Efficacy of a Smartphone App Intervention for Reducing Caregiver Stress: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Matthew Fuller-Tyszkiewicz ◽  
Ben Richardson ◽  
Keriann Little ◽  
Samantha Teague ◽  
Linda Hartley-Clark ◽  
...  
Keyword(s):  
Active Control ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Self Esteem ◽  
Mobile App ◽  
Control Group ◽  
Self Monitoring

BACKGROUND Caregivers play a pivotal role in maintaining an economically viable health care system, yet they are characterized by low levels of psychological well-being and consistently report unmet needs for psychological support. Mobile app–based (mobile health [mHealth]) interventions present a novel approach to both reducing stress and improving well-being. OBJECTIVE This study aims to evaluate the effectiveness of a self-guided mobile app–based psychological intervention for people providing care to family or friends with a physical or mental disability. METHODS In a randomized, single-blind, controlled trial, 183 caregivers recruited through the web were randomly allocated to either an intervention (n=73) or active control (n=110) condition. The intervention app contained treatment modules combining daily self-monitoring with third-wave (mindfulness-based) cognitive-behavioral therapies, whereas the active control app contained only self-monitoring features. Both programs were completed over a 5-week period. It was hypothesized that intervention app exposure would be associated with decreases in depression, anxiety, and stress, and increases in well-being, self-esteem, optimism, primary and secondary control, and social support. Outcomes were assessed at baseline, postintervention, and 3-4 months postintervention. App quality was also assessed. RESULTS In total, 25% (18/73) of the intervention participants were lost to follow-up at 3 months, and 30.9% (34/110) of the participants from the wait-list control group dropped out before the postintervention survey. The intervention group experienced reductions in stress (<i>b</i>=−2.07; <i>P</i>=.04) and depressive symptoms (<i>b</i>=−1.36; <i>P</i>=.05) from baseline to postintervention. These changes were further enhanced from postintervention to follow-up, with the intervention group continuing to report lower levels of depression (<i>b</i>=−1.82; <i>P</i>=.03) and higher levels of emotional well-being (<i>b</i>=6.13; <i>P</i>&lt;.001), optimism (<i>b</i>=0.78; <i>P</i>=.007), self-esteem (<i>b</i>=−0.84; <i>P</i>=.005), support from family (<i>b</i>=2.15; <i>P</i>=.001), support from significant others (<i>b</i>=2.66; <i>P</i>&lt;.001), and subjective well-being (<i>b</i>=4.82; <i>P</i>&lt;.001). On average, participants completed 2.5 (SD 1.05) out of 5 treatment modules. The overall quality of the app was also rated highly, with a mean score of 3.94 out of a maximum score of 5 (SD 0.58). CONCLUSIONS This study demonstrates that mHealth psychological interventions are an effective treatment option for caregivers experiencing high levels of stress. Recommendations for improving mHealth interventions for caregivers include offering flexibility and customization in the treatment design. CLINICALTRIAL Australian New Zealand Clinical Trial Registry ACTRN12616000996460; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371170

scholarly journals Efficacy of a Smartphone App Intervention for Reducing Caregiver Stress: Randomized Controlled Trial

10.2196/17541 ◽  
2020 ◽  
Vol 7 (7) ◽  
pp. e17541
Author(s):  
Matthew Fuller-Tyszkiewicz ◽  
Ben Richardson ◽  
Keriann Little ◽  
Samantha Teague ◽  
Linda Hartley-Clark ◽  
...  
Keyword(s):  
Active Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Self Esteem ◽  
Mobile App ◽  
Trial Registration ◽  
Control Group ◽  
Self Monitoring

