scholarly journals Assessing the Effectiveness and Acceptability of a Personalized Mobile Phone App in Improving Adherence to Oral Hygiene Advice in Orthodontic Patients: Protocol for a Feasibility Study and a Randomized Controlled Trial

10.2196/18021 ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. e18021
Author(s):  
Mohammad Owaise Sharif ◽  
Jonathon Timothy Newton ◽  
Susan J Cunningham
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Mobile Phone ◽  
Mobile Phones ◽  
Orthodontic Treatment ◽  
Controlled Trial ◽  
Phase 1 ◽  
Adherence To Treatment ◽  
Randomized Controlled

Background Orthodontic treatment is a common health care intervention; treatment duration can be lengthy (2-3 years on average), and adherence to treatment advice is therefore essential for successful outcomes. It has been reported that up to 43% of patients fail to complete treatment, and there are currently no useful predictors of noncompletion. Given that the National Health Service England annual expenditure on primary-care orthodontic treatment is in excess of £200 million (US $267 million), noncompletion of treatment represents a significant inefficient use of public resources. Improving adherence to treatment is therefore essential. This necessitates behavior change, and interventions that improve adherence and are designed to elicit behavioral change must address an individual’s capability, opportunity, and motivation. Mobile phones are potentially an invaluable tool in this regard, as they are readily available and can be used in a number of ways to address an individual’s capability, opportunity, and motivation. Objective This study will assess the effectiveness and acceptability of a personalized mobile phone app in improving adherence to orthodontic treatment advice by way of a randomized controlled trial. Methods This study will be conducted in 2 phases at the Eastman Dental Hospital, University College London Hospitals Foundation Trust. Phase 1 is feasibility testing of the My Braces app. Participants will be asked to complete the user version of the Mobile Application Rating Scale. The app will be amended following analysis of the responses, if appropriate. Phase 2 is a randomized controlled trial to test the effectiveness and acceptability of the My Braces app. Results This study was approved by the London – Bloomsbury Research Ethics Committee on November 5, 2019 (reference 19/LO/1555). No patients have been recruited to date. The anticipated start date for recruitment to phase 1 is October 2020. Conclusions Given the availability, affordability, and versatility of mobile phones, it is proposed that they will aid in improving adherence to treatment advice and hence improve treatment completion rates. If effective, the applicability of this methodology to developing behavior change/modification interventions and improving adherence to treatment across health care provides an exciting opportunity. Trial Registration ClinicalTrials.gov NCT04184739; https://clinicaltrials.gov/ct2/show/NCT04184739 International Registered Report Identifier (IRRID) PRR1-10.2196/18021

scholarly journals Assessing the Effectiveness and Acceptability of a Personalized Mobile Phone App in Improving Adherence to Oral Hygiene Advice in Orthodontic Patients: Protocol for a Feasibility Study and a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Mohammad Owaise Sharif ◽  
Jonathon Timothy Newton ◽  
Susan J Cunningham
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Mobile Phone ◽  
Mobile Phones ◽  
Orthodontic Treatment ◽  
Controlled Trial ◽  
Phase 1 ◽  
Adherence To Treatment ◽  
Randomized Controlled

