iCOPE, a multi-level, cluster randomized, 36-month, parallel-group study to assess the efficacy of HIV disclosure intervention in HIV parental disclosure among parents living with HIV in China

Objectives: Parents living with HIV who disclose their HIV status to their children could benefit from the parental HIV disclosure. However, it is also very challenging because of persistent stigma and discrimination against HIV. This report describes the study design and protocol of the “Interactive Communication with Openness, Passion, and Empowerment (iCOPE)” randomized controlled trial aimed at assisting parents living with HIV in conducting culturally and developmentally appropriate disclosure to their uninfected children in China through trainings among both parents living with HIV and healthcare providers. Methods: A total of 791 parents living with HIV with children aged between 6 and 15 years and 357 healthcare providers were randomized into either the intervention group or control group. Intervention package for parents consisted of five 2-h sessions focusing on positive coping, disclosure decision making, developing a developmentally appropriate disclosure plan, and accessing social support and post-disclosure counseling. The intervention for healthcare providers was made up of two 45-min sessions organized around two primary themes: knowledge of child cognitive development and effective parent–child communication skills in the context of parental disclosure. The control group received nutritional education of either five 2-h sessions (parents) or two 45-min sessions (healthcare providers). The outcome assessments were conducted at baseline, 6, 12, 18, 24, 30, and 36 months. Conclusion: The iCOPE study is among the first efforts to develop and evaluate a theory-based and multi-level intervention to promote culturally and developmentally appropriate parental HIV disclosure in China. It has implications for healthcare providers, social workers, and policy makers as it will provide efficacy data on how to enhance appropriate parental HIV disclosure and will shed light on developing a clinical guideline regarding parental HIV disclosure in China and other low- and middle-income countries.

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A Social Media–Based Support Group for Youth Living With HIV in Nigeria (SMART Connections): Randomized Controlled Trial (Preprint)

10.2196/preprints.18343 ◽

2020 ◽

Author(s):

Lisa Dulli ◽

Kathleen Ridgeway ◽

Catherine Packer ◽

Kate R Murray ◽

Tolulope Mumuni ◽

...

Keyword(s):

Social Support ◽

Social Media ◽

Support Group ◽

Controlled Trial ◽

Intervention Group ◽

Hiv Treatment ◽

Control Group ◽

Hiv Knowledge ◽

Youth Living With Hiv ◽

Living With Hiv

BACKGROUND Youth living with HIV (YLHIV) enrolled in HIV treatment experience higher loss to follow-up, suboptimal treatment adherence, and greater HIV-related mortality compared with younger children or adults. Despite poorer health outcomes, few interventions target youth specifically. Expanding access to mobile phone technology, in low- and middle-income countries (LMICs) in particular, has increased interest in using this technology to improve health outcomes. mHealth interventions may present innovative opportunities to improve adherence and retention among YLHIV in LMICs. OBJECTIVE This study aimed to test the effectiveness of a structured support group intervention, Social Media to promote Adherence and Retention in Treatment (SMART) Connections, delivered through a social media platform, on HIV treatment retention among YLHIV aged 15 to 24 years and on secondary outcomes of antiretroviral therapy (ART) adherence, HIV knowledge, and social support. METHODS We conducted a parallel, unblinded randomized controlled trial. YLHIV enrolled in HIV treatment for less than 12 months were randomized in a 1:1 ratio to receive SMART Connections (intervention) or standard of care alone (control). We collected data at baseline and endline through structured interviews and medical record extraction. We also conducted in-depth interviews with subsets of intervention group participants. The primary outcome was retention in HIV treatment. We conducted a time-to-event analysis examining time retained in treatment from study enrollment to the date the participant was no longer classified as active-on-treatment. RESULTS A total of 349 YLHIV enrolled in the study and were randomly allocated to the intervention group (n=177) or control group (n=172). Our primary analysis included data from 324 participants at endline. The probability of being retained in treatment did not differ significantly between the 2 study arms during the study. Retention was high at endline, with 75.7% (112/163) of intervention group participants and 83.4% (126/161) of control group participants active on treatment. HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support. Intervention group participants overwhelmingly reported that the intervention was useful, that they enjoyed taking part, and that they would recommend it to other YLHIV. CONCLUSIONS Our findings of improved HIV knowledge and high acceptability are encouraging, despite a lack of measurable effect on retention. Retention was greater than anticipated in both groups, likely a result of external efforts that began partway through the study. Qualitative data indicate that the SMART Connections intervention may have contributed to retention, adherence, and social support in ways that were not captured quantitatively. Web-based delivery of support group interventions can permit people to access information and other group members privately, when convenient, and without travel. Such digital health interventions may help fill critical gaps in services available for YLHIV. CLINICALTRIAL ClinicalTrials.gov NCT03516318; https://clinicaltrials.gov/ct2/show/NCT03516318