Background Caregivers play a pivotal role in maintaining an economically viable health care system, yet they are characterized by low levels of psychological well-being and consistently report unmet needs for psychological support. Mobile app–based (mobile health [mHealth]) interventions present a novel approach to both reducing stress and improving well-being. Objective This study aims to evaluate the effectiveness of a self-guided mobile app–based psychological intervention for people providing care to family or friends with a physical or mental disability. Methods In a randomized, single-blind, controlled trial, 183 caregivers recruited through the web were randomly allocated to either an intervention (n=73) or active control (n=110) condition. The intervention app contained treatment modules combining daily self-monitoring with third-wave (mindfulness-based) cognitive-behavioral therapies, whereas the active control app contained only self-monitoring features. Both programs were completed over a 5-week period. It was hypothesized that intervention app exposure would be associated with decreases in depression, anxiety, and stress, and increases in well-being, self-esteem, optimism, primary and secondary control, and social support. Outcomes were assessed at baseline, postintervention, and 3-4 months postintervention. App quality was also assessed. Results In total, 25% (18/73) of the intervention participants were lost to follow-up at 3 months, and 30.9% (34/110) of the participants from the wait-list control group dropped out before the postintervention survey. The intervention group experienced reductions in stress (b=−2.07; P=.04) and depressive symptoms (b=−1.36; P=.05) from baseline to postintervention. These changes were further enhanced from postintervention to follow-up, with the intervention group continuing to report lower levels of depression (b=−1.82; P=.03) and higher levels of emotional well-being (b=6.13; P<.001), optimism (b=0.78; P=.007), self-esteem (b=−0.84; P=.005), support from family (b=2.15; P=.001), support from significant others (b=2.66; P<.001), and subjective well-being (b=4.82; P<.001). On average, participants completed 2.5 (SD 1.05) out of 5 treatment modules. The overall quality of the app was also rated highly, with a mean score of 3.94 out of a maximum score of 5 (SD 0.58). Conclusions This study demonstrates that mHealth psychological interventions are an effective treatment option for caregivers experiencing high levels of stress. Recommendations for improving mHealth interventions for caregivers include offering flexibility and customization in the treatment design. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12616000996460; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371170

scholarly journals Resilience@Work Mindfulness Program: Results From a Cluster Randomized Controlled Trial With First Responders (Preprint)

2018 ◽  
Author(s):  
Sadhbh Joyce ◽  
Fiona Shand ◽  
Tara J Lal ◽  
Brendan Mott ◽  
Richard A Bryant ◽  
...  
Keyword(s):  
High Risk ◽  
Controlled Trial ◽  
Intervention Group ◽  
First Responders ◽  
Well Being ◽  
Control Group ◽  
Resilience Training ◽  
Cluster Randomized ◽  
Adaptive Resilience

BACKGROUND A growing body of research suggests that resilience training can play a pivotal role in creating mentally healthy workplaces, particularly with regard to protecting the long-term well-being of workers. Emerging research describes positive outcomes from various types of resilience training programs (RTPs) among different occupational groups. One specific group of workers that may benefit from this form of proactive resilience training is first responders. Given the nature of their work, first responders are frequently exposed to stressful circumstances and potentially traumatic events, which may impact their overall resilience and well-being over time. OBJECTIVE This study aimed to examine whether a mindfulness-based RTP (the Resilience@Work [RAW] Mindfulness Program) delivered via the internet can effectively enhance resilience among a group of high-risk workers. METHODS We conducted a cluster randomized controlled trial (RCT) comprising 24 Primary Fire and Rescue and Hazmat stations within New South Wales. Overall, 12 stations were assigned to the 6-session RAW Mindfulness Program and 12 stations were assigned to the control condition. A total of 143 active full-time firefighters enrolled in the study. Questionnaires were administered at baseline, immediately post training, and at 6-month follow-up. Measurements examined change in both adaptive and bounce-back resilience as well as several secondary outcomes examining resilience resources and acceptance and mindfulness skills. RESULTS Mixed-model repeated measures analysis found that the overall test of group-by-time interaction was significant (P=.008), with the intervention group increasing in adaptive resilience over time. However, no significant differences were found between the intervention group and the control group in terms of change in bounce-back resilience (P=.09). At 6-month follow-up, the group receiving the RAW intervention had an average increase in their resilience score of 1.3, equating to a moderate-to-large effect size compared with the control group of 0.73 (95% CI 0.38-1.06). Per-protocol analysis found that compared with the control group, the greatest improvements in adaptive resilience were observed among those who completed most of the RAW program, that is, 5 to 6 sessions (P=.002). CONCLUSIONS The results of this RCT suggest that mindfulness-based resilience training delivered in an internet format can create improvements in adaptive resilience and related resources among high-risk workers, such as first responders. Despite a number of limitations, the results of this study suggest that the RAW Mindfulness Program is an effective, scalable, and practical means of delivering online resilience training in high-risk workplace settings. To the best of our knowledge, this is the first time a mindfulness-based RTP delivered entirely via the internet has been tested in the workplace. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12615000574549; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368296 (Archived by WebCite at http://www.webcitation.org/75w4xtrpw).