BACKGROUND Orthodontic treatment is a common health care intervention; treatment duration can be lengthy (2-3 years on average), and adherence to treatment advice is therefore essential for successful outcomes. It has been reported that up to 43% of patients fail to complete treatment, and there are currently no useful predictors of noncompletion. Given that the National Health Service England annual expenditure on primary-care orthodontic treatment is in excess of £200 million (US $267 million), noncompletion of treatment represents a significant inefficient use of public resources. Improving adherence to treatment is therefore essential. This necessitates behavior change, and interventions that improve adherence and are designed to elicit behavioral change must address an individual’s capability, opportunity, and motivation. Mobile phones are potentially an invaluable tool in this regard, as they are readily available and can be used in a number of ways to address an individual’s capability, opportunity, and motivation. OBJECTIVE This study will assess the effectiveness and acceptability of a personalized mobile phone app in improving adherence to orthodontic treatment advice by way of a randomized controlled trial. METHODS This study will be conducted in 2 phases at the Eastman Dental Hospital, University College London Hospitals Foundation Trust. Phase 1 is feasibility testing of the My Braces app. Participants will be asked to complete the user version of the Mobile Application Rating Scale. The app will be amended following analysis of the responses, if appropriate. Phase 2 is a randomized controlled trial to test the effectiveness and acceptability of the My Braces app. RESULTS This study was approved by the London – Bloomsbury Research Ethics Committee on November 5, 2019 (reference 19/LO/1555). No patients have been recruited to date. The anticipated start date for recruitment to phase 1 is October 2020. CONCLUSIONS Given the availability, affordability, and versatility of mobile phones, it is proposed that they will aid in improving adherence to treatment advice and hence improve treatment completion rates. If effective, the applicability of this methodology to developing behavior change/modification interventions and improving adherence to treatment across health care provides an exciting opportunity. CLINICALTRIAL ClinicalTrials.gov NCT04184739; https://clinicaltrials.gov/ct2/show/NCT04184739 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/18021

scholarly journals Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

2019 ◽  
Vol 2 ◽  
pp. 56 ◽  
Author(s):  
Mark M. Kabue ◽  
Lindsay Grenier ◽  
Stephanie Suhowatsky ◽  
Jaiyeola Oyetunji ◽  
Emmanuel Ugwa ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Phase 1 ◽  
First Year ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

scholarly journals Effectiveness of a 3-Month Mobile Phone–Based Behavior Change Program on Active Transportation and Physical Activity in Adults: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Anna Ek ◽  
Christina Alexandrou ◽  
Emmie Söderström ◽  
Patrick Bergman ◽  
Christine Delisle Nyström ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Intervention Group ◽  
Active Transportation ◽  
Randomized Controlled ◽  
Behavior Change Program

BACKGROUND Active transportation (AT; ie, walking and cycling as a mode for transportation) has been associated with decreased morbidity and mortality; however, low-cost and scalable intervention programs are lacking. OBJECTIVE The goal of the research was to determine the effectiveness of a 3-month behavior change program delivered via a mobile phone app to promote AT (TravelVu Plus) on time spent in moderate-to-vigorous physical activity (MVPA). METHODS For this 2-arm parallel randomized controlled trial, we recruited a population-based sample of 254 adults from Stockholm County who were aged 20 to 65 years and had access to a smartphone. On completion of 1-week baseline measures, the 254 participants were randomized to either the control or intervention group (1:1 ratio). Both groups had access to the standard TravelVu app (Trivector AB) for monitoring their AT for 6 months. The intervention group also received a 3-month behavior change program to promote AT (TravelVu Plus app). Assessors of outcomes were blinded to group allocation. Outcomes were objectively measured MVPA at 3 (primary) and 6 months. Secondary outcomes were AT, attitudes toward AT, and health-related quality of life at 3 and 6 months. RESULTS No effect on MVPA was observed after 3 months (<i>P</i>=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; <i>P</i>=.04]). A Bayesian analyses showed that there was a 98% probability that the intervention had any effect at 6 months, and a 63% probability that this effect was &gt;5 minute MVPA per day. CONCLUSIONS No effect on MVPA immediately after the intervention period (at 3 months) was observed; however, there was a delayed effect on MVPA (6 minutes per day) at 6 months, which corresponds to approximately 30% of the weekly MVPA recommendation. Our findings suggest that a behavior change program promoting AT delivered via an app may have a relevant effect on PA. CLINICALTRIAL ClinicalTrials.gov NCT03086837; https://clinicaltrials.gov/ct2/show/NCT03086837 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12889-018-5658-4

scholarly journals Patients and Professionals as Partners in Hypertension Care: Qualitative Substudy of a Randomized Controlled Trial Using an Interactive Web-Based System Via Mobile Phone (Preprint)

