scholarly journals A text-messaging study to help cope with social distancing: clinical trial protocol for the Stay Well at Home study (Preprint)

2020 ◽  
Author(s):  
Caroline Astrid Figueroa ◽  
Rosa Hernandez-Ramos ◽  
Claire Elizabeth Boone ◽  
Laura Gómez-Pathak ◽  
Vivian Yip ◽  
...  

BACKGROUND Social distancing is a crucial intervention to slow down person-to-person transmission of COVID-19. However, social distancing has negative consequences including increases in depression and anxiety. Digital interventions, like text-messaging, can provide accessible support on a population wide scale. We developed text messages in English and Spanish to help individuals manage their depressive mood and anxiety during the COVID-19 pandemic. OBJECTIVE In a two-arm randomized controlled trial we aim to examine the effect of our 60 days text-messaging intervention. Additionally, we aim to assess if the use of machine learning to adapt the messaging frequency and content improves the effectiveness of the intervention. Finally, we will examine the differences in daily mood ratings between the message categories and time windows. METHODS The messages are designed within two different categories: behavioral activation and coping skills. Participants will be randomized into 1) a random messaging arm, where message category and timing will be chosen with equal probabilities, and 2) a reinforcement-learning arm, with a learned decision mechanism for choosing the messages. Participants in both arms will receive one message per day within three different time windows and will be asked to provide their mood rating 3 hours later. We will compare self-reported daily mood ratings, self-reported Patient Health Questionnaire depression scale 8-item (PHQ-8) and Generalized Anxiety Disorder 7-item (GAD-7) at baseline and at intervention completion. RESULTS The Institutional Review Board at the University of California Berkeley approved this study (CPHS: 2020-04-13162) in April 2020. Data collection runs from April 2020 to April 2021. As of August 24th 2020, we have enrolled 229 participants. We plan to submit manuscripts describing the main results of the trial and results from the micro-randomized trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings. CONCLUSIONS Results will contribute to our knowledge of effective psychological tools to alleviate the negative effects of social distancing, and the benefit of using machine learning to personalize digital mental health interventions. CLINICALTRIAL Clinicaltrials.gov: NCT04473599; pre-results.

2021 ◽  
Author(s):  
Adrian Aguilera ◽  
Rosa Hernandez-Ramos ◽  
Alein Yaritza Haro ◽  
Claire Elizabeth Boone ◽  
Tiffany Luo ◽  
...  

BACKGROUND Social distancing and stay-at-home orders are critical interventions to slow down person-to-person transmission of COVID-19. While these societal changes help to contain the pandemic, they also have unintended negative consequences, including anxiety and depression. We developed StayWell, a daily skills-based SMS text messaging program, to mitigate COVID-19 related depression and anxiety symptoms among people who speak English and Spanish in the United States. OBJECTIVE This paper describes the changes in the anxiety and depression levels of participants in the StayWell program after 60 days of exposure to skills-based SMS text messages. METHODS We used self-administered, empirically supported web-based questionnaires to assess the demographic and clinical characteristics of StayWell participants. Anxiety and depression were measured using the 2-item Generalized Anxiety Disorder (GAD-2) scale and the 8-item Patient Health Quesstionanire-8 (PHQ-8) scale at baseline and 60-day timepoints. We used paired t-tests to detect the change in PHQ-8 and GAD-2 scores from baseline to follow-up measured 60 days later. RESULTS The analytic sample includes 193 participants who completed both the baseline and 60-day exit questionnaires. At the 60-day time point, there were statistically significant reductions in both PHQ-8 and GAD-2 scores from baseline. We found an average reduction of -1.72 (95% CI: -2.35, -1.09) in PHQ-8 scores and -0.48 (95% CI: -0.71, -0.25) in GAD-2 scores. This translated to an 18.5% and 17.2% reduction in mean PHQ-8 scores and GAD-2, respectively. CONCLUSIONS StayWell is a low-intensity, cost-effective, and accessible population-level mental health intervention. Participation in StayWell focused on COVID-19 mental health coping skills and was related to improved depression and anxiety symptoms. In addition to improvements in outcomes, we found high levels of engagement during the 60-day intervention period. Text messaging interventions could serve as an important public health tool for disseminating strategies to manage mental health. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT04473599 INTERNATIONAL REGISTERED REPORT RR2-10.2196/23592


BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e023545 ◽  
Author(s):  
Jessica Stevenson ◽  
Katrina L Campbell ◽  
Mark Brown ◽  
Jonathan Craig ◽  
Kirsten Howard ◽  
...  