scholarly journals Prevention of Depressive Symptoms and Promotion of Well-being in Adolescents: A Randomized Controlled Trial of the Smile Program

2019 ◽  
Vol 35 (2) ◽  
pp. 300-313
Author(s):  
Óscar Sánchez-Hernández ◽  
Francisco X. Méndez ◽  
Manuel Ato ◽  
Judy Garber
Keyword(s):  
Depressive Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Behavioral Approach ◽  
Control Group ◽  
Post Intervention ◽  
Post Test ◽  
Intervention Condition

This study addressed the development and evaluation of the Smile Program whose main objective was the prevention of depression and the promotion of well-being in adolescents. The program is based on interventions that have been shown to be efficacious (a cognitive-behavioral approach). Participants were 89 adolescents (mean age = 13.88 years; SD = 0.95) recruited from a sample of 1212 students from seven schools. Results showed a significant reduction in self-reported depressive symptoms in the intervention group (n= 51) as compared to youth in the control group (n= 38). Based on parents’ report (n=56), youth in the intervention group had significantly better self-esteem at post-test as compared to youth in the control group. At four months post intervention, youth in the intervention group had higher psychological well-being than those in the control group; at the 8-month follow-up, youth in the intervention condition reported better family self-concept.

scholarly journals A New Mental Health Mobile App for Well-Being and Stress Reduction in Working Women: Randomized Controlled Trial

10.2196/14269 ◽  
2019 ◽  
Vol 21 (11) ◽  
pp. e14269 ◽  
Author(s):  
Cássia Canha Coelhoso ◽  
Patricia Renovato Tobo ◽  
Shirley Silva Lacerda ◽  
Alex Heitor Lima ◽  
Carla Regina Camara Barrichello ◽  
...  
Keyword(s):  
Mental Health ◽  
Repeated Measures ◽  
Intervention Group ◽  
Working Women ◽  
Well Being ◽  
Mobile App ◽  
World Health ◽  
Control Group ◽  
Work Related

Background Although the availability and use of mobile mental health apps has grown exponentially in recent years, little data are available regarding their efficacy. Objective This study aimed to evaluate the effectiveness of an app developed to promote stress management and well-being among working women compared with a control app. Methods Female employees at a private hospital were invited to participate in the study via mailing lists and intranet ads. A total of 653 individuals self-enrolled through the website. Eligible participants were randomized between control (n=240) and intervention (n=250) groups. The well-being mobile app provides an 8-week program with 4 classes per week (including a brief theoretical portion and a 15-min guided practice). The active control app also provided 4 assessments per week that encouraged participants to self-observe how they were feeling for 20 min. We also used the app to conduct Web-based questionnaires (10-item Perceived Stress Scale and 5-item World Health Organization Well-Being Index) and ask specific questions to assess subjective levels of stress and well-being at baseline (t1), midintervention (t4=4 weeks after t1) and postintervention (t8=8 weeks after t1). Both apps were fully automated without any human involvement. Outcomes from the control and intervention conditions at the 3 time points were analyzed using a repeated measures analysis of variance. Results Among the randomized participants (n=490), 185 participants were excluded at the 4-week follow-up and another 79 at the 8-week follow-up because of noncompliance with the experimental protocol. Participants who did not complete t4 and t8 assessments were equally distributed between groups (t4: control group=34.6% [83/240] and intervention group=40.8% [102/250]; P=.16; t8: control group=29.9% [47/157] and intervention group=21.6% [32/148]; P=.10). Both groups showed a significant increase in general well-being as a function of time (F2,426=5.27; P=.006), but only the intervention group presented a significant increase in work-related well-being (F2,426=8.92; P<.001), as well as a significant reduction in work-related and overall stress (F2,426=5.50; P=.004 and F2,426=8.59; P<.001, respectively). Conclusions The well-being mobile app was effective in reducing employee stress and improving well-being. Trial Registration Clinicaltrials.gov NCT02637414; https://clinicaltrials.gov/ct2/show/NCT02637414.

