scholarly journals Self-Monitoring by Traffic Light Color Coding Versus Usual Care on Outcomes of Patients With Heart Failure Reduced Ejection Fraction: Protocol for a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Mahin Nomali ◽  
Ramin Mohammadrezaei ◽  
Abbas Ali Keshtkar ◽  
Gholamreza Roshandel ◽  
Shahrzad Ghiyasvandian ◽  
...  
Keyword(s):  
Ejection Fraction ◽  
Controlled Trial ◽  
Self Care ◽  
The Self ◽  
Control Group ◽  
Traffic Light ◽  
Self Monitoring ◽  
Reduced Ejection Fraction ◽  
Randomized Controlled ◽  
Patients With Heart Failure

BACKGROUND Patients with heart failure (HF) reduced ejection fraction (HFrEF) have symptoms that are more severe and experience a higher rate of hospitalization compared with HF preserved ejection fraction (HFpEF) patients. However, symptom recognition cannot be made by patients based on current approaches. This problem is a barrier to effective self-care that needs to be improved by new self-monitoring instruments and strategies. OBJECTIVE This study describes a protocol for the self-monitoring daily diaries of weight and shortness of breath (SOB) based on the traffic light system (TLS). The primary objective is to compare the self-care between the intervention and control group. Comparison of HF knowledge, HF quality of life (HFQOL), and all-cause hospitalization between the 2 groups are the secondary objectives. METHODS A single-blind randomized controlled trial is being conducted at the HF clinic at Tehran Heart Center (Tehran, Iran). Sixty-eight adult patients of both genders will be enrolled during admission to HF clinic. Eligible subjects will be assigned to either the intervention or control group by a block balanced randomization method. Baseline surveys will be conducted before random allocation. Participants in the intervention group will receive an integrated package consisting of (1) HF self-care education by an Australian Heart Foundation booklet on HF, (2) regular home self-monitoring of weight and SOB, and (3) scheduled call follow-ups for 3 months. Patients in the control group will receive no intervention and they only complete monthly surveys. RESULTS This study is ongoing and is expected to be completed by the end of 2018. CONCLUSIONS This is the first trial with new self-monitoring instruments in Iran as a low and middle-income country. If the findings show a positive effect, the package will be applied in different regions with the same health care status. CLINICALTRIAL Iranian Registry of Clinical Trials IRCT2017021032476N1; https://en.irct.ir/trial/25296?revision=25296 (Archived by WebCite at http://www.webcitation.org/73DLICQL8) INTERNATIONAL REGISTERED REPOR PRR1-10.2196/9209

scholarly journals Effectiveness of a Dyadic Buddy App for Smoking Cessation: Randomized Controlled Trial

10.2196/27162 ◽  
2021 ◽  
Vol 23 (9) ◽  
pp. e27162
Author(s):  
Philipp Schwaninger ◽  
Corina Berli ◽  
Urte Scholz ◽  
Janina Lüscher
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Controlled Trial ◽  
Intervention Group ◽  
The Self ◽  
Daily Smoking ◽  
Control Group ◽  
Smoking Abstinence ◽  
Self Monitoring ◽  
Randomized Controlled

Background Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (buddy) in daily life. Objective The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. Methods A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. Results A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. Conclusions Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. Trial Registration ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7723-z

scholarly journals Effectiveness of a Dyadic Buddy App for Smoking Cessation: Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Philipp Schwaninger ◽  
Corina Berli ◽  
Urte Scholz ◽  
Janina Lüscher
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Controlled Trial ◽  
Intervention Group ◽  
The Self ◽  
Daily Smoking ◽  
Control Group ◽  
Smoking Abstinence ◽  
Self Monitoring ◽  
Randomized Controlled

BACKGROUND Tobacco smoking is one of the biggest public health threats. Smartphone apps offer new promising opportunities for supporting smoking cessation in real time. This randomized controlled trial investigated the effectiveness of an app that encourages individuals to quit smoking with the help of a social network member (<i>buddy</i>) in daily life. OBJECTIVE The objective of this study is to test the effectiveness of the SmokeFree buddy app compared with a control group with self-reported smoking abstinence and carbon monoxide (CO)–verified smoking abstinence as primary outcomes and self-reports of smoked cigarettes per day (CPD) as a secondary outcome. METHODS A total of 162 adults who smoked participated in this single-blind, two-arm, parallel-group, intensive longitudinal randomized controlled trial. Around a self-set quit date (ie, 7 days before the self-set quit date and 20 days after) and 6 months later, participants of the intervention and control groups reported on daily smoking abstinence and CPD in end-of-day diaries. Daily smoking abstinence was verified via daily exhaled CO assessments. This assessment was administered via an app displaying results of exhaled CO, thus addressing self-monitoring in both groups. In addition, participants in the intervention group used the SmokeFree buddy app, a multicomponent app that facilitates social support from a buddy of choice. RESULTS A significant reduction in CPD from baseline to the 6-month follow-up was observed among participants in both groups. Multilevel analyses revealed no significant intervention effect on self-reported and CO-verified daily smoking abstinence at the quit date and 3 weeks later. However, CPD was lower at the quit date and 3 weeks later in the intervention group than in the control group. No significant differences between groups were found for any outcome measures 6 months after the quit date. Overall, low app engagement and low perceived usefulness were observed. CONCLUSIONS Despite some encouraging short-term findings on the amount of smoking, the SmokeFree buddy app did not have beneficial effects on smoking abstinence over and above the self-monitoring control condition. Future studies should examine whether and what support processes can be effectively stimulated and how app use can be improved to better achieve this goal. CLINICALTRIAL ISRCTN Registry 11154315; https://www.isrctn.com/ISRCTN11154315 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-019-7723-z