IntroductionManaging nutrition is critical for reducing morbidity and mortality in patients on haemodialysis but adherence to the complex dietary restrictions remains problematic. Innovative interventions to enhance the delivery of nutritional care are needed. The aim of this phase II trial is to evaluate the feasibility and effectiveness of a targeted mobile phone text messaging system to improve dietary and lifestyle behaviours in patients on long-term haemodialysis.Methods and analysisSingle-blinded randomised controlled trial with 6 months of follow-up in 130 patients on haemodialysis who will be randomised to either standard care or KIDNEYTEXT. The KIDNEYTEXT intervention group will receive three text messages per week for 6 months. The text messages provide customised dietary information and advice based on renal dietary guidelines and general healthy eating dietary guidelines, and motivation and support to improve behaviours. The primary outcome is feasibility including recruitment rate, drop-out rate, adherence to renal dietary recommendations, participant satisfaction and a process evaluation using semistructured interviews with a subset of purposively sampled participants. Secondary and exploratory outcomes include a range of clinical and behavioural outcomes and a healthcare utilisation cost analysis will be undertaken.Ethics and disseminationThe study has been approved by the Western Sydney Local Health District Human Research Ethics Committee—Westmead. Results will be presented at scientific meetings and published in peer-reviewed publications.Trial registration numberACTRN12617001084370; Pre-results.


2020 ◽  
Author(s):  
Emily S Ross ◽  
Brodie M Sakakibara ◽  
Martha H Mackay ◽  
David GT Whitehurst ◽  
Joel Singer ◽  
...  

BACKGROUND Acute coronary syndrome (ACS) is a leading cause of hospital admission in North America. Many patients with ACS experience challenges after discharge that impact their clinical outcomes and psychosocial well-being. Text messaging has the potential to provide support to patients during this post-discharge period. OBJECTIVE This study pilot-tested a 60-day text-messaging intervention (Txt2Prevent) for patients with ACS. The primary objective was to compare self-management domains between usual care and usual care plus Txt2Prevent. The secondary objectives were to compare medication adherence, health-related quality of life, self-efficacy, and healthcare resource use between groups. The third objective was to assess the feasibility of the study protocol and the acceptability of the intervention. METHODS This was a randomized controlled trial with blinding of outcome assessors. We recruited 76 patients with ACS from St. Paul’s Hospital in Vancouver, Canada and randomized them to one of two groups within seven days of discharge. The Txt2Prevent program included automated one-way text messages about follow-up care, self-management and healthy living. Data was collected during the index admission and at 60-days after randomization. The primary outcome was measured with the Health Education Impact Questionnaire (heiQ). Other outcomes included the EQ-5D-5L, EQ visual analogue scale, Sullivan Cardiac Self-Efficacy Scale, Morisky Medication Adherence Scale and self-reported healthcare resource use. Analyses of covariance were used to test the effect of group assignment on follow-up scores (controlling for baseline) and were considered exploratory in nature. Feasibility was assessed with descriptive characteristics of the study protocol. Acceptability was assessed with two survey questions and semi-structured interviews. RESULTS There were no statistically significant differences between the groups for the heiQ domains (adjusted mean difference: health directed activity: –0.13 [95% confidence interval (CI): –0.39-0.13]; positive and active engagement in life: 0.03 [95% CI: –0.19-0.25]; emotional distress: 0.04 [95% CI: –0.22-0.29]; self-monitoring and insight: 0.14 [95% CI: –0.33-0.05]; constructive attitudes and approaches: –0.10 [95% CI: –0.36- 0.17]; skill technique and acquisition: 0.05 [95% CI: –0.18-0.27]; social integration and support: –0.12 [95% CI: –0.34-0.19]; health services navigation: –0.05 [95% CI: –0.29-0.19]). For the secondary outcomes, there were no statistically significant differences in adjusted analyses except in one self-efficacy domain (‘Total Plus’), where the Txt2Prevent group had lower scores (mean difference: –0.36 [95% CI: –0.66 to -0.50]). The study protocol was feasible although recruitment took longer than expected. Over 90% of participants reported they were satisfied with the program. CONCLUSIONS The Txt2Prevent study was feasible to implement; however, although exploratory, there were no differences between the two groups in adjusted analyses except for one self-efficacy domain. As the intervention appeared acceptable, there is potential in using text messages in this context. The design of the intervention may need to be reconsidered to have more impact on outcome measures. CLINICALTRIAL ClinicalTrials.gov NCT02336919 INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.6968