2020 ◽  
Author(s):  
Ulrika Andersson ◽  
Ulrika Bengtsson ◽  
Agneta Ranerup ◽  
Patrik Midlöv ◽  
Karin Kjellgren
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Lifestyle Changes ◽  
Hypertension Management ◽  
Web Based ◽  
Randomized Controlled ◽  
Use Of Technology ◽  
Web Based System

BACKGROUND The use of technology has the potential to support the patient´s active participation regarding treatment of hypertension. This might lead to changes in the roles of the patient and health care professional and affect the partnership between them. OBJECTIVE The aim of this qualitative study was to explore the partnership between patients and health care professionals and the roles of patients and professionals in hypertension management when using an interactive web-based system for self-management of hypertension via the patient’s own mobile phone. METHODS Focus group interviews were conducted with 22 patients and 15 professionals participating in a randomized controlled trial in Sweden aimed at lowering blood pressure (BP) using an interactive web-based system via mobile phones. The interviews were audiorecorded and transcribed and analyzed using thematic analysis. RESULTS Three themes were identified: the technology, the patient, and the professional. The technology enabled documentation of BP treatment, mainly for sharing knowledge between the patient and the professional. The patients gained increased knowledge of BP values and their relation to daily activities and treatment. They were able to narrate about their BP treatment and take a greater responsibility, inspired by new insights and motivation for lifestyle changes. Based on the patient’s understanding of hypertension, professionals could use the system as an educational tool and some found new ways of communicating BP treatment with patients. Some reservations were raised about using the system, that it might be too time-consuming to function in clinical practice and that too much measuring could result in stress for the patient and an increased workload for the professionals. In addition, not all professionals and patients had adopted the instructions regarding the use of the system, resulting in less realization of its potential. CONCLUSIONS The use of the system led to the patients taking on a more active role in their BP treatment, becoming more of an expert of their BP. When using the system as intended, the professionals experienced it as a useful resource for communication regarding BP and lifestyle. Patients and professionals described a consultation on more equal grounds. The use of technology in hypertension management can promote a constructive and person-centered partnership between patient and professional. However, implementation of a new way of working should bring benefits and not be considered a burden for the professionals. To establish a successful partnership, both the patient and the professional need to be motivated toward a new way of working. CLINICALTRIAL ClinicalTrials.gov NCT03554382; https://clinicaltrials.gov/ct2/show/NCT03554382

scholarly journals Improving Linkage to HIV Care Through Mobile Phone Apps: Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Willem Venter ◽  
Jesse Coleman ◽  
Vincent Lau Chan ◽  
Zara Shubber ◽  
Mothepane Phatsoane ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Laboratory Test ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Hiv Care ◽  
Hiv Patients ◽  
Randomized Controlled ◽  
Laboratory Results ◽  
Linkage To Hiv Care