scholarly journals Effectiveness of an educational program in nursing in the self-care of patients with heart failure: randomized controlled trial

2012 ◽  
Vol 20 (2) ◽  
pp. 296-306 ◽  
Author(s):  
María de los Ángeles Rodríguez-Gázquez ◽  
Edith Arredondo-Holguín ◽  
Richard Herrera-Cortés
Keyword(s):  
Heart Failure ◽  
Educational Program ◽  
Intervention Group ◽  
Self Care ◽  
Group Versus ◽  
The Self ◽  
Control Group ◽  
Number Needed To Treat ◽  
Randomized Controlled ◽  
Patients With Heart Failure

Unblinded randomized controlled clinical trial to evaluate the effectiveness of an educational program in nursing (educational meetings, home visits, telenursing and a printed book) in the improvement of self-care behaviors in patients with heart failure was evaluated. Thirty-three people participated in the intervention group and thirty in the control group. At the beginning and at the end of the study (ninth month), Nancy Artinian's Heart Failure Self-care Behaviors Scale was applied to assess the level of self-care. 66.0% of the intervention group versus 26.6% of the control group improved the self-care score by at least 20% (p<0.001). The Number Needed to Treat was 2.5. The findings suggest that the educational intervention has beneficial effects on the self-care behaviors of people with heart failure.

scholarly journals Potentials and barriers of using digital tools for collecting daily measurements in multiple sclerosis research

2021 ◽  
Vol 7 ◽  
pp. 205520762110555
Author(s):  
Westergaard Katrine ◽  
Signe Baattrup Ritzel ◽  
Krogh Caroline ◽  
Lynning Marie ◽  
Bergien Sofie Olsgaard ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
The Self ◽  
Digital Tools ◽  
Control Group ◽  
Unintended Effects ◽  
Self Monitoring ◽  
Randomized Controlled

Objective Digital tools offer new ways of collecting outcome data in intervention research. Little is known about the potentials and barriers of using such tools for outcome measurement in multiple sclerosis trials. This study aimed to examine reporting adherence and barriers experienced by people with multiple sclerosis in an intervention study using three different digital tools for outcome measurement. Methods This was a mixed-methods study conducted in the context of a randomized controlled trial. Data collected during the randomized controlled trial were analysed to assess reporting adherence. Twenty-three semi-structured, in-depth interviews were conducted to investigate randomized controlled trial participants’ experiences. Results Reporting adherence was high for all three measurement tools, but lower in the control group. Four main barriers were defined: (1) the self-monitoring aspect and repeated tests imbedded in the digital tools affected participants’ behavior during the randomized controlled trial. (2) Self-monitoring caused some participants to worry more about their health. (3) Passively collected data did not always correspond with participants’ own experiences, which caused them to question the validity of the collected data. (4) Daily reporting using different digital tools placed a significant burden on participants. Conclusion The study indicates a high reporting adherence using digital tools among people with multiple sclerosis. However, future studies should carefully consider the overall burden imposed on participants when taking this approach. Measures should be taken to avoid the potential unintended effects of the self-monitoring and gamification aspects of using digital tools. These measures could include passive monitoring, reducing the frequency of reporting and blinding participants to their own data.

Evaluation of a collaborative protocolized approach by community pharmacies and general medical practitioners for an Australian minor ailments scheme: study protocol for a cluster-randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Sarah Dineen-Griffin ◽  
Victoria Garcia Cardenas ◽  
Kylie Williams ◽  
Shalom Isaac Benrimoj
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Care ◽  
Cluster Randomized Controlled Trial ◽  
Control Group ◽  
Community Pharmacies ◽  
Randomized Controlled ◽  
Minor Ailments ◽  
Cluster Randomized

