Abstract
Mobile Health Interventions (MHIs) have addressed a range of healthcare challenges and have been evaluated using Randomized Controlled Trials (RCTs) to establish clinical effectiveness. Using PRISMA we conducted a systematic literature review of RCTs for MHIs and identified 70 studies which were analyzed and classified using Nickerson-Varshney-Muntermann (NVM) taxonomy. From the resultant iterations of the taxonomy, we extracted insights from the categorized studies. RCTs cover a wide range of health conditions including chronic diseases, general wellness, unhealthy practices, family planning, end-of-life, and post-transplant care. The MHIs that were utilized by the RCTs were varied as well, although most studies did not find significant differences between MHIs and usual care. The challenges for MHI-based RCTs include the use of technologies, delayed outcomes, patient recruitment, patient retention, and complex regulatory requirements. These variances can lead to a higher rate of Type I/Type II errors. Further considerations are the impact of infrastructure, contextual and cultural factors, and reductions in the technological relevancy of the intervention itself. Finally, due to the delayed effect of most outcomes, RCTs of insufficient duration are unable to measure significant, lasting improvements. Using the insights from seventy identified studies, we developed a classification of existing RCTs along with guidelines for MHI-based RCTs and a research framework for future RCTs. The framework offers opportunities for (a) personalization of MHIs, (b) use of richer technologies, and (c) emerging areas for RCTs.
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Appendices
Appendices
Appendix A. Systematic literature review of 70 articles
# | Article | Intervention Objective | Condition | Findings and Limitation |
|---|---|---|---|---|
1 | [17] | Incentives for being smoking-negative | Smoking cessation | mHealth reinforcement led to longest durations of abstinence |
2 | [74] | Nutritional recommendations for fruits, vegs, and takeout meals | Obesity prevention | Intervention group met nutrition recommendations more frequently |
3 | [75] | Effectiveness of mHealth as a decision support intervention | Neonatal mortality | Intervention arm had increased odds of neonatal death (2.09) due to multiple confounding factors |
4 | [11] | Effectiveness of coaching and mobile health in reducing care-seeking, pain, and disability | Chronic low back pain | 38% reduction in care-seeking for the Intervention group |
5 | [76] | Intervention for clinical outcomes and healthy behaviors | Diabetes patients | Hemoglobin levels decreased in intervention group by 1.05% and 0.6% in control: not significant |
6 | [77] | Intervention for engagement, satisfaction, improvement in clinical symptoms and QoL | Mental illness | Higher participation for treatment (90 to 58) and engagement (56 to 40) and no significant outcome |
7 | [23] | Effectiveness of messaging for suicide prevention | Suicide prevention | Message contact can reconnect individuals with support services |
8 | [78] | Effectiveness of activity trackers and coaching for sustaining fitness & physical activity | cardiac rehabilitation | Mhealth increased moderate high physical activity |
9 | [79] | Effectiveness of activity tracker for weight management | Weight management | Significant in waist circumference, logged food per week and weight loss |
10 | [80] | Mobile games for decreasing alcohol dependence using cognitive simulation | Alcohol dependence | Frontal lobe function (executive decision) increases in the intervention group |
11 | [8] | To study adherence of recipients after trial period | Lung transplant | No sustained impact. Age, graft rejection and chronic anxiety associated with nonadherence |
12 | [81] | Effectiveness of an informational m-health app for child safety | Car seat child safety | Significant improvement in car seat type (1.84) and inspection (1.73) |
13 | [82] | mHealth treatment or tablet cognitive gaming for skills | Wheelchair skills | Safety with skill performance is significant |
14 | [18] | Intervention for ‘risky drinking days’ for alcoholics | Alcohol dependence | Significant outpatient treatment adherence and reduction in risky drinking days by 11% |
15 | [83] | Intervention for self-monitoring of blood pressure | Patients with hypertension | Intervention had more rapid communication between patients and providers |
16 | [84] | Use of mindfulness as an intervention | Mental wellbeing for students | Significant decrease in depression, anxiety, and stress, and improved sleep quality |
17 | [85] | Postpartum contraceptive among women and couples | Postpartum contraceptive | Statistically significant (69.9% vs 57.4%) contraceptive use |