2021 ◽  
Author(s):  
Celine Larkin ◽  
Jessica Wijesundara ◽  
Hoa L Nguyen ◽  
Duc Anh Ha ◽  
Anh Vuong ◽  
...  

BACKGROUND Tobacco kills more than 8 million people each year, mostly in low- and middle-income countries. In Vietnam, 1 in every 2 male adults smokes tobacco. Vietnam has set up telephone Quitline counseling that is available to all smokers, but it is underused. We previously developed an automated and effective motivational text messaging system to support smoking cessation among US smokers. OBJECTIVE The aim of this study is to adapt the aforementioned system for rural Vietnamese smokers to promote cessation of tobacco use, both directly and by increasing the use of telephone Quitline counseling services and nicotine replacement therapy. Moreover, we seek to enhance research and health service capacity in Vietnam. METHODS We are testing the effectiveness of our culturally adapted motivational text messaging system by using a community-based randomized controlled trial design (N=600). Participants were randomly allocated to the intervention (regular motivational and assessment text messages) or control condition (assessment text messages only) for a period of 6 months. Trial recruitment took place in four communes in the Hung Yen province in the Red River Delta region of Vietnam. Recruitment events were advertised to the local community, facilitated by community health workers, and occurred in the commune health center. We are assessing the impact of the texting system on 6-month self-reported and biochemically verified smoking cessation, as well as smoking self-efficacy, uptake of the Quitline, and use of nicotine replacement therapy. In addition to conducting the trial, the research team also provided ongoing training and consultation with the Quitline during the study period. RESULTS Site preparation, staff training, intervention adaptation, participant recruitment, and baseline data collection were completed. The study was funded in August 2017; it was reviewed and approved by the University of Massachusetts Medical School Institutional Review Board in 2017. Recruitment began in November 2018. A total of 750 participants were recruited from four communes, and 700 (93.3%) participants completed follow-up by March 2021. An analysis of the trial results is in progress; results are expected to be published in late 2022. CONCLUSIONS This study examines the effectiveness of mobile health interventions for smoking in rural areas in low- and middle-income countries, which can be implemented nationwide if proven effective. In addition, it also facilitates significant collaboration and capacity building among a variety of international partners, including researchers, policy makers, Quitline counselors, and community health workers. CLINICALTRIAL ClinicalTrials.gov NCT03567993; https://clinicaltrials.gov/ct2/show/NCT03567993. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30947


2019 ◽  
Author(s):  
Dickson Shey Nsagha ◽  
Vincent Verla Siysi ◽  
Same Ekobo ◽  
Thomas Obinchemti Egbe ◽  
Odette Dzemo Kibu