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Effect of a WeChat-Based Intervention (Run4Love) on Depressive Symptoms Among People Living With HIV in China: A Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/16715 ◽

2020 ◽

Vol 22 (2) ◽

pp. e16715 ◽

Cited By ~ 7

Author(s):

Yan Guo ◽

Y Alicia Hong ◽

Weiping Cai ◽

Linghua Li ◽

Yuantao Hao ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

People Living With Hiv ◽

Mhealth Intervention ◽

Randomized Controlled ◽

Hair Samples ◽

Living With Hiv

Background People living with HIV (PLWH) have high rates of depressive symptoms. However, only a few effective mental health interventions exist for this vulnerable population. Objective The aim of this study was to assess the efficacy of a WeChat-based intervention, Run4Love, with a randomized controlled trial among 300 people living with HIV and depression (PLWHD) in China. Methods We recruited PLWH from the HIV outpatient clinic in South China. Participants were screened based on the Center for Epidemiologic Studies-Depression (CES-D) scale. Those who scored 16 or higher were eligible to participate. A total of 300 eligible patients were enrolled. After obtaining informed consent from the participants, completion of a baseline survey, and collection of participants’ hair samples for measuring cortisol, the participants were randomly assigned to an intervention or a control group in a 1:1 ratio. The intervention group received the Run4Love program, delivered via the popular social media app WeChat. Cognitive behavioral stress management courses and weekly reminders of exercise were delivered in a multimedia format. Participants’ progress was monitored with timely and tailored feedback. The control group received usual care and a brochure on nutrition for PLWH. Data were collected at 3, 6, and 9 months. The primary outcome was depression, which was measured by a validated instrument. Results Participants in the intervention and control groups were comparable at baseline; about 91.3% (139/150), 88.3% (132/150), and 86.7% (130/150) participants completed the 3-, 6-, and 9-month follow-ups, respectively. At the 3-month follow-up, a significant reduction in CES-D score was observed in the intervention group (from 23.9 to 17.7 vs from 24.3 to 23.8; mean difference=−5.77, 95% CI −7.82 to −3.71; P<.001; standard effect size d=0.66). The mean changes in CES-D score from baseline to the 6- and 9-month follow-ups between the two groups remained statistically significant. No adverse events were reported. Conclusions The WeChat-based mobile health (mHealth) intervention Run4Love significantly reduced depressive symptoms among PLWHD, and the effect was sustained. An app-based mHealth intervention could provide a feasible therapeutic option for many PLWHD in resource-limited settings. Further research is needed to assess generalizability and cost-effectiveness of this intervention. Trial Registration Chinese Clinical Trial Registry ChiCTR-IPR-17012606; http://www.chictr.org.cn/showproj.aspx?proj=21019 (Archived by WebCite at https://www.webcitation.org/78Bw2vouF)

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Do Clinical Librarians Matter? The First Randomized Controlled Trial in Librarianship

Evidence Based Library and Information Practice ◽

10.18438/b8rg8f ◽

2007 ◽

Vol 2 (4) ◽

pp. 84 ◽

Cited By ~ 2

Author(s):

Jonathan Eldredge

Keyword(s):

