scholarly journals Research and Implementation Lessons Learned From a Youth-Targeted Digital Health Randomized Controlled Trial (the ARMADILLO Study)

10.2196/13005 ◽  
2019 ◽  
Vol 7 (8) ◽  
pp. e13005
Author(s):  
Lianne Gonsalves ◽  
Winnie Wangari Njeri ◽  
Megan Schroeder ◽  
Jefferson Mwaisaka ◽  
Peter Gichangi
Keyword(s):  
Randomized Controlled Trial ◽  
Digital Health ◽  
Controlled Trial ◽  
Text Message ◽  
Health Interventions ◽  
World Health ◽  
Intervention Period ◽  
Implementation Challenges ◽  
Randomized Controlled ◽  
Client Side

Background Evidence is lacking on the efficacy of sexual and reproductive health (SRH) communication interventions for youth (aged 15-24 years), especially from low- and middle-income countries. Therefore, the World Health Organization initiated the Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) program, a free, menu-based, on-demand text message (SMS, short message service) platform providing validated SRH content developed in collaboration with young people. A randomized controlled trial (RCT) assessing the effect of the ARMADILLO intervention on SRH-related outcomes was implemented in Kwale County, Kenya. Objective This paper describes the implementation challenges related to the RCT, observed during enrollment and the intervention period, and their implications for digital health researchers and program implementers. Methods This was an open, three-armed RCT. Following completion of a baseline survey, participants were randomized into the ARMADILLO intervention (arm 1), a once-a-week contact SMS text message (arm 2), or usual care (arm 3, no intervention). The intervention period lasted seven weeks, after which participants completed an endline survey. Results Two study team decisions had significant implications for the success of the trial’s enrollment and intervention implementation: a hands-off participant recruitment process and a design flaw in an initial language selection menu. As a result, three weeks after recruitment began, 660 participants had been randomized; however, 107 (53%) participants in arm 1 and 136 (62%) in arm 2 were “stuck” at the language menu. The research team called 231 of these nonengaging participants and successfully reached 136 to learn reasons for nonengagement. Thirty-two phone numbers were found to be either not linked to our participants (a wrong number) or not in their primary possession (a shared phone). Among eligible participants, 30 participants indicated that they had assumed the introductory message was a scam or spam. Twenty-seven participants were confused by some aspect of the system. Eleven were apathetic about engaging. Twenty-four nonengagers experienced some sort of technical issue. All participants eventually started their seven-week study period. Conclusions The ARMADILLO study’s implementation challenges provide several lessons related to both researching and implementing client-side digital health interventions, including (1) have meticulous phone data collection protocols to reduce wrong numbers, (2) train participants on the digital intervention in efficacy assessments, and (3) recognize that client-side digital health interventions have analog discontinuation challenges. Implementation lessons were (1) determine whether an intervention requires phone ownership or phone access, (2) digital health campaigns need to establish a credible presence in a busy digital space, and (3) interest in a service can be sporadic or fleeting. Clinical Trial International Standard Randomized Controlled Trial Number (ISRCTN): 85156148; http://www.isrctn. com/ISRCTN85156148

scholarly journals Research and Implementation Lessons Learned From a Youth-Targeted Digital Health Randomized Controlled Trial (the ARMADILLO Study) (Preprint)

2018 ◽  
Author(s):  
Lianne Gonsalves ◽  
Winnie Wangari Njeri ◽  
Megan Schroeder ◽  
Jefferson Mwaisaka ◽  
Peter Gichangi
Keyword(s):  
Randomized Controlled Trial ◽  
Digital Health ◽  
Controlled Trial ◽  
Text Message ◽  
Health Interventions ◽  
World Health ◽  
Intervention Period ◽  
Implementation Challenges ◽  
Randomized Controlled ◽  
Client Side