BACKGROUND Incomplete adherence to antiretroviral therapy (ART) is one of the factors that contribute to HIV drug resistance, and it is a major problem for the public health system in controlling the HIV pandemic. There is emerging evidence that SMS can play an important role in health care delivery among patients with HIV on ART, especially in resource-limited settings. OBJECTIVE This paper aims to assess the impact of two-way and one-way SMS text messaging on adherence to HIV treatment. We hypothesized that sending weekly text messages through the one-way and two-way SMS text messaging approach will improve adherence to ART among patients with HIV and improve associated clinical outcomes (quality of life). METHODS A randomized controlled trial is being carried out among participants with HIV who have been on ART for at least one month from an accredited treatment center, namely the Buea Regional Hospital and Kumba District Hospital of South West Region, Cameroon. Participants with HIV, both male and female, aged 21 years and older make up a sample size of 207. The interventions involved the use of mobile phone text messages. Before commencing the intervention, a focus group discussion was carried out among the participants to understand their perception about the use of SMS-based interventions to improve adherence. A total of 246 participants were randomized to receive either a one-way text message (SMS sent to a recipient without recipient sending a reply) or two-way text message (SMS sent to a recipient and recipient sends a reply) or the control (no SMS, only standard care). Data on adherence and quality of life were collected at baseline and after 6 months and will be analyzed using SPSS version 21, while qualitative data will be analyzed using Atlas.ti 7.5. RESULTS Data collection began in September 2019 with focus group discussions and baseline data collection. After 1 month of baseline data collection, the intervention began in October 2019, and postintervention data were collected after 6 months (March 2020). At the end of the study, we will be able to understand the perception of patients toward SMS text messaging–based interventions and also assess the impact of one-way and two-way SMS text messages on treatment adherence among patients with HIV and on associated clinical outcomes (quality of life). CONCLUSIONS The impact of SMS text messaging varies across different settings. The results from this study will determine the perception of patients toward an SMS text messaging–based intervention and its impact on adherence to ART. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16127


2017 ◽  
Author(s):  
Richard Fletcher ◽  
Chris May ◽  
John Attia ◽  
Craig Franklin Garfield ◽  
Geoff Skinner

BACKGROUND Recent estimates indicating that approximately 10% of fathers experience Paternal Perinatal Depression (PPND) and the increasing evidence of the impact of PPND on child development suggest that identifying and assisting distressed fathers is justified on public health grounds. However, addressing new fathers’ mental health needs requires overcoming men’s infrequent contact with perinatal health services and their reluctance to seek help. Text-based interventions delivering information and support have the potential to reach such groups in order to reduce the impact of paternal perinatal distress and to improve the wellbeing of their children. While programs utilising mobile phone technology have been developed for mothers, fathers have not been targeted. Since text messages can be delivered to individual mobile phones to be accessed at a time that is convenient, it may provide a novel channel for engaging with “hard-to-reach” fathers in a critical period of their parenting. OBJECTIVE The study will test the efficacy of SMS4dads, a text messaging program designed specifically for fathers including embedded links to online information and regular invitations (Mood Tracker) to monitor their mood, in order to reduce self-reported depression, anxiety and stress over the perinatal period. METHODS A total of 800 fathers-to-be or new fathers from within Australia will be recruited via the SMS4dads website and randomized to the intervention or control arm. The intervention arm will receive 14 texts per month addressing fathers’ physical and mental health, their relationship with their child, and coparenting with their partner. The control, SMS4health, delivers generic health promotion messages twice per month. Messages are timed according to the babies’ expected or actual date of birth and fathers can enroll from 16 weeks into the pregnancy until their infant is 12 weeks of age. Participants complete questionnaires assessing depression, anxiety, stress, and alcohol at baseline and 24 weeks postenrolment. Measures of coparenting and parenting confidence are also completed at baseline and 24 weeks for postbirth enrolments. RESULTS Participant were recruited between October 2016 and September 2017. Follow-up data collection has commenced and will be completed in March 2018 with results expected in June 2018. CONCLUSIONS This study’s findings will assess the efficacy of a novel text-based program specifically targeting fathers in the perinatal period to improve their depression, anxiety and distress symptoms, coparenting quality, and parenting self-confidence. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12616000261415; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=370085 (Archived by WebCite at http://www.webcitation.org/6wav55wII).


2019 ◽  
Author(s):  
Panpan Zhai ◽  
Khezar Hayat ◽  
Wenjing Ji ◽  
Qian Li ◽  
Li Shi ◽  
...  

