scholarly journals A Mobile Phone–Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Emily Seto ◽  
Heather Ross ◽  
Alana Tibbles ◽  
Steven Wong ◽  
Patrick Ware ◽  
...  
Keyword(s):  
Heart Failure ◽  
Controlled Trial ◽  
Hospital Readmissions ◽  
Intervention Group ◽  
Self Care ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Acute Decompensation ◽  
The Impact

BACKGROUND Patients with heart failure (HF) are at the highest risk for hospital readmissions during the first few weeks after discharge when patients are transitioning from hospital to home. Telemonitoring (TM) for HF management has been found to reduce mortality risk and hospital readmissions if implemented appropriately; however, the impact of TM targeted for patients recently discharged from hospital, for whom TM might have the biggest benefit, is still unknown. Medly, a mobile phone–based TM system that is currently being used as a standard of care for HF at a large Canadian hospital, may be an effective tool for the management of HF in patients recently discharged from hospital. OBJECTIVE The objective of the <italic>Medly-After an Incidence of acute Decompensation</italic> (Medly-AID) trial is to determine the effect of Medly on the self-care and quality of life of patients with HF who have been recently discharged from hospital after an HF-related decompensation. METHODS A multisite multimethod randomized controlled trial (RCT) will be conducted at 2 academic hospitals and at least one community hospital to evaluate the impact of Medly-enabled HF management on the outcomes of patients with HF who had been hospitalized for HF-related decompensation and discharged during the 2 weeks before recruitment. The trial will include 144 participants with HF (74 in each control and intervention groups). Control patients will receive standard of care, whereas patients in the intervention group will receive standard of care and Medly. Specifically, patients in the intervention group will record daily weight, blood pressure, and heart rate and answer symptom-related questions via the Medly app. Medly will generate automated patient self-care messages such as to adjust diuretic medications, based on the rules-based algorithm personalized to the individual patient, and send real-time alerts to their health care providers as necessary. All patients will be followed for 3 months. Primary outcome measures are self-care and quality of life as measured through the validated questionnaires Self-Care of Heart Failure Index, EQ-5D-5L, and the Kansas City Cardiomyopathy Questionnaire-12. Secondary outcome measures for this study include cost of health care services used and health outcomes. RESULTS Patient recruitment began in November 2018 at the Sunnybrook Health Sciences Centre, with a total of 35 participants recruited by July 30, 2019 (17 in the intervention group and 18 in the control group). The final analysis is expected to occur in the fall of 2020. CONCLUSIONS This RCT will be the first to assess the effectiveness of the Medly TM system for use following discharge from hospital after a HF-related decompensation. CLINICALTRIAL ClinicalTrials.gov NCT03358303; https://clinicaltrials.gov/ct2/show/NCT03358303

scholarly journals A Mobile Phone–Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized Controlled Trial

10.2196/15753 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e15753 ◽  
Author(s):  
Emily Seto ◽  
Heather Ross ◽  
Alana Tibbles ◽  
Steven Wong ◽  
Patrick Ware ◽  
...  
Keyword(s):  
Heart Failure ◽  
Controlled Trial ◽  
Hospital Readmissions ◽  
Intervention Group ◽  
Self Care ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Acute Decompensation ◽  
The Impact