BACKGROUND In HIV treatment program, gaps in the “cascade of care” where patients are lost between diagnosis, laboratory evaluation, treatment initiation, and retention in HIV care, is a well-described challenge. Growing access to internet-enabled mobile phones has led to an interest in using the technology to improve patient engagement with health care. OBJECTIVE The objectives of this trial were: (1) to assess whether a mobile phone–enabled app could provide HIV patients with laboratory test results, (2) to better understand the implementation of such an intervention, and (3) to determine app effectiveness in improving linkage to HIV care after diagnosis. METHODS We developed and tested an app through a randomized controlled trial carried out in several primary health care facilities in Johannesburg. Newly diagnosed HIV-positive patients were screened, recruited, and randomized into the trial as they were giving a blood sample for initial CD4 staging. Trial eligibility included ownership of a phone compatible with the app and access to the internet. Trial participants were followed for a minimum of eight months to determine linkage to HIV care indicated by an HIV-related laboratory test result. RESULTS The trial outcome results are being prepared for publication, but here we describe the significant operational and technological lessons provided by the implementation. Android was identified as the most suitable operating system for the app, due to Android functionality and communication characteristics. Android also had the most significant market share of all smartphone operating systems in South Africa. The app was successfully developed with laboratory results sent to personal smartphones. However, given the trial requirements and the app itself, only 10% of screened HIV patients successfully enrolled. We report on issues such as patient eligibility, app testing in a dynamic phone market, software installation and compatibility, safe identification of patients, linkage of laboratory results to patients lacking unique identifiers, and present lessons and potential solutions. CONCLUSIONS The implementation challenges and lessons of this trial may assist future similar mHealth interventions to avoid some of the pitfalls. Ensuring sufficient expertise and understanding of the programmatic needs by the software developer, as well as in the implementation team, with adequate and rapid piloting within the target groups, could have led to better trial recruitment. However, the majority of screened patients were interested in the study, and the app was installed successfully in patients with suitable smartphones, suggesting that this may be a way to engage patients with their health care data in future. CLINICALTRIAL ClinicalTrials.gov NCT02756949; https://clinicaltrials.gov/ct2/show/NCT02756949 (Archived by WebCite at http://www.webcitation.org/6z1GTJCNW)

scholarly journals Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

2018 ◽  
Vol 2 ◽  
pp. 56 ◽  
Author(s):  
Mark M. Kabue ◽  
Lindsay Grenier ◽  
Stephanie Suhowatsky ◽  
Jaiyeola Oyetunji ◽  
Emmanuel Ugwa ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Phase 1 ◽  
First Year ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

scholarly journals Effectiveness of a 3-Month Mobile Phone–Based Behavior Change Program on Active Transportation and Physical Activity in Adults: Randomized Controlled Trial

10.2196/18531 ◽  
2020 ◽  
Vol 8 (6) ◽  
pp. e18531 ◽  
Author(s):  
Anna Ek ◽  
Christina Alexandrou ◽  
Emmie Söderström ◽  
Patrick Bergman ◽  
Christine Delisle Nyström ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Intervention Group ◽  
Active Transportation ◽  
Randomized Controlled ◽  
Behavior Change Program

Background Active transportation (AT; ie, walking and cycling as a mode for transportation) has been associated with decreased morbidity and mortality; however, low-cost and scalable intervention programs are lacking. Objective The goal of the research was to determine the effectiveness of a 3-month behavior change program delivered via a mobile phone app to promote AT (TravelVu Plus) on time spent in moderate-to-vigorous physical activity (MVPA). Methods For this 2-arm parallel randomized controlled trial, we recruited a population-based sample of 254 adults from Stockholm County who were aged 20 to 65 years and had access to a smartphone. On completion of 1-week baseline measures, the 254 participants were randomized to either the control or intervention group (1:1 ratio). Both groups had access to the standard TravelVu app (Trivector AB) for monitoring their AT for 6 months. The intervention group also received a 3-month behavior change program to promote AT (TravelVu Plus app). Assessors of outcomes were blinded to group allocation. Outcomes were objectively measured MVPA at 3 (primary) and 6 months. Secondary outcomes were AT, attitudes toward AT, and health-related quality of life at 3 and 6 months. Results No effect on MVPA was observed after 3 months (P=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; P=.04]). A Bayesian analyses showed that there was a 98% probability that the intervention had any effect at 6 months, and a 63% probability that this effect was >5 minute MVPA per day. Conclusions No effect on MVPA immediately after the intervention period (at 3 months) was observed; however, there was a delayed effect on MVPA (6 minutes per day) at 6 months, which corresponds to approximately 30% of the weekly MVPA recommendation. Our findings suggest that a behavior change program promoting AT delivered via an app may have a relevant effect on PA. Trial Registration ClinicalTrials.gov NCT03086837; https://clinicaltrials.gov/ct2/show/NCT03086837 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-018-5658-4

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