BACKGROUND Hypertension is one of the leading risk factors for ischemic heart diseases, and high rates of hypertension prevalence have either remained the same or increased in developing countries in recent years. Unfortunately, about 20% to 50% of patients with chronic diseases have been nonadherent to their drug therapy. SMS text messaging and pharmacy student–led consultations have the potential to help patients manage their blood pressure (BP). OBJECTIVE The aim of this study was to assess the effectiveness, feasibility, and acceptability of SMS text messaging and consultation to manage the BP of Chinese patients with hypertension. METHODS We conducted a two-arm cluster randomized controlled trial among patients with hypertension in Xi’an City, Shaanxi Province, China, and recruited 384 patients from 8 community health care centers. Patients were randomized into an intervention group to receive SMS text messages and consultations or into a control group to receive usual care for 3 months. We sent SMS text messages at 3-day intervals and collected data at baseline (including demographics, clinical outcomes, medication complexity, side effects, patient behavior, knowledge about hypertension, BP, and medication adherence) and the 3-month follow-up (including BP, medication adherence, and knowledge about hypertension). RESULTS We assessed 445 patients with hypertension and excluded 61 patients who were not eligible or who had not filled out their questionnaires. The mean age of the patients was 68.5 (SD 7.9) years in the intervention group and 69.4 (SD 9.7) years in the control group, and the sample was primarily female (265/384, 69.0%). Patients in the intervention group showed significant improvements in systolic BP (SBP; mean 134.5 mm Hg, SD 15.5 mm Hg vs mean 140.7 mm Hg, SD 15.2 mm Hg; <i>P</i>=.001), medication adherence (mean 7.4, SD 1.2 vs mean 7.0, SD 1.3; <i>P</i>=.04), and knowledge about hypertension (mean 6.3, SD 0.9 vs mean 5.9, SD 1.2; <i>P</i>=.004) compared with those in the control group. In measures of diastolic BP (DBP), the two arms showed nonsignificant improvements (mean 78.2 mm Hg, SD 9.0 mm Hg vs mean 77.2 mm Hg, SD 10.3 mm Hg; <i>P</i>=.06). In total, 176 patients had controlled BP at the 3-month follow-up (98 patients in the intervention group vs 78 patients in the control group), but it was nonsignificant (<i>P</i>=.08). CONCLUSIONS The use of SMS text messaging and consultation to manage SBP and improve medication adherence is effective, feasible, and acceptable among Chinese patients with hypertension, although a significant difference was not observed with regard to DBP. It is important to maximize the potential of SMS text messaging and consultation by increasing the feasibility and acceptance of mobile interventions and conduct a cost-effectiveness analysis on this method. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR1900026862; http://www.chictr.org.cn/showproj.aspx?proj=42717.


2015 ◽  
Vol 12 (6) ◽  
pp. 756-763 ◽  
Author(s):  
Nancy M. Gell ◽  
Danielle D. Wadsworth

Background:The study evaluated the effects of a text message intervention on physical activity in adult working women.Methods:Eightyseven participants were randomized to an intervention (n = 41) or control group (n = 46). Pedometer step counts and measures of self-efficacy were collected at baseline, 12 weeks, and 24 weeks. Intervention participants received approximately 3 text messages per week that were motivational, informational, and specific to performing physical activity.Results:ANCOVA results showed a significant difference between groups for mean steps per day at 12 weeks (6540.0 vs. 5685.0, P = .01) and no significant difference at 24 weeks (6867.7 vs. 6189.0, P = .06). There was no change in mean step counts during or after the intervention compared with baseline. There was a significant difference between groups for mean self-efficacy scores at 12 weeks (68.5 vs. 60.3, P = .02) and at 24 weeks (67.3 vs. 59.0, P = .03).Conclusion:Intervention participants had higher step counts after 12 and 24 weeks compared with a control group; however, the difference was significant only at the midpoint of the intervention and was attributable to a decrease in steps for the control group. Text messaging did not increase step counts but may be a cost-effective tool for maintenance of physical activity behavior.