Background Patients with heart failure (HF) are at the highest risk for hospital readmissions during the first few weeks after discharge when patients are transitioning from hospital to home. Telemonitoring (TM) for HF management has been found to reduce mortality risk and hospital readmissions if implemented appropriately; however, the impact of TM targeted for patients recently discharged from hospital, for whom TM might have the biggest benefit, is still unknown. Medly, a mobile phone–based TM system that is currently being used as a standard of care for HF at a large Canadian hospital, may be an effective tool for the management of HF in patients recently discharged from hospital. Objective The objective of the Medly-After an Incidence of acute Decompensation (Medly-AID) trial is to determine the effect of Medly on the self-care and quality of life of patients with HF who have been recently discharged from hospital after an HF-related decompensation. Methods A multisite multimethod randomized controlled trial (RCT) will be conducted at 2 academic hospitals and at least one community hospital to evaluate the impact of Medly-enabled HF management on the outcomes of patients with HF who had been hospitalized for HF-related decompensation and discharged during the 2 weeks before recruitment. The trial will include 144 participants with HF (74 in each control and intervention groups). Control patients will receive standard of care, whereas patients in the intervention group will receive standard of care and Medly. Specifically, patients in the intervention group will record daily weight, blood pressure, and heart rate and answer symptom-related questions via the Medly app. Medly will generate automated patient self-care messages such as to adjust diuretic medications, based on the rules-based algorithm personalized to the individual patient, and send real-time alerts to their health care providers as necessary. All patients will be followed for 3 months. Primary outcome measures are self-care and quality of life as measured through the validated questionnaires Self-Care of Heart Failure Index, EQ-5D-5L, and the Kansas City Cardiomyopathy Questionnaire-12. Secondary outcome measures for this study include cost of health care services used and health outcomes. Results Patient recruitment began in November 2018 at the Sunnybrook Health Sciences Centre, with a total of 35 participants recruited by July 30, 2019 (17 in the intervention group and 18 in the control group). The final analysis is expected to occur in the fall of 2020. Conclusions This RCT will be the first to assess the effectiveness of the Medly TM system for use following discharge from hospital after a HF-related decompensation. Trial Registration ClinicalTrials.gov NCT03358303; https://clinicaltrials.gov/ct2/show/NCT03358303 International Registered Report Identifier (IRRID) DERR1-10.2196/15753

scholarly journals Impact of simple, specific, verbal instructions on the quality of bowel preparation in hospitalized patients undergoing colonoscopy: a multicenter randomized controlled trial

2021 ◽  
Vol 09 (03) ◽  
pp. E378-E387
Author(s):  
Konstantinos Triantafyllou ◽  
Paraskevas Gkolfakis ◽  
Alexandros Skamnelos ◽  
Georgia Diamantopoulou ◽  
Athanasios Dagas ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Intervention Group ◽  
Standard Of Care ◽  
Hospitalized Patients ◽  
Verbal Instructions ◽  
Multicenter Randomized Controlled Trial ◽  
The Impact

Abstract Background and study aims Bowel preparation for colonoscopy is frequently inadequate in hospitalized patients. We explored the impact of specific verbal instructions on the quality of inpatients bowel preparation and factors associated with preparation failure. Patients and methods Randomized (1:1), two strata (mobilized vs. bedridden; 3:2) trial of consecutive inpatients from four tertiary centers, who received either specific, verbal instructions or the standard of care (SOC) ward instructions about bowel preparation. The rate of adequate bowel preparation (Boston Bowel Preparation Score [BBPS] ≥ 6, no segment < 2) comprised the primary endpoint. Mean BBPS score, good (BBPS score ≥ 7, no segment score < 2) and excellent (BBPS = 9) were among secondary endpoints. Results We randomized 300 inpatients (180 mobile) aged 71.7 ± 15.1 years in the intervention (49.7 %) and SOC (50.3 %) groups, respectively. Overall, more patients in the intervention group achieved adequate bowel preparation, but this difference did not reach statistical significance neither in the intention-to-treat [90/149 (60.4 %) vs. 82/151 (54.3 %); P = 0.29] nor in the per-protocol analysis [90/129 (69.8 %) vs. 82/132 (62.1 %); P = 0.19]. Overall BBPS score did not differ statistical significantly in the two groups, but the provision of specific verbal instructions was associated with significant higher rates of good (58.1 % vs. 43.2 %; P = 0.02) and excellent (31.8 % vs. 16.7 %; P = 0.004) bowel preparation compared to the SOC group. Administration of same-day bowel preparation and patient American Society of Anesthesiologists score > 2 were identified as risk factors for inadequate bowel preparation. Conclusions Provision of specific verbal instructions did not increase the rate of adequate bowel preparation in a population of mobilized and bedridden hospitalized patients.

scholarly journals Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial

JMIR Nursing ◽  
10.2196/20747 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e20747
Author(s):  
Mahboube Davoudi ◽  
Tahereh Najafi Ghezeljeh ◽  
Farveh Vakilian Aghouee
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Patients With Heart Failure

Background Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. Objective The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. Methods This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. Results The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (P<.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (P<.001). Conclusions Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. Trial Registration Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