BACKGROUND Evidence is lacking on the efficacy of sexual and reproductive health (SRH) communication interventions for youth (aged 15-24 years), especially from low- and middle-income countries. Therefore, the World Health Organization initiated the Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) program, a free, menu-based, on-demand text message (SMS, short message service) platform providing validated SRH content developed in collaboration with young people. A randomized controlled trial (RCT) assessing the effect of the ARMADILLO intervention on SRH-related outcomes was implemented in Kwale County, Kenya. OBJECTIVE This paper describes the implementation challenges related to the RCT, observed during enrollment and the intervention period, and their implications for digital health researchers and program implementers. METHODS This was an open, three-armed RCT. Following completion of a baseline survey, participants were randomized into the ARMADILLO intervention (arm 1), a once-a-week contact SMS text message (arm 2), or usual care (arm 3, no intervention). The intervention period lasted seven weeks, after which participants completed an endline survey. RESULTS Two study team decisions had significant implications for the success of the trial’s enrollment and intervention implementation: a hands-off participant recruitment process and a design flaw in an initial language selection menu. As a result, three weeks after recruitment began, 660 participants had been randomized; however, 107 (53%) participants in arm 1 and 136 (62%) in arm 2 were “stuck” at the language menu. The research team called 231 of these nonengaging participants and successfully reached 136 to learn reasons for nonengagement. Thirty-two phone numbers were found to be either not linked to our participants (a wrong number) or not in their primary possession (a shared phone). Among eligible participants, 30 participants indicated that they had assumed the introductory message was a scam or spam. Twenty-seven participants were confused by some aspect of the system. Eleven were apathetic about engaging. Twenty-four nonengagers experienced some sort of technical issue. All participants eventually started their seven-week study period. CONCLUSIONS The ARMADILLO study’s implementation challenges provide several lessons related to both researching and implementing client-side digital health interventions, including (1) have meticulous phone data collection protocols to reduce wrong numbers, (2) train participants on the digital intervention in efficacy assessments, and (3) recognize that client-side digital health interventions have analog discontinuation challenges. Implementation lessons were (1) determine whether an intervention requires phone ownership or phone access, (2) digital health campaigns need to establish a credible presence in a busy digital space, and (3) interest in a service can be sporadic or fleeting. CLINICAL TRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 85156148; http://www.isrctn. com/ISRCTN85156148

scholarly journals Effect of Mobile Phone Text Message Reminders on the Completion and Timely Receipt of Routine Childhood Vaccinations: Superiority Randomized Controlled Trial in Northwest Ethiopia (Preprint)

2021 ◽  
Author(s):  
Zeleke Abebaw Mekonnen ◽  
Kassahun Alemu Gelaye ◽  
Martin Were ◽  
Binyam Tilahun
Keyword(s):  
Randomized Controlled Trial ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Intervention Group ◽  
Text Message ◽  
Northwest Ethiopia ◽  
Health Interventions ◽  
Care Group ◽  
Randomized Controlled ◽  
Routine Childhood

BACKGROUND Nonattendance at vaccination appointments is a big challenge for health workers as it is difficult to track routine vaccination schedules. In Ethiopia, 3 out of 10 children have incomplete vaccination and the timely receipt of the recommended vaccines is low. Thus, innovative strategies are required to reach the last mile where mobile technology can be effectively utilized to achieve better compliance. Despite this promising technology, little is known about the role of text message–based mobile health interventions in improving the complete and timely receipt of routine childhood vaccinations in Ethiopia. OBJECTIVE This trial aimed to determine the effect of mobile phone text message reminders on the completion and timely receipt of routine childhood vaccinations in northwest Ethiopia. METHODS A two-arm, parallel, superiority randomized controlled trial was conducted in 9 health facilities in northwest Ethiopia. A sample size of 434 mother-infant pairs was considered in this trial. Randomization was applied in selected health facilities during enrollment with a 1:1 allocation ratio by using sealed and opaque envelopes. Participants assigned to the intervention group received mobile phone text message reminders one day before the scheduled vaccination visits. Owing to the nature of the intervention, blinding of participants was not possible. Primary outcomes of full and timely completion of vaccinations were measured objectively at 12 months. A two-sample test of proportion and log-binomial regression analyses were used to compare the outcomes between the study groups. A modified intention-to-treat analysis approach was applied and a one-tailed test was reported, considering the superiority design of the trial. RESULTS A total of 426 participants were included for the analysis. We found that a higher proportion of infants in the intervention group received Penta-3 (204/213, 95.8% vs 185/213, 86.9%, respectively; <i>P</i>&lt;.001), measles (195/213, 91.5% vs 169/213, 79.3%, respectively; <i>P</i>&lt;.001), and full vaccination (176/213, 82.6% vs 151/213, 70.9%, respectively; <i>P</i>=.002; risk ratio 1.17, 95% lower CI 1.07) compared to infants in the usual care group. Similarly, a higher proportion of infants in the intervention group received Penta-3 (181/204, 88.7% vs 128/185, 69.2%, respectively; <i>P</i>&lt;.001), measles (170/195, 87.1% vs 116/169, 68.6%, respectively; <i>P</i>&lt;.001), and all scheduled vaccinations (135/213, 63.3% vs 85/213, 39.9%, respectively; <i>P</i>&lt;.001; risk ratio 1.59, 95% lower CI 1.35) on time compared to infants in the usual care group. Of the automatically sent 852 mobile phone text messages, 764 (89.7%) were delivered successfully to the participants. CONCLUSIONS Mobile phone text message reminders significantly improved complete and timely receipt of all recommended vaccines. Besides, they had a significant effect in improving the timely receipt of specific vaccines. Thus, text message reminders can be used to supplement the routine immunization program in resource-limited settings. Considering different contexts, studies on the implementation challenges of mobile health interventions are recommended. CLINICALTRIAL Pan African Clinical Trial Registry PACTR201901533237287; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5839

