A Randomized Controlled Trial of Mobile Health Intervention in Patients With Heart Failure and Diabetes

Felker, G. Michael; Sharma, Abhinav; Mentz, Robert J.; She, Lilin; Green, Cynthia L.; Granger, Bradi B.; Heitner, John F.; Cooper, Lauren B.; Teuteberg, J.; Grodin, Justin L.; Rosenfield, Kenneth; Hudson, Lori L.; Kwee, Lydia Coulter; Shah, Svati H.

doi:10.1016/j.cardfail.2022.07.048

Cited by 11 publications

(26 citation statements)

References 28 publications

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“…Included studies were published between 2004 and 2022. Seven studies were conducted in the United States [ 15 – 17 , 19 , 20 , 22 , 23 ]. One study was conducted in the Netherlands and another in Argentina [ 18 , 21 ].…”

Section: Resultsmentioning

confidence: 99%

The use of technology to improve medication adherence in heart failure patients: a systematic review of randomised controlled trials

Cheng

Donovan

Al-Jawad

et al. 2023

J of Pharm Policy and Pract

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Background Heart failure is an ever-growing contributor to morbidity and mortality in the ageing population. Medication adherence rates among the HF population vary widely in the literature, with a reported range of 10–98%. Technologies have been developed to improve adherence to therapies and other clinical outcomes. Aims This systematic review aims to investigate the effect of different technologies on medication adherence in patients with heart failure. It also aims to determine their impact on other clinical outcomes and examine the potential of these technologies in clinical practice. Methods This systematic review was conducted using the following databases: PubMed Central UK, Embase, MEDLINE, CINAHL Plus, PsycINFO and Cochrane Library until October 2022. Studies were included if they were randomised controlled trials that used technology to improve medication adherence as an outcome in heart failure patients. The Cochrane Collaboration's Risk of Bias tool was used to assess individual studies. This review was registered with PROSPERO (ID: CRD42022371865). Results A total of nine studies met the inclusion criteria. Two studies showed statistically significant improvement in medication adherence following their respective interventions. Eight studies had at least one statistically significant result in the other clinical outcomes it measured, including self-care, quality of life and hospitalisations. All studies that evaluated self-care management showed statistically significant improvement. Improvements in other outcomes, such as quality of life and hospitalisations, were inconsistent. Conclusion It is observable that there is limited evidence for using technology to improve medication adherence in heart failure patients. Further studies with larger study populations and validated self-reporting methods for medication adherence are required.

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Section: Resultsmentioning

confidence: 99%

The use of technology to improve medication adherence in heart failure patients: a systematic review of randomised controlled trials

Cheng

Donovan

Al-Jawad

et al. 2023

J of Pharm Policy and Pract

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“…Furthermore, 13 RCTs offered rehabilitation as part of the intervention [64,75,80,82,147,149,151,152,157,160,163,169,178]. mHealth solutions (eg, telephone calls, text messages, and apps) were primarily used in 56 RCTs [53,56,57,59,63,67,69,78-80, 83-86,90,92,93,96,99,101,102,105,108,110,112-115,119, 120,124,128-130,134,136,140-142,146-148,150,155,157,161,163, 164,167,168,172,176,177,179,181,185], whereas 22 RCTs [58,60,61,65,70,81,87,111,116,117,126,133,134,145,149,151,154,156,165,171,173,174] used mHealth combined with a device (eg, wearable, pedometer, activity tracker, or Bluetooth-connected pulse oximeter or glycosometer). Furthermore, 6 RCTs [75,89,118,158,169,183]…”

Section: Intervention Componentsmentioning

confidence: 99%

“…Type 2 diabetes [53,56,58,59,66,67,81,84,88,92,93,97,99,104,107,[114][115][116]119,122,123,[126][127][128]130,131,140,145,146,155,157,159,165,168,172,182,184] and heart disease [62,64,65,70,72,73,75,80,85,87,96,98,102,106,109,[111][112]...…”