Investigating bacterial decolonization for the prevention of radiation dermatitis: A randomized controlled trial and quality of life assessment.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS12137-TPS12137
Author(s):  
Karolina Mieczkowska ◽  
Alana Deutsch ◽  
Kosaku Shinoda ◽  
Johanna Daily ◽  
Nitin Ohri ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Life Assessment ◽  
Radiation Dermatitis ◽  
Low Grade ◽  
Randomized Controlled ◽  
The Impact

TPS12137 Background: Radiation dermatitis (RD) can be therapy-limiting and detrimental to quality of life for cancer patients receiving radiation therapy (RT). Bacteria play an important role in many inflammatory dermatoses. In an observational clinical study, our group discovered that nasal colonization with bacteria, specifically with Staphylococcus aureus (SA), prior to RT was an independent predictor of higher-grade RD (grade ≥2). Higher-grade RD patients were also found to have more SA on the irradiated skin after treatment. If successful, bacterial decolonization could be a safe and cost-effective method to prevent RD. Methods: This is a randomized controlled trial assessing the efficacy of universal bacterial decolonization in preventing RD. Subject inclusion criteria include patients who are aged ≥ 18 years with a diagnosis of a solid tumor of the breast or head and neck with plans for fractionated RT (≥ 15 fractions) with curative intent. Based on previous studies and power analyses, we plan to recruit a total of 80 patients. Patients in the control arm will be treated according to standard of care, including daily application of emollients and gentle bathing. In addition to standard of care, patients in the intervention arm will receive a decolonization regimen consisting of intranasal mupirocin ointment used twice daily and chlorhexidine wash used daily for 5 days prior to the initiation of RT and repeated for 5 days every other week throughout RT. Study evaluations for both groups will include bacterial cultures obtained via superficial swab from the nares, irradiated skin, and contralateral non-radiated skin performed at the beginning, middle, and end of RT. Additionally, standardized photographs of the skin at the radiated site will be performed prior to and at the completion of RT, which will be graded by a dermatologist blinded to study arm. Lastly, at identical timepoints, each patient will complete the SKINDEX-16 questionnaire, a validated quality of life (QoL) assessment. The primary endpoint is development of grade ≥ 2 RD, as compared to low-grade RD (grade 0-1), during RT. The secondary endpoint includes the impact of bacterial decolonization on QoL. Pearson’s chi square or Fisher’s exact tests will be used to compare the incidence rates of higher-grade RD between the interventional arm and control arm to assess if the intervention is associated with a lower incidence rate of higher-grade RD. Paired t-tests will be used to compare the QoL score change from baseline to after RT between the two arms. Linear regression models will be used in both analyses to adjust for covariates. Clinical trial information: NCT03883828.

scholarly journals Effect of a Smartphone-Based App on the Quality of Life of Patients With Heart Failure: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Mahboube Davoudi ◽  
Tahereh Najafi Ghezeljeh ◽  
Farveh Vakilian Aghouee
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Clinical Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Patients With Heart Failure

BACKGROUND Patients with heart failure have low quality of life because of physical impairments and advanced clinical symptoms. One of the main goals of caring for patients with heart failure is to improve their quality of life. OBJECTIVE The aim of this study was to investigate the effect of the use of a smartphone-based app on the quality of life of patients with heart failure. METHODS This randomized controlled clinical trial with a control group was conducted from June to October 2018 in an urban hospital. In this study, 120 patients with heart failure hospitalized in cardiac care units were randomly allocated to control and intervention groups. Besides routine care, patients in the intervention group received a smartphone-based app and used it every day for 3 months. Both the groups completed the Minnesota Living with Heart Failure Questionnaire before entering the study and at 3 months after entering the study. Data were analyzed using the SPSS software V.16. RESULTS The groups showed statistically significant differences in the mean scores of quality of life and its dimensions after the intervention, thereby indicating a better quality of life in the intervention group (<i>P</i>&lt;.001). The effect size of the intervention on the quality of life was 1.85 (95% CI 1.41-2.3). Moreover, the groups showed statistically significant differences in the changes in the quality of life scores and its dimensions (<i>P</i>&lt;.001). CONCLUSIONS Use of a smartphone-based app can improve the quality of life in patients with heart failure. The results of our study recommend that digital apps be used for improving the management of patients with heart failure. CLINICALTRIAL Iranian Registry of Clinical Trials IRCT2017061934647N1; https://www.irct.ir/trial/26434

