, contiguous variables analysed within and between study groups

Mean age: TMG 58.3 (SD 11.6) CG 57.9 (11.9)

Completion/attrition: 1 patient from TMG lost to follow-up.

Patient adherence = proportion of weekly submitted self-measurements by TMG:

86% weight (median = 28 (IQR 23–33),

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

Feasibility and Acceptability: 96% (44/46) from TMG responded to survey, 42/44 found making/reporting measurements with mobile app “useful” or “very useful.”

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

66% feedback drew attention to essential issues of disease,

91% feedback was motivational.

Primary Outcome: Mean HF-related hospital days: 0.7 (TMG) vs 1.4 (CG) (p = 0.351)

Secondary Outcomes:

Clinical: change in NT-proBNP, LVEF %, EHFSBS score, serum creatinine, potassium and sodium not significantly different between groups. Mortality: 0 (control), 0 (TMG).

Within group changes were significant for: LVEF increased 5.0%, p = 0.003 TMG and 4.2%, p = 0.001 CG; EHFSBS (− 5.0 points, p < 0.001 TMG and − 3.8, p < 0.001); NT-proBNP decreased in the TMG (− 198 ng/l, p = 0.01)

Use of health care resources: Mean nurse time, telephone contacts and visits higher in TMG (p < 0.001);

TMG unplanned visits to Cardiac Outpatient Clinic higher (p < 0.001);

TMG patient initiated telephone contact higher (p < 0.049);

No statistical difference between groups for physician time and visits.