scholarly journals Effect of Mobile Phone Text Message Reminders on the Completion and Timely Receipt of Routine Childhood Vaccinations: Superiority Randomized Controlled Trial in Northwest Ethiopia

10.2196/27603 ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. e27603
Author(s):  
Zeleke Abebaw Mekonnen ◽  
Kassahun Alemu Gelaye ◽  
Martin Were ◽  
Binyam Tilahun
Keyword(s):  
Randomized Controlled Trial ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Intervention Group ◽  
Text Message ◽  
Northwest Ethiopia ◽  
Health Interventions ◽  
Care Group ◽  
Randomized Controlled ◽  
Routine Childhood

Background Nonattendance at vaccination appointments is a big challenge for health workers as it is difficult to track routine vaccination schedules. In Ethiopia, 3 out of 10 children have incomplete vaccination and the timely receipt of the recommended vaccines is low. Thus, innovative strategies are required to reach the last mile where mobile technology can be effectively utilized to achieve better compliance. Despite this promising technology, little is known about the role of text message–based mobile health interventions in improving the complete and timely receipt of routine childhood vaccinations in Ethiopia. Objective This trial aimed to determine the effect of mobile phone text message reminders on the completion and timely receipt of routine childhood vaccinations in northwest Ethiopia. Methods A two-arm, parallel, superiority randomized controlled trial was conducted in 9 health facilities in northwest Ethiopia. A sample size of 434 mother-infant pairs was considered in this trial. Randomization was applied in selected health facilities during enrollment with a 1:1 allocation ratio by using sealed and opaque envelopes. Participants assigned to the intervention group received mobile phone text message reminders one day before the scheduled vaccination visits. Owing to the nature of the intervention, blinding of participants was not possible. Primary outcomes of full and timely completion of vaccinations were measured objectively at 12 months. A two-sample test of proportion and log-binomial regression analyses were used to compare the outcomes between the study groups. A modified intention-to-treat analysis approach was applied and a one-tailed test was reported, considering the superiority design of the trial. Results A total of 426 participants were included for the analysis. We found that a higher proportion of infants in the intervention group received Penta-3 (204/213, 95.8% vs 185/213, 86.9%, respectively; P<.001), measles (195/213, 91.5% vs 169/213, 79.3%, respectively; P<.001), and full vaccination (176/213, 82.6% vs 151/213, 70.9%, respectively; P=.002; risk ratio 1.17, 95% lower CI 1.07) compared to infants in the usual care group. Similarly, a higher proportion of infants in the intervention group received Penta-3 (181/204, 88.7% vs 128/185, 69.2%, respectively; P<.001), measles (170/195, 87.1% vs 116/169, 68.6%, respectively; P<.001), and all scheduled vaccinations (135/213, 63.3% vs 85/213, 39.9%, respectively; P<.001; risk ratio 1.59, 95% lower CI 1.35) on time compared to infants in the usual care group. Of the automatically sent 852 mobile phone text messages, 764 (89.7%) were delivered successfully to the participants. Conclusions Mobile phone text message reminders significantly improved complete and timely receipt of all recommended vaccines. Besides, they had a significant effect in improving the timely receipt of specific vaccines. Thus, text message reminders can be used to supplement the routine immunization program in resource-limited settings. Considering different contexts, studies on the implementation challenges of mobile health interventions are recommended. Trial Registration Pan African Clinical Trial Registry PACTR201901533237287; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5839