A single educational intervention on heart failure self-care: Extended follow-up from a multisite randomized controlled trial

2020 ◽  
pp. 147451512094164 ◽  
Author(s):  
Hiba Deek ◽  
Samar Noureddine ◽  
Dalia Allam ◽  
Phillip J Newton ◽  
Patricia M Davidson
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trial ◽  
Educational Intervention ◽  
Family Study ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Index Admission ◽  
Randomized Controlled ◽  
The Family

Background: Heart failure outcomes remain poor, and little is known about the causes and predictors of these outcomes in Lebanon. Aim: The purpose of this article is to report the causes and predictors of the 6- and 12-month readmission and mortality of previously recruited patients to the Family focused Approach to iMprove Heart Failure care In LebanonQualitY intervention (FAMILY) study. Methods: A multi-site block randomized controlled trial in three tertiary medical centers in Beirut. Initially, participants were randomized to either the control or the intervention group. The latter group, with their family caregivers, received heart failure self-care resources and an educational intervention on self-care and symptom management during their index admission. Participants from the FAMILY study were followed up with through phone calls for readmission and mortality at 6 and 12 months following their hospital discharge. Results: A total of 218 (85%) patients were followed up with for this evaluation. There was a significant difference between the intervention group and the control group in terms of mortality at 6 months ( n=18 (16%) versus n=36 (33%); p<0.05) and 12 months ( n=29 (26%) versus n=45 (42%); p<0.05) post the index discharge. Mortality at 6 and 12 months was associated with aging, lower body mass index scores and readmission at 30 days post the index admission. Results of a logistic regression for mortality at 6 months showed hypertensive etiology of heart failure and 30-day readmission to be the only significant predictors. Conclusion: A single session intervention was associated with lower mortality, even after an extended period of time, possibly mediated by other variables. Future studies should be powered for such outcomes while also addressing the cultural needs and literacy levels of the patients using multi-session trials and more frequent follow-ups.

scholarly journals Effect of Illness Perception Correction - Based Educational Program on Quality Of Life and Self- Care in Patients with Heart Failure: a Randomized Controlled Trial

2019 ◽  
Vol 8 (2) ◽  
pp. 89-93 ◽  
Author(s):  
Ali Sadeghi Akbari ◽  
Mohammad Ali Cheraghi ◽  
Anoushiravan kazemnejad ◽  
Mahin Nomali ◽  
Maasumeh Zakerimoghadam
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Randomized Controlled Trial ◽  
Educational Program ◽  
Controlled Trial ◽  
Illness Perception ◽  
Self Care ◽  
Control Group ◽  
Randomized Controlled

Introduction: Because of the chronic nature of Heart Failure (HF), low Quality of Life (QoL) and poor self-care are prevalent among patients with HF. Thus, the aim of this study was to evaluate the effect of illness perception correction- based educational program on QoL,and self- care in patients with HF. Methods: In this randomized controlled trial, 78 eligible patients were included in the study from Rajaei Heart Center (Tehran, Iran) and randomly assigned into intervention and control group with 1:1 allocation ratio. The intervention was a combination of illness perception correction- based education program (30- minute sessions over 3 consecutive days) and 10-minute phone calls made once a week in the course of 8 weeks. The control group received usual care. The primary outcome was quality of life and secondary outcomes were self- care and illness- perception which were measured at baseline and at the end of the study. SPSS version 13 was used for the analysis. Results: Out of 76 eligible patients, 70 patients with HF finished the study. Although the mean of quality of life, self-care, and illness perception were not different at baseline, QoL (45.2 (8.3) VS 66.8 (15.4); P<0.001), self-care (18.5 (4.5) VS 37.1 (7.2); P<0.001), and illness- perception (183.6 (8.4) VS 151.2 (24.5); P<0.001) improved following the program in the intervention group in comparison to the control group. Conclusion: According to the study findings, this program can be applied by nurses for patients with HF as a discharge plan in order to improve their QoL, self-care, and their illness perception.

scholarly journals Effect of an orientation group for patients with chronic heart failure: randomized controlled trial