Author(s):  
Lorien C Abroms ◽  
Keng-Chieh Wu ◽  
Nandita Krishnan ◽  
Michael Long ◽  
Sarah Belay ◽  
...  

Abstract Background Automated text messaging programs have been studied as a treatment tool, but have not been studied as an outreach tool to increase the reach of smoking cessation treatment. Methods Two distinct text messaging programs were developed. One was aimed at connecting smokers to quitline phone counseling via text message (Text4Coach (T4C)) and the other was aimed at connecting smokers to a smoking cessation text messaging program (Text&Quit (T&Q)). Adult daily smokers with Medicaid insurance (N=80) were recruited from the Emergency Department at an urban hospital and randomized to T4C or T&Q. The primary outcome was program reach. Results Outreach text messages were found to have moderately high uptake, with the majority of participants (63.8%) opting into their assigned tobacco treatment program and younger and female participants more likely to opt in (p&lt;.01). Receipt of the treatment portion of the program differed among the programs with 67.5% of T&Q receiving the treatment program and 27.5 % of T4C receiving the program (p&lt;.001). Most participants across both groups replied to at least 1 message (71.3%) and very few unsubscribed from the service over the 3 week trial. The majority of participants reported overall satisfaction with their program (63.8%), found it helpful for quitting smoking (60.0%) and would recommend the program to a friend (62.5%). Overall, 11 (13.8 %) participants reported being abstinent from smoking for the past 7 days at follow-up, with no differences between groups. Conclusion Outreach text messages were found to have moderately high reach among Medicaid smokers. Larger trials are needed to evaluate the impact of such programs on helping low-income smokers quit.


2019 ◽  
Author(s):  
Anika Rouf ◽  
Monica Nour ◽  
Margaret Allman-Farinelli

BACKGROUND Calcium is an important nutrient for the attainment of peak bone mass during adolescence and young adulthood. However, these life phases are characterized as hard to reach for health promotion. Social media platforms offer a promising channel as they are relatively low cost but used ubiquitously by youth. OBJECTIVE The aim of the CAlcium Nutrition-Dietary Opportunities (CAN-DO) study was to conduct a randomized controlled trial to test the effectiveness of Facebook alone or with text messaging as channels to deliver a theory-based program to encourage optimal calcium intake. METHODS The intervention was a 3-arm parallel trial. Young adults aged 18 to 25 years were recruited through university and social media for a 6-week trial. Participants were randomized to 1 of the 3 arms (ie, Facebook posts, Facebook posts plus text messages, and control group that received an electronic leaflet containing information on calcium intake). The primary outcome was change in intake of milk and other calcium-rich foods, and secondary outcomes were knowledge, self-efficacy, motivation, and habit formation concerning calcium-rich foods. Changes were assessed before and after the intervention, and the differences in change between groups were compared using multivariate regression models with multiple imputations for missing data. RESULTS A total of 211 participants (64/211, 30.3% males) participated (mean age 21.4 years, SD 2.1) in this study. At the end of the program, no increase in milk intake (odds ratio [OR] 1.51, 95% CI 0.61-3.75 Facebook; OR 1.77, 95% CI 0.74-4.24 Facebook plus text messages; <i>P</i>=.41) nor calcium-rich food was detected (<i>P</i>=.57). There was a significant improvement in knowledge in the Facebook plus text messages group (<i>P</i>&lt;.001), but habit formation improved less than that in the other 2 groups (<i>P</i>=.01). Our results showed a moderate level of engagement with intervention content and positive qualitative feedback from participants. CONCLUSIONS The CAN-DO study delivered via Facebook (with the additional support of text messages) was found to improve knowledge and was acceptable among young adults. However, further research is needed to better understand social media engagement and how to optimize the program for participants to be sufficiently motivated to increase their intake of calcium-rich foods. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ACTRN12620000097943; http://www.anzctr.org.au/ACTRN12620000097943.aspx


Sign in / Sign up

Export Citation Format

Share Document