BACKGROUND Internationally, governments have been investing in supporting pharmacists to take on an expanded role to support self-care for health system efficiency. There is consistent evidence that minor ailment schemes (MAS) promote efficiencies within the healthcare system. The cost savings and health outcomes demonstrated in the UK and Canada opens up new opportunities for pharmacists to effect sustainable changes through MAS delivery in Australia. OBJECTIVE This trial is evaluating the clinical, economic and humanistic impact of an Australian minor ailments service (AMAS), compared with usual pharmacy care in a cluster-randomized controlled trial in Western Sydney, Australia. METHODS The cluster-randomized controlled trial design has an intervention and a control group, comparing individuals receiving a structured intervention with those receiving usual care for specific common ailments. Participants will be community pharmacies, general practices and patients located in Western Sydney Primary Health Network region. 30 community pharmacies will be randomly assigned to either intervention or control group. Each will recruit 24 patients seeking, aged 18 years or older, presenting to the pharmacy in person with a symptom-based or product-based request for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain). Intervention pharmacists will deliver protocolized care to patients using clinical treatment pathways with agreed referral points and collaborative systems boosting clinician-pharmacist communication. Patients recruited in control pharmacies will receive usual care. The co-primary outcomes are rates of appropriate use of nonprescription medicines and rates of appropriate medical referral. Secondary outcomes include self-reported symptom resolution, time to resolution of symptoms, health services resource utilization and EQ VAS. Differences in the primary outcomes between groups will be analyzed at the individual patient level accounting for correlation within clusters with generalized estimating equations. The economic impact of the model will be evaluated by cost analysis compared with usual care. RESULTS The study began in July 2018. At the time of submission, 30 community pharmacies have been recruited. Pharmacists from the 15 intervention pharmacies have been trained. 27 general practices have consented. Pharmacy patient recruitment began in August 2018 and is ongoing and monthly targets are being met. Recruitment will be completed March 31st, 2019. CONCLUSIONS This study may demonstrate the utilization and efficacy of a protocolized intervention to manage minor ailments in the community, and will assess the clinical, economic and humanistic impact of this intervention in Australian pharmacy practice. Pharmacists supporting patient self-care and self-medication may contribute greater efficiency of healthcare resources and integration of self-care in the health system. The proposed model and developed educational content may form the basis of a MAS national service, with protocolized care for common ailments using a robust framework for management and referral. CLINICALTRIAL Registered with Australian New Zealand Clinical Trials Registry (ANZCTR) and allocated the ACTRN: ACTRN12618000286246. Registered on 23 February 2018.

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

The Impact of Mobile Health use on the Self-Care of Patients with Type 2 Diabetes: A Protocol for a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Lucija Gosak ◽  
Majda Pajnkihar ◽  
Gregor Štiglic
Keyword(s):  
Type 2 Diabetes ◽  
Family Medicine ◽  
Mobile Applications ◽  
Mobile Application ◽  
Controlled Trial ◽  
Self Care ◽  
The Self ◽  
Control Group ◽  
The Impact

BACKGROUND Chronic diseases are an important public health issue worldwide and affect an individual's quality of life. Due to the alarming rise in type 2 diabetes, healthcare, which was previously largely focused primarily on diagnosis and treatment of the disease, is increasingly focused on prevention and self-care. Patients who adhere to a constant and strict treatment regimen (physical activity, diet, medication) and regularly monitor their health, maintain self-care and health, prevent exacerbation of the disease and prevent complications of diabetes (retinopathy, diabetic feet). Many innovative devices that have become increasingly present in patient health care in recent years, such as mobile applications, are available to patients to maintain consistency in monitoring their health status. Mobile applications make it easier for individuals to monitor their self-care, monitor illness, and make it easier to follow instructions regarding disease control. OBJECTIVE The study aim is to determine the impact of mobile application use on self-care in patients with type 2 diabetes. The aim of the study is also to evaluate and test the usefulness of the forDiabetes application as a tool to improve the self-care of individuals with type 2 diabetes. METHODS We will perform a double-blind randomized controlled trial. The study will include individuals over the age of 18 who have been diagnosed and have regulated type 2 diabetes, who have already received oral treatment and are being treated in family medicine practice. Also, individuals included in the study should not have any acute complications due to the consequences of type 2 diabetes. During the study, they should be able to use an Android or iOS mobile phone and a blood glucose meter. With the help of simple randomization, individuals will be divided into an intervention and a control group. Individuals in the intervention group will use the forDiabetes mobile app to monitor their self-care for type 2 diabetes. Individuals in the control group will not receive a special intervention. Data will be collected using the “Self-care of Diabetes Inventory” questionnaire and a “Brief Illness Perception Questionnaire”. Blood sugar, blood pressure, HbA1c, and weight measurements will be monitored using the calibrated instruments during the study by the nurses employed in family medicine practice. Data will be collected at the beginning of the study and after the patient visit to the family medicine practice. RESULTS The expected results as a result of using the mobile application forDiabetes are the impact on the level of self-care, the impact on the perception of the disease, blood sugar levels, blood pressure, HbA1c, and the measured body weight of the patient. CONCLUSIONS The research contributes to greater visibility and usability of mobile applications for self-care of patients with type 2 diabetes and makes aware of the possible use of innovative methods. CLINICALTRIAL NCT04999189

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