2018 ◽  
Vol 25 (0) ◽  
Author(s):  
Cristina Silva Arruda ◽  
Juliana de Melo Vellozo Pereira ◽  
Lyvia da Silva Figueiredo ◽  
Bruna dos Santos Scofano ◽  
Paula Vanessa Peclat Flores ◽  
...  
Keyword(s):  
Heart Failure ◽  
Randomized Controlled Trial ◽  
Chronic Heart Failure ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Care ◽  
Control Group ◽  
Adherence To Treatment ◽  
Randomized Controlled ◽  
Orientation Group

ABSTRACT Objective: To evaluate the effect of the orientation group on therapeutic adherence and self-care among patients with chronic heart failure. Method: Randomized controlled trial with 27 patients with chronic heart failure. The intervention group received nursing consultations and participated in group meetings with the multi-professional team. The control group only received nursing consultations in a period of four months. Questionnaires validated for use in Brazil were applied in the beginning and in the end of the study to assess self-care outcomes and adherence to treatment. Categorical variables were expressed through frequency and percentage distributions and the continuous variables through mean and standard deviation. The comparison between the initial and final scores of the intervention and control groups was done through the Student’s t-test. Results: The mean adherence in the intervention group was 13.9 ± 3.6 before the study and 4.8 ± 2.3 after the study. In the control group it was 14.2 ± 3.4 before the study and 14.7 ± 3.5 after the study. The self-care confidence score was lower after the intervention (p=0.01). Conclusion: The orientation group does not improve adherence to treatment and self-care management and maintenance and it may reduce confidence in self-care. Registry REBEC RBR-7r9f2m.

scholarly journals The impact of pharmacist/physician care on quality of life in elderly heart failure patients: results of the PHARM‐CHF randomized controlled trial

2020 ◽  
Vol 7 (6) ◽  
pp. 3310-3319
Author(s):  
Martin Schulz ◽  
Nina Griese‐Mammen ◽  
Pia M. Schumacher ◽  
Stefan D. Anker ◽  
Friedrich Koehler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Heart Failure Patients ◽  
Randomized Controlled ◽  
Physician Care ◽  
The Impact

scholarly journals Effectiveness of motivational interviewing on anxiety, depression, sleep quality and quality of life in heart failure patients: secondary analysis of the MOTIVATE-HF randomized controlled trial

2021 ◽  
Author(s):  
Paola Rebora ◽  
Valentina Spedale ◽  
Giuseppe Occhino ◽  
Michela Luciani ◽  
Rosaria Alvaro ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Controlled Trial ◽  
Self Care ◽  
Anxiety And Depression ◽  
Randomized Controlled ◽  
Anxiety Depression

Abstract Purpose Anxiety, depression, poor sleep quality and lower quality of life (QOL) are associated with worse outcomes in heart failure (HF) patients. Motivational interview (MI) has been effective in different patient populations to promote self-care. However, its effect on anxiety, depression, sleep quality and QOL in HF patients is unknown. The aim of this study was to evaluate the effect of MI on anxiety, depression, sleep quality and QOL over 12 months from the intervention. Methods This was a planned, secondary outcome analysis of the MOTIVATE-HF study, a three-arm randomized controlled trial (1:1:1) evaluating the effect of MI in improving self-care in HF patients. In Arm 1, the patient received MI, while in Arm 2, the patient and the caregiver received MI. Arm 3, the control group, received standard treatment. Endpoints were evaluated with the Hospital Anxiety and Depression Scale (HADS), the Pittsburgh Sleep Quality Index (PSQI), the 12-Item Short-Form Health Survey (SF-12) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) every three months for one year. Results We enrolled and randomized 510 HF patient and caregiver dyads (155 dyads in Arm 1, 177 dyads in Arm 2, and 178 dyads in Arm 3). A total of 238 HF patients and 235 caregivers completed the 12-month trial. No significant changes were seen in anxiety, depression and sleep quality over time among the three study arms, but disease-specific QOL improved in the intervention groups, especially in Arm 2. Conclusion Clinicians may want to include both patients and caregivers when providing MI interventions. Further research is needed to investigate the required intensity of MI to be effective on sleep quality, anxiety and depression (ClinicalTrials.gov Identifier: NCT02894502).

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