Randomized Controlled Trial ◽

Information Seeking ◽

Controlled Trial ◽

Healthcare Providers ◽

Intervention Group ◽

Control Group ◽

Study Group ◽

Reference Services ◽

Randomized Controlled ◽

Information Requests

A review of: Marshall, Joanne Gard, and Victor R. Neufeld. “A Randomized Controlled Trial of Librarian Educational Participation in Clinical Settings.” Journal of Medical Education 56.5 (1981): 409-16. Objectives – To determine whether clinical librarian services cause healthcare providers to change their information seeking behaviors. To evaluate librarians’ educational roles for clinicians, patients, and patients’ families. Design – Randomized controlled trial. Setting – An academic, health-sciences-center, teaching hospital in Canada. Subjects – A total of eight teams, each consisting of at least eight members who represented at least three different types of health professionals. Four teams (rheumatology, obstetrics, neurology, and pediatrics) were randomized into the intervention group to receive clinical librarian services for a six-month period, and four teams (hematology, diabetic day care, pain clinic, and community psychiatry) were randomized into the control group that did not receive clinical librarian services. Methods – Two half-time clinical librarians attended the intervention groups’ rounds, clinics, and conferences identified as having educational components or where questions would likely arise related to patient care. The two clinical librarians handled 600 perceived or actual information requests, delivered 1,200 documents, and provided over 3,000 references during the twelve-month study period of September 1978 to August 1979. The typical service consisted of the clinical librarian securing one or two articles relevant to the question raised along with pertinent references placed in a “hot topics” ring binder located in the clinical wards. Healthcare providers were alerted to or reminded about the clinical librarian service through a brochure and an exhibit. The brochure also advertised the clinical librarian service to patients or their families. Approximately 24% of all information requests fielded by the clinical librarians originated from patients or their families. The remaining information requests originated from physicians (40%), allied health professionals (21%), and nurses (15%) belonging to these interdisciplinary intervention group teams. Main Results – Trained impartial interviewers conducted in-depth interviews with members of both the intervention group teams and the control group teams immediately following the first six-month study period and then again three months after the end of the study period. Following the initial six months of the study period, 67% of the members of the intervention group compared to 37% of the members of the study group used the library’s reference services. Three months after the study period had ended, 76% of the members of the intervention group compared to 49% of the members of the study group had used the reference services. The authors reported in a one-sentence page note that these findings were statistically significant beyond the .05 level as measured by chi-square and analysis of variance tests. Three months after the study period had ended, 60% of the members of the intervention group compared to 38% of the members of the study group reported rating highly the use of library resources. In addition, three months after the study period had ended, 36% of the members of the intervention group compared to 27% of the members of the study group reported rating highly the use of reference librarians. Although patients or their families were generally positive in rating the clinical librarians’ services, they proved to be a difficult population upon which to conduct a comprehensive follow-up evaluation study once patients had left the hospital. Conclusion – The authors conclude that the clinical librarian services to the four intervention groups had changed the group members’ information seeking behavior.

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A Social Media–Based Support Group for Youth Living With HIV in Nigeria (SMART Connections): Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/18343 ◽

2020 ◽

Vol 22 (6) ◽

pp. e18343 ◽

Cited By ~ 2

Author(s):

Lisa Dulli ◽

Kathleen Ridgeway ◽

Catherine Packer ◽

Kate R Murray ◽

Tolulope Mumuni ◽

...

Keyword(s):

Social Support ◽

Social Media ◽

Support Group ◽

Controlled Trial ◽

Intervention Group ◽

Hiv Treatment ◽

Control Group ◽

Hiv Knowledge ◽

Youth Living With Hiv ◽

Living With Hiv

Background Youth living with HIV (YLHIV) enrolled in HIV treatment experience higher loss to follow-up, suboptimal treatment adherence, and greater HIV-related mortality compared with younger children or adults. Despite poorer health outcomes, few interventions target youth specifically. Expanding access to mobile phone technology, in low- and middle-income countries (LMICs) in particular, has increased interest in using this technology to improve health outcomes. mHealth interventions may present innovative opportunities to improve adherence and retention among YLHIV in LMICs. Objective This study aimed to test the effectiveness of a structured support group intervention, Social Media to promote Adherence and Retention in Treatment (SMART) Connections, delivered through a social media platform, on HIV treatment retention among YLHIV aged 15 to 24 years and on secondary outcomes of antiretroviral therapy (ART) adherence, HIV knowledge, and social support. Methods We conducted a parallel, unblinded randomized controlled trial. YLHIV enrolled in HIV treatment for less than 12 months were randomized in a 1:1 ratio to receive SMART Connections (intervention) or standard of care alone (control). We collected data at baseline and endline through structured interviews and medical record extraction. We also conducted in-depth interviews with subsets of intervention group participants. The primary outcome was retention in HIV treatment. We conducted a time-to-event analysis examining time retained in treatment from study enrollment to the date the participant was no longer classified as active-on-treatment. Results A total of 349 YLHIV enrolled in the study and were randomly allocated to the intervention group (n=177) or control group (n=172). Our primary analysis included data from 324 participants at endline. The probability of being retained in treatment did not differ significantly between the 2 study arms during the study. Retention was high at endline, with 75.7% (112/163) of intervention group participants and 83.4% (126/161) of control group participants active on treatment. HIV-related knowledge was significantly better in the intervention group at endline, but no statistically significant differences were found for ART adherence or social support. Intervention group participants overwhelmingly reported that the intervention was useful, that they enjoyed taking part, and that they would recommend it to other YLHIV. Conclusions Our findings of improved HIV knowledge and high acceptability are encouraging, despite a lack of measurable effect on retention. Retention was greater than anticipated in both groups, likely a result of external efforts that began partway through the study. Qualitative data indicate that the SMART Connections intervention may have contributed to retention, adherence, and social support in ways that were not captured quantitatively. Web-based delivery of support group interventions can permit people to access information and other group members privately, when convenient, and without travel. Such digital health interventions may help fill critical gaps in services available for YLHIV. Trial Registration ClinicalTrials.gov NCT03516318; https://clinicaltrials.gov/ct2/show/NCT03516318

