Table 1.
Participant Characteristics, Study Design, Quality, and Results of Included Studies
| Study | Country | Participants (mean age, y, % female, % completed) | Intervention | Control | Intervention | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Participants (mean age, y, % female, % completed) | Participants (mean age, y, % female, % completed) | Program duration | Type of intervention | Device | Follow up duration (post) | Follow up periods (mid, post) | Analysis (PP, ITT, or both) | Comparison condition | Result | |||
| Pekmezaris et al, 2019 13 | United States: New York |
104 Black and Hispanic participants (59.9±15.1 y, 41% female, 81.7% completed) |
46 (58.4±15.2 y, 43% female, 76.1% completed) |
58 (61.1±15.0 y, 40% female, 86.2% completed) |
90 d |
TSM: (1) Daily vital self‐monitoring using (American TeleCare LifeView device) (2) Weekly telehealth visits |
American TeleCare LifeView, Telephone |
0 | 0, 90 d | ITT | Outpatient setting, based upon 2013 Heart Failure Clinical Practice Guidelines |
(1) Emergency department visits (RR, 1.37 [95% CI, 0.83–2.27]) (2) Hospitalization: (RR, 0.92 [95% CI, 0.57–1.48]) Length of stay: (TSM=0.54 d vs COM=0.91d) (3) Number of all‐cause hospitalizations: (TSM=0.78 vs COM=0.55; P=0.03) (4) Depression (Patient Health Questionnaire‐4): no significant change (5) Anxiety (Patient Health Questionnaire‐4): (TSM=50–28%; COM=57–13%; P=0.05) (6) Minnesota Living with Heart Failure Questionnaire: no significant change |
| Young et al, 2016 14 | United States: Nebraska | 100 (70.2±12.2 y, 64% female, 95.2% completed) |
51 (68.7±11.8 y, 52.9% female, 94.4% completed) |
49 (71.8±12.6 y, 75.5% female, 96.1% completed) | 12 wk |
PATCH intervention. Two phases: (1) One‐on‐one in‐hospital self‐management training session delivered by telephone (2) Post‐discharge reinforcement sessions (a) Twice a wk for the first 2 wk (b) Once a wk for wk 3–6 (c) Every other wk for wk 7–12 |
Telephone | 3 mo | 0, 3, 6 mo | PP | Usual care: standard discharge teaching for HF (written and verbal information about HF self‐care and scheduled follow‐up doctor appointments) |
(1) Significant improvement in patient reported self‐management adherence at 3 and 6 mo after discharge in intervention vs control: ‐Weighing (mean difference: 1.1, P<0.005) ‐Following a low‐sodium diet (mean difference: 0.9, P<0.005) ‐Taking prescribed medication (mean difference: 0.6, P<0.005) ‐Exercising daily (mean difference: 0.6, P<0.005) (2) No significant difference in physical activity (mean difference: 0.03 to 0.05, P>0.05) ,or clinical biomarkers (3) Significantly greater 30‐d readmission rates in intervention vs control (19.6% vs 6.1%) (4) Significant improvement in self‐efficacy for heart failure self‐management (mean difference: 0.4, P=0.03), self‐management strategies (mean difference: 1.0, P<0.005) and patient activation score (mean difference: 0.3, P=0.06) |
| Caldwell et al, 2005 16 | United States: Northern California | 36 (71±14.7 y, 31% female) | 20 (69±15.9 y, 25% female) | 16 (73±13 y, 37% female) | 1 mo | Usual care+ a simple individualized education and counseling session focused on symptom recognition and fluid weight management, with a phone call at 1 mo for reinforcement | Telephone | 2 mo | 0, 3 mo | PP | Usual care and written material |
(1) Significant improvement in knowledge after 3 mo (18.1 vs 14.9, P=0.01) (2) Significant improvement in self‐care behavior related to daily weights at 3 mo (2.9±1.0 vs 1.9±1.3, P=0.03) (3) No significant change in B‐type natriuretic peptide levels (195±170 vs 302±311 pg/mL, P=0.21) |
| Dracup et al, 2014 15 , REMOTE HF | United States: California, Kentucky, Nevada | 602 (66.1±12.9 y, 40.5% female, 82.24% completed) |
Fluid Watchers LITE: 200 (65.9±12.8 y, 42% female, 78.8% completed) Fluid Watchers LITE‐PLUS: 193 (66.1±12.9, y, 42.5% female, 82.8% completed) |
209 (66.4±12.9 y, 37.3% female, 84.5% completed) |
Fluid Watchers LITE: 4 wk Fluid Watchers LITE‐PLUS: Until content competency was demonstrated: 5.3±3.6 wk (1–19) phone calls |
Fluid Watchers LITE: 2 phone calls at 2‐wk intervals to reinforce the information in the educational session Fluid Watchers LITE‐PLUS: (1) An audiotape of the education session for future review. (2) Biweekly follow‐up phone calls by the research nurse until content competency was demonstrated |
Telephone | 24 mo | 0, 3, 12, 24 mo | ITT | Usual care |
(1) Significant improvement in self‐care scores in both LITE and PLUS groups vs control at 3 and 12 mo (2) No significant difference in the prevalence of combined clinical outcomes (cardiac death and HF hospitalization) (control: 37.8% vs LITE: 28.5% vs PLUS: 38.9%, P=0.058) over 2 y (3) No significant difference in time to HF hospitalization or cardiac death P=0.1 (4) Lower proportion of cardiac death in LITE group compared with control (control: 17.7% vs LITE: 7.5% vs PLUS: 11.9%, P=0.003) (5) Fewer scheduled or nonscheduled office visits for HF in LITE group compared with PLUS and control (control: 12.9% vs LITE: 11.5% vs PLUS: 23.8%, P=0.001) (6) No significant difference in family presence during the visits between interventions (LITE: 35% vs PLUS: 37%, P=0.6). |
| Lefler et al, 2018 17 | United States: Arkansas |
28 (82% <60 y, 43% female, 89.28% completed) |
(1) mHealth connected to a 24‐hour call center: 7 (88.7% completed) (2) Digital home equipment: 11 (81.81% completed) |
Standard care: 10 (100% completed) | 12 wk |
(1) mHealth connected to a 24‐h call center (2) Digital home equipment |
A Cloud DX‐connected Health Kit containing Android Health Tablet with Bluetooth‐paired body weight scale and pulse wave Universal serial bus blood pressure wrist monitor | 0 | 0,12 wk | PP | Standard care: regular instruction with no home equipment |
(1) 100% of mHealth and home equipment groups monitored vitals daily post intervention. (2) 36% had technology anxiety and 32% were afraid of technology. (3) Qualitative interview revealed 4 important themes regarding communication with providers, usefulness of home monitoring, confidence in self‐monitoring, and uncertainty with persistent health problems. |
COM indicates comprehensive outpatient management; HF, heart failure; ITT, intention to treat; mHealth, mobile health; PP, per‐protocol; RR, relative risk; and TSM, telehealth self‐monitoring.