Efficacy and Impact of an mHealth Intervention to promote Mental Wellness for American Indian and Alaska Native Teens and Young Adults: A Randomized Controlled Trial of the BRAVE Study (Preprint)

2020 ◽  
Author(s):  
Stephanie Craig Rushing ◽  
Allyson Kelley ◽  
Sheana Bull ◽  
David Stephens ◽  
Julia Wrobel ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young Adults ◽  
Alaska Native ◽  
Help Seeking ◽  
Culturally Relevant ◽  
Controlled Trial ◽  
Text Message ◽  
Text Messages ◽  
Randomized Controlled ◽  
Mental Wellness

BACKGROUND Culturally-relevant interventions are needed to help American Indian and Alaska Native (AI/AN) teens and young adults navigate common risky situations involving family and friends, including drug and alcohol misuse, dating violence, and suicidality. We R Native – a multimedia health resource for Native teens and young adults – designed an intervention for Native youth, delivered via text message, that includes role model videos, mental wellness strategies, and links to culturally-relevant resources (hotlines, chat-lines, websites, etc.) and social support. OBJECTIVE This study aims to test the efficacy of BRAVE to improve participant’s physical, mental, and spiritual health, their use of mental wellness strategies, their help-seeking skills, and associated factors, including cultural resilience, identity, and cultural pride. METHODS The randomized controlled trial was carried out by the Northwest Portland Area Indian Health Board and the mHealth Impact Lab. The team recruited 2,334 AI/AN teens and young adults nationwide (15-24 years old) via social media channels and text message and enrolled 1,044 to participate. AI/AN teens and young adults enrolled in the study received either: 8 weeks of BRAVE text messages designed to improve mental health, help-seeking skills, and cultural resilience; or 8 weeks of STEM text messages, designed to elevate and re-affirm Native voices in science, technology, engineering, math and medicine (STEM); and then received the other set of messages. Primary and secondary outcomes were tested using linear mixed-effect models and linear regressions. RESULTS A total of 833 AI/AN teens and young adults were included in the analysis. Individuals in the BRAVE and STEM arms showed significant positive trends over the course of the study for all primary outcomes except cultural identity and help seeking behavior. Mean scores were significantly different for health (P<.001), resilience (P<.001), negative coping (P=.027), positive coping (P<.001), self-efficacy (P=.021), and self-esteem (P<.001). Changes in help-seeking self-efficacy were significant for those exhibiting risky behavior at baseline to exit (P=.01). Those who reported positive coping scores at baseline also reported better health on average, but no difference in risky drug and alcohol use (P<.001). The number of participants that used text messages to help themselves increased from 69% at 3-months (427/618) to 75% at 8-months (381/501) (P<.001). Similarly, the number of participants that used text messages to help a friend or family member increased from 22% at 3-months (138/616) to 55% at 8-months (272/498). CONCLUSIONS This is the first nationwide randomized controlled trial for AI/AN teens and young adults to test the efficacy of an mHealth intervention on mental wellness. The findings suggest that culturally-relevant multimedia, mHealth interventions can improve help-seeking behavior. Lessons learned from this study may help other AI/AN-serving organizations, prevention programs, policymakers, researchers, and educators as they support the next generation of AI/AN change-makers.

scholarly journals Effect of automated messaging on oral hygiene in adolescent orthodontic patients: A randomized controlled trial