scholarly journals Efficacy of the Digital Therapeutic Mobile App BioBase to Reduce Stress and Improve Mental Well-Being Among University Students: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Sonia Ponzo ◽  
Davide Morelli ◽  
Jamie M Kawadler ◽  
Nicola Rose Hemmings ◽  
Geoffrey Bird ◽  
...  
Keyword(s):  
University Students ◽  
Controlled Trial ◽  
Well Being ◽  
Mobile App ◽  
Control Group ◽  
Full Time ◽  
Digital Version ◽  
Sustained Effects ◽  
Mental Well Being

BACKGROUND University students in the United Kingdom are experiencing increasing levels of anxiety. A program designed to increase awareness of one’s present levels of well-being and suggest personalized health behaviors may reduce anxiety and improve mental well-being in students. The efficacy of a digital version of such a program, providing biofeedback and therapeutic content based on personalized well-being metrics, is reported here. OBJECTIVE The aim of this study was to test the efficacy and sustained effects of using a mobile app (BioBase) and paired wearable device (BioBeam), compared with a waitlist control group, on anxiety and well-being in university students with elevated levels of anxiety and stress. METHODS The study employed a randomized, waitlist-controlled trial with assessments at baseline, 2 weeks, postintervention (4 weeks), and follow-up (6 weeks). Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored &gt;14 points on the Depression, Anxiety, and Stress Scale-21 items (DASS-21) stress subscale or &gt;7 points on the DASS-21 anxiety subscale, (3) owned an iOS mobile phone, (4) did not have any previous psychiatric or neurological conditions, (6) were not pregnant at the time of testing, and (7) were able to read and understand English. Participants were encouraged to use BioBase daily and complete at least one course of therapeutic content. A <i>P</i> value ≤.05 was considered statistically significant. RESULTS We found that a 4-week intervention with the BioBase program significantly reduced anxiety and increased perceived well-being, with sustained effects at a 2-week follow-up. Furthermore, a significant reduction in depression levels was found following the 4-week usage of BioBase. CONCLUSIONS This study shows the efficacy of a biofeedback digital intervention in reducing self-reported anxiety and increasing perceived well-being in UK university students. Results suggest that digital mental health interventions could constitute a novel approach to treat stress and anxiety in students, which could be combined or integrated with existing therapeutic pathways. CLINICALTRIAL Open Science Framework (OSF.io) 2zd45; https://osf.io/2zd45/

scholarly journals Is there an app for that? A cluster randomised controlled trial of a mobile app–based mental health intervention

2019 ◽  
Vol 26 (3) ◽  
pp. 1538-1559 ◽  
Author(s):  
Rachel Kenny ◽  
Amanda Fitzgerald ◽  
Ricardo Segurado ◽  
Barbara Dooley
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Well Being ◽  
Mobile App ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled

Demand for the use of mobile apps in mental health interventions has grown in recent years, particularly among adolescents who experience elevated levels of distress. However, there is a scarcity of evidence for the effectiveness of these tools within this population. The aim of this study was to test the effectiveness of CopeSmart, a mental health mobile app, using a multicentre cluster randomised controlled trial design. Participants were 15–18-years-olds (N = 560) recruited from 10 schools randomly assigned to an intervention or control condition. Intervention participants used the app over a 4-week period. Multi-level modelling analyses revealed no significant changes in the intervention group from pre-test to post-test, when compared to the control group, in terms of emotional distress, well-being, emotional self-awareness or coping strategies. Findings suggest that a 4-week app-based intervention may not be enough to elicit intra-personal changes in mental health outcomes in a general adolescent population.

scholarly journals Brief self-affirmation intervention for adults with psoriasis for reducing anxiety and depression and boosting well-being: Evidence from a randomized controlled trial

2021 ◽  
pp. 1-11
Author(s):  
Patryk Łakuta
Keyword(s):  
Mental Health ◽  
Health Outcomes ◽  
Active Control ◽  
Implementation Intentions ◽  
Controlled Trial ◽  
Well Being ◽  
Mental Health Outcomes ◽  
Control Group ◽  
Post Intervention