Section: Chronic Conditionsmentioning

confidence: 99%

“…objectively measured physical activity, 6% (3/51) of the RCTs were classified as low risk of bias[58,84,160], 55% (28/51) of the RCTs had some concerns[53,61,62,68,70,71,74,81,82,95,97,98,100,102,107,111,115,117,136,143,144,147,148,155,156,166,180,182,183,[188][189][190][191], and 39% (20/51) of the RCTs were classified as high risk of bias[60,65,69,81,91,94,99,104,125,[130][131][132]145,146,149,151,152,163,164,186] (Figure…”

mentioning

confidence: 99%

“…The mean number of digital sessions was 97.98 (SD 109.29; range 2-377), whereas in-person sessions had a mean of 3.26 (SD 2.93; range 0-18). Of the included RCTs, 31[54,58,62,65,70,76,77,82,84,86,88,92,94,95,100,101,112,121,132,135,143,144,146,150,151,155,163,164,174,182,186,[189][190][191]197] had follow-up data, and the mean follow-up time was 45.38 (SD 21.74; range 12-104) weeks.…”

mentioning

confidence: 99%

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Benefits and Harms of Digital Health Interventions Promoting Physical Activity in People With Chronic Conditions: Systematic Review and Meta-Analysis

Zangger¹,

Liaghat²,

Juhl³

et al. 2023

J Med Internet Res

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Background Digital health interventions for managing chronic conditions have great potential. However, the benefits and harms are still unclear. Objective This systematic review and meta-analysis aimed to investigate the benefits and harms of digital health interventions in promoting physical activity in people with chronic conditions. Methods We searched the MEDLINE, Embase, CINAHL, and Cochrane Central Register of Controlled Trials databases from inception to October 2022. Eligible randomized controlled trials were included if they used a digital component in physical activity promotion in adults with ≥1 of the following conditions: depression or anxiety, ischemic heart disease or heart failure, chronic obstructive pulmonary disease, knee or hip osteoarthritis, hypertension, or type 2 diabetes. The primary outcomes were objectively measured physical activity and physical function (eg, walk or step tests). We used a random effects model (restricted maximum likelihood) for meta-analyses and meta-regression analyses to assess the impact of study-level covariates. The risk of bias was assessed using the Cochrane Risk of Bias 2 tool, and the certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation. Results Of 14,078 hits, 130 randomized controlled trials were included. Compared with usual care or minimal intervention, digital health interventions increased objectively measured physical activity (end of intervention: standardized mean difference [SMD] 0.29, 95% CI 0.21-0.37; follow-up: SMD 0.17, 95% CI 0.04-0.31) and physical function (end of intervention: SMD 0.36, 95% CI 0.12-0.59; follow-up: SMD 0.29, 95% CI 0.01-0.57). The secondary outcomes also favored the digital health interventions for subjectively measured physical activity and physical function, depression, anxiety, and health-related quality of life at the end of the intervention but only subjectively measured physical activity at follow-up. The risk of nonserious adverse events, but not serious adverse events, was higher in the digital health interventions at the end of the intervention, but no difference was seen at follow-up. Conclusions Digital health interventions improved physical activity and physical function across various chronic conditions. Effects on depression, anxiety, and health-related quality of life were only observed at the end of the intervention. The risk of nonserious adverse events is present during the intervention, which should be addressed. Future studies should focus on better reporting, comparing the effects of different digital health solutions, and investigating how intervention effects are sustained beyond the end of the intervention. Trial Registration PROSPERO CRD42020189028; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=189028

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Novel Trial Designs in Heart Failure: Using Digital Health Tools to Increase Pragmatism

DeVore,

Fudim,

Lund

2023

Curr Heart Fail Rep

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A Randomized Controlled Trial of Mobile Health Intervention in Patients With Heart Failure and Diabetes

Cited by 11 publications

References 28 publications

The use of technology to improve medication adherence in heart failure patients: a systematic review of randomised controlled trials

The use of technology to improve medication adherence in heart failure patients: a systematic review of randomised controlled trials

Benefits and Harms of Digital Health Interventions Promoting Physical Activity in People With Chronic Conditions: Systematic Review and Meta-Analysis

Novel Trial Designs in Heart Failure: Using Digital Health Tools to Increase Pragmatism

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