2018 ◽  
Vol 89 (2) ◽  
pp. 262-267 ◽  
Author(s):  
Mike C. Ross ◽  
Phillip M. Campbell ◽  
Larry P. Tadlock ◽  
Reginald W. Taylor ◽  
Peter H. Buschang
Keyword(s):  
Randomized Controlled Trial ◽  
Oral Hygiene ◽  
Treatment Time ◽  
Controlled Trial ◽  
Text Message ◽  
Text Messages ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Orthodontic Patients ◽  
Hygiene Compliance

ABSTRACTObjective:To determine whether automated text messages sent daily to adolescent orthodontic patients improves oral hygiene more than weekly reminders.Materials and Methods:A blinded, prospective, randomized controlled trial was designed to evaluate the effects of automated messages on oral hygiene. Subjects were recruited from patients undergoing orthodontic treatment at the Texas A&M University College of Dentistry, Department of Orthodontics. They were being treated with a variety of fixed full appliances in both arches. Subjects were randomly assigned to either a once-a-week text message group or a daily text message group. There were 52 females and 27 males who were 12 to 17 years of age. Oral hygiene was measured at the beginning of the study and again 8.6 ± 0.9 weeks later.Results:The daily reminder group (N = 42) had significantly greater improvements in oral hygiene compliance than the weekly reminder group (N = 37). The daily score decreases were 48%, 21% and 19% for the bleeding index (BI), plaque index (PI), and gingival index (GI), respectively. The weekly score decreases were 27%, 14% and 13% for the BI, PI, and GI. There were no sex differences in hygiene changes during the study. The 42% of patients who completed the survey at the end of the study wanted more frequent messages and reported that messages related to decreasing treatment time were the most effective, while those related to oral hygiene were the least effective.Conclusions:Daily text messages are more effective at improving oral hygiene than weekly text messages.

scholarly journals Effect of a Low-fodmap Diet for the Management of Functional Abdominal Pain Disorders in Children: A Study Protocol for a Randomized Controlled Trial

2020 ◽  
Author(s):  
Agata Stróżyk ◽  
Andrea Horvath ◽  
Jane Muir ◽  
Hania Szajewska
Keyword(s):  
Randomized Controlled Trial ◽  
Abdominal Pain ◽  
Controlled Trial ◽  
Well Being ◽  
World Health ◽  
Reliable Change Index ◽  
Functional Abdominal Pain ◽  
Regular Diet ◽  
Randomized Controlled ◽  
Fodmap Diet

Abstract Background Evidence from studies in adults documents that fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) may be triggers of symptoms in individuals with functional abdominal pain disorders (FAPDs). However, in children, the evidence is very limited. We aim to assess the effects of a low-FODMAP diet compared with a regular diet for the management of children with FAPDs. Methods We will perform a randomized, quadruple-blinded, controlled trial. Seventy-four children aged 8 to 18 years with a FAPD (Irritable Bowel Syndrome or Functional Abdominal Pain-Not Otherwise Specified), diagnosed according to the Rome IV criteria, will be randomly allocated to receive either a low-FODMAP diet or a regular diet for 4 weeks. The primary outcome will be the percentage of the responders, defined as the participants who have at least 30% improvement in abdominal pain intensity on a Visual Analogue Scale (VAS) during the last week of the trial compared with baseline, that is at least equal to the Reliable Change Index (≥ 25 mm change on VAS). Other outcomes will include changes in stool consistency, abdominal pain frequency, total scores on the Gastrointestinal Symptom Rating Scale, KIDSCREEN-10 Index and World Health Organization Five Well-Being Index, child’s school attendance and parents’ work absenteeism, and BMI-for-age z-score. Compliance, tolerability of the low-FODMAP diet, and adverse events also will be evaluated. Each FAPD subtype will be assessed separately.DiscussionThere is a need for high-quality evidence regarding the dietary management of children with FAPDs. This randomized controlled trial (RCT) of rigorous methodological design will help to establish the effectiveness, if any, of a low-FODMAP diet for the management of FAPDs in the pediatric population. The findings of this RCT will assist with the development of guidelines and influence the direction of further research. Trial registration: NCT04528914

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