Abstract Background There are relatively few studies to address mental health implications of self-affirming, especially across groups experiencing a chronic health condition. In this study, short- and longer-term effects of a brief self-affirmation intervention framed in terms of implementation intentions (if-then plans with self-affirming cognitions; S-AII) were evaluated against an active control group (non-affirming implementation intentions; N-AII), matched to the target condition, and mere goal intention condition (a non-active control) in adults with psoriasis. The three pre-registered primary outcomes captured depression, anxiety, and well-being. Methods Adults with psoriasis (N = 175; Mage = 36.53, s.d. = 11.52) were randomized into S-AII, N-AII, or control. Participants' mental health outcomes were assessed prior to randomization (at baseline), at week 2 (post-intervention), and at a 1-month follow-up. Results Linear mixed models were used and results were reported on the intention-to-treat principle. Analyses revealed that S-AII exerted significantly more improvement in the course of well-being (ds > 0.25), depressive symptoms (ds > −0.40), and anxiety (ds > −0.45) than the N-AII and control group at 2-week post-intervention. Though the differences between groups faded at 1-month follow-up, the within-group changes over time for S-AII in all mental health outcomes remained significant. Conclusions Brief and low-intensity S-AII intervention exerted in the short-term a considerable impact on mental health outcomes. The S-AII shows promising results as a relevant public mental health strategy for enhancing well-being and reducing psychological distress. Future studies could consider whether these effects can be further enhanced with booster interventions.

scholarly journals A New Mental Health Mobile App for Well-Being and Stress Reduction in Working Women: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Cássia Canha Coelhoso ◽  
Patricia Renovato Tobo ◽  
Shirley Silva Lacerda ◽  
Alex Heitor Lima ◽  
Carla Regina Camara Barrichello ◽  
...  
Keyword(s):  
Mental Health ◽  
Repeated Measures ◽  
Intervention Group ◽  
Working Women ◽  
Well Being ◽  
Mobile App ◽  
World Health ◽  
Control Group ◽  
Work Related

BACKGROUND Although the availability and use of mobile mental health apps has grown exponentially in recent years, little data are available regarding their efficacy. OBJECTIVE This study aimed to evaluate the effectiveness of an app developed to promote stress management and well-being among working women compared with a control app. METHODS Female employees at a private hospital were invited to participate in the study via mailing lists and intranet ads. A total of 653 individuals self-enrolled through the website. Eligible participants were randomized between control (n=240) and intervention (n=250) groups. The well-being mobile app provides an 8-week program with 4 classes per week (including a brief theoretical portion and a 15-min guided practice). The active control app also provided 4 assessments per week that encouraged participants to self-observe how they were feeling for 20 min. We also used the app to conduct Web-based questionnaires (10-item Perceived Stress Scale and 5-item World Health Organization Well-Being Index) and ask specific questions to assess subjective levels of stress and well-being at baseline (<italic>t</italic><sub>1</sub>), midintervention (<italic>t</italic><sub>4</sub>=4 weeks after <italic>t</italic><sub>1</sub>) and postintervention (<italic>t</italic><sub>8</sub>=8 weeks after <italic>t</italic><sub>1</sub>). Both apps were fully automated without any human involvement. Outcomes from the control and intervention conditions at the 3 time points were analyzed using a repeated measures analysis of variance. RESULTS Among the randomized participants (n=490), 185 participants were excluded at the 4-week follow-up and another 79 at the 8-week follow-up because of noncompliance with the experimental protocol. Participants who did not complete <italic>t</italic><sub>4</sub> and <italic>t</italic><sub>8</sub> assessments were equally distributed between groups (<italic>t</italic><sub>4</sub>: control group=34.6% [83/240] and intervention group=40.8% [102/250]; <italic>P</italic>=.16; <italic>t</italic><sub>8</sub>: control group=29.9% [47/157] and intervention group=21.6% [32/148]; <italic>P</italic>=.10). Both groups showed a significant increase in general well-being as a function of time (<italic>F</italic><sub>2,426</sub>=5.27; <italic>P</italic>=.006), but only the intervention group presented a significant increase in work-related well-being (<italic>F</italic><sub>2,426</sub>=8.92; <italic>P</italic>&lt;.001), as well as a significant reduction in work-related and overall stress (<italic>F</italic><sub>2,426</sub>=5.50; <italic>P</italic>=.004 and <italic>F</italic><sub>2,426</sub>=8.59; <italic>P</italic>&lt;.001, respectively). CONCLUSIONS The well-being mobile app was effective in reducing employee stress and improving well-being. CLINICALTRIAL Clinicaltrials.gov NCT02637414; https://clinicaltrials.gov/ct2/show/NCT02637414.