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Promoting the Community's Ability to Detect and Respond to Suicide Risk Through an Online Bystander Intervention Model-Informed Tool

Crisis ◽

10.1027/0227-5910/a000708 ◽

2020 ◽

pp. 1-7

Author(s):

Karien Hill ◽

Shawn Somerset ◽

Ralf Schwarzer ◽

Carina Chan

Keyword(s):

Suicide Prevention ◽

Suicide Risk ◽

Controlled Trial ◽

Intervention Group ◽

Bystander Intervention ◽

Self Report ◽

Innovative Technology ◽

Control Group ◽

Intervention Model ◽

Standard Material

Abstract. Background: The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention. Aims: The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others. Method: A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups. Results: The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all p < .001) with moderate-to-large effect sizes. Limitations: The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only. Conclusion: This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.

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Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

Africa Journal of Nursing and Midwifery ◽

10.25159/2520-5293/6232 ◽

2020 ◽

Vol 22 (1) ◽

Author(s):

Farokh Saljughi ◽

Mitra Savabi-Esfahani ◽

Shahnaz Kohan ◽

Soheila Ehsanpour

Keyword(s):

Pregnant Women ◽

Maternal Employment ◽

Controlled Trial ◽

Role Play ◽

Intervention Group ◽

Control Group ◽

Maternal Behaviour ◽

Infant Attachment ◽

Significant Difference ◽

History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

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The Effect of Reflexology on Labor Pain and Length Among Primiparous Women: A Randomized Controlled Trial

International Electronic Journal of Medicine ◽

10.31661/iejm805 ◽

2018 ◽

Vol 7 ◽

Author(s):

Azita Kamjoo

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Active Phase ◽

Labor Pain ◽

Control Group ◽

Singleton Pregnancy ◽

Group Data ◽

Significant Difference ◽

Labor Length ◽

Primiparous Women

Background: Pain control is considered as the key issue in modern midwifery. Along with medical painkillers, reflexology is viewed as a non-medical and noninvasive method. Hence, we aimed to investigate the effect of reflexology on the intensity of pain and length of labor. Materials and Methods: In this clinical trial, participants included 240 Iranian primiparous women with term and singleton pregnancy. Having a 3-4 cm cervical dilatation once they visited the hospital. Through a convenient sampling method, they were selected and then randomly divided into two groups. In the intervention group, reflexology was performed, and the intensity of pain during the active phase of labor along with the length of labor in the active phase was measured by visual analog scale (VAS) and compared with the control group. Data were analyzed using descriptive statistics, t-test, and Mann-Whitney U-test. Result: Data analysis showed a statistically significant difference between the intensity of pain in the 5-7 and 8-10 cm dilatation in the two groups (P=0.01). Moreover, the labor length in the active phase was found to be significantly shorter in the intervention group (P<0.001). Conclusion: It appears that reflexology can lead to a reduction in the pain and length of labor. Therefore, through instructing this technique, a goal of midwifery, which is reducing labor pain and its length can be achieved. Keywords: Reflexology, Labor Pain, Labor Length, Primiparous Women

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Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

10.2196/preprints.12950 ◽

2018 ◽

Author(s):

Musheer Abdulwahid Al-Jaberi ◽

Muhamad Hanafiah Juni ◽

Hayati Kadir Shahar ◽

Siti Irma Fadhilah Ismail ◽

Murad Abdu Saeed ◽

...

Keyword(s):

International Students ◽

Acculturative Stress ◽

Educational Program ◽

Public Universities ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Policy Makers ◽

Randomized Controlled ◽

Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i><.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;EncHid=&amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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

10.2196/preprints.26185 ◽

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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