scholarly journals Efficacy of the Digital Therapeutic Mobile App BioBase to Reduce Stress and Improve Mental Well-Being Among University Students: Randomized Controlled Trial

10.2196/17767 ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. e17767 ◽  
Author(s):  
Sonia Ponzo ◽  
Davide Morelli ◽  
Jamie M Kawadler ◽  
Nicola Rose Hemmings ◽  
Geoffrey Bird ◽  
...  
Keyword(s):  
University Students ◽  
Controlled Trial ◽  
Well Being ◽  
Mobile App ◽  
Control Group ◽  
Full Time ◽  
Digital Version ◽  
Sustained Effects ◽  
Mental Well Being

Background University students in the United Kingdom are experiencing increasing levels of anxiety. A program designed to increase awareness of one’s present levels of well-being and suggest personalized health behaviors may reduce anxiety and improve mental well-being in students. The efficacy of a digital version of such a program, providing biofeedback and therapeutic content based on personalized well-being metrics, is reported here. Objective The aim of this study was to test the efficacy and sustained effects of using a mobile app (BioBase) and paired wearable device (BioBeam), compared with a waitlist control group, on anxiety and well-being in university students with elevated levels of anxiety and stress. Methods The study employed a randomized, waitlist-controlled trial with assessments at baseline, 2 weeks, postintervention (4 weeks), and follow-up (6 weeks). Participants were eligible if they were current full-time undergraduate students and (1) at least 18 years of age, (2) scored >14 points on the Depression, Anxiety, and Stress Scale-21 items (DASS-21) stress subscale or >7 points on the DASS-21 anxiety subscale, (3) owned an iOS mobile phone, (4) did not have any previous psychiatric or neurological conditions, (6) were not pregnant at the time of testing, and (7) were able to read and understand English. Participants were encouraged to use BioBase daily and complete at least one course of therapeutic content. A P value ≤.05 was considered statistically significant. Results We found that a 4-week intervention with the BioBase program significantly reduced anxiety and increased perceived well-being, with sustained effects at a 2-week follow-up. Furthermore, a significant reduction in depression levels was found following the 4-week usage of BioBase. Conclusions This study shows the efficacy of a biofeedback digital intervention in reducing self-reported anxiety and increasing perceived well-being in UK university students. Results suggest that digital mental health interventions could constitute a novel approach to treat stress and anxiety in students, which could be combined or integrated with existing therapeutic pathways. Trial Registration Open Science Framework (OSF.io) 2zd45; https://osf.io/2zd45/

A patient-centered mobile intervention to promote self-management and improve patient outcomes in chronic heart failure: The ManageHF4Life trial (Preprint)

2020 ◽  
Author(s):  
Michael P. Dorsch ◽  
Karen B. Farris ◽  
Brigid E. Rowell ◽  
Scott L. Hummel ◽  
Todd M. Koelling
Keyword(s):  
Heart Failure ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Self Management ◽  
Control Group ◽  
Patient Centered ◽  
Self Monitoring ◽  
Heart Failure Questionnaire

BACKGROUND Successful management of heart failure (HF) involves guideline based medical therapy as well as self-care behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE Evaluate the effectiveness of a mobile application intervention that enhances self-monitoring on health-related quality of life, self-management, and reduces HF readmissions. METHODS A single-center randomized controlled trial was performed. Patients greater than 45 years of age and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group used a mobile application (App). The intervention prompted daily self-monitoring and promoted self-management. The control group (No App) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and recurrent HF admissions. RESULTS Eighty-three patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF etiology. The App group had a reduced MLHFQ at 6 weeks (37.5 ± 3.5 vs. 48.2 ± 3.7, P=0.039) but not at 12 weeks (44.2 ± 4 vs. 45.9 ± 4, P=0.778) compared to No App. There was no effect of the App on the SCHFI at 6 or 12 weeks. The time to first HF admission was not statistically different between the App versus No App groups (HR 0.89, 95% CI 0.39-2.02, P=0.781) over 12 weeks. CONCLUSIONS The mobile application intervention improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on HF self-care. Further research is needed to enhance engagement in the application for a longer period of time and to determine if the application can reduce HF admissions in a larger study. CLINICALTRIAL NCT03149510

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