18 | [86] | E-mail and SMS for managing weight | Weight control | Reduced body weight, increased activity and vegetable intake, and decreased beverage intake (not statistically significant due to low engagement) |
19 | [87] | Intervention and counseling for self-management and lifestyle change | Diabetes | Statistical improvement in HbA1c level > = 7.1% |
20 | [88] | Effect of m-health on family planning using testing of consumer’s knowledge | Family planning | Access to m-health significant in testing consumer’s knowledge but cannot lead to behavior change |
21 | [89] | Study of recruitment and the trial follow-up of RCT participants to picture of the dropout predictors | Mental health | Engagement using SMS to integrate support for people with serious mental health problems |
22 | [90] | M-health platform on clinical outcomes, patient and provider satisfaction, and app usage | Diabetes | Significantly improved medication adherence and BG testing |
23 | [91] | Mhealth intervention (ADAPT) for medication adherence | Asthma patients | Positive effect on MA with uncontrolled asthma but no effect on adolescents with asthma |
24 | [92] | Online community intervention for adherence to inhaler | Asthma adherence | No statistically significant improvement in adherence |
25 | [93] | Impact of iMHere (interactive mHealth) on health outcomes | Spinal Cord Injury | Reduction in mood symptoms meeting the threshold for clinical significance |
26 | [21] | A mindfulness intervention for cancer patients and caregivers | QoL for cancer patients | Significant improvement in QoL among patients |
27 | [72] | A smart phone and wireless BP monitor as an intervention | Post stroke care | 32% vs 14% improvement of hypertension controlled in small test group of 28 patients |
28 | [94] | M-health intervention for parents in school-based weight management program | Weight management for children and adolescents | Increased in students’ health knowledge and positive psychological impact |
29 | [13] | Sub-analysis of RCT for Smart Care Services of Obese patients | Obesity | Anthropometric indices and laboratory test results improved |
30 | [95] | Intervention to Promote Retention and Adherence to Preexposure Prophylaxis | HIV risk | 16% more likely to attend study visits and 15% more likely to have tenofovir diphosphate levels consistent with < 4 doses/week |
31 | [96] | Study of two prototypes for dietary recoding utilization | Food intake | No control group, test was on usability of applications rather than on modification of health-related behaviors |
32 | [97] | Comparative efficacy of lifestyle application combined with a supervised rehabilitation program versus the lifestyle application alone | QoL and functional outcomes of breast cancer survivors | Reported clinical improvement on QoL was higher with combined app and rehab (57.5% vs 26.3%, P = 0.008) |
33 | [98] | MHealth intervention for self-management of type 2 diabetes | Diabetes | No statistical difference in HbA1c level but an increase in the self-management skills |
34 | [99] | Efficacy of an mHealth prevention program, TXT2BFiT | Weight management in young adults | Modest weight loss and more vegetables, fewer sugary soft drinks, and fewer energy-dense takeout meals |
35 | [100] | Mhealth intervention for self-monitoring and exercise behaviors as a follow up for diabetes prevention program | Diabetes | Prompts effective in the first half of the year but no changes in the second half of the year |
36 | [101] | Web-based mobile pain coping skills training (mPCST) protocol | HCT patients | Significant improvements in pre-treatment and post-treatment pain, self-efficacy, and in the two-minute walk test. No significant changes in pain severity |
37 | [102] | Mhealth intervention for physical activity promotion | Physical activity | Significant change in daily steps by 2534 |
38 | [103] | Mhealth intervention for improving medication adherence and BP control | Renal Transplant recipient | Proof-of-Concept RCT |
39 | [104] | Feasibility of an intervention for blood pressure (BP) self-monitoring | Hypertension | Significant blood pressure reduction over 3-week period |
40 | [105] | Evaluation of a multi-step enrollment process for an RCT to promote regular HIV testing | HIV risk | The need for pre-determined enrollment decision rules based on available resources |
41 | [6] | Effectiveness of 2 interventions separately and combined to promote infant safe sleep practices | Infant sleep | Nursing quality improvement was not significant for all outcomes |
42 | [106] | Mhealth intervention to improve physical activity in college students | Physical activity | Physical activity was higher in step-count but no significant effects for BMI and body fat |
43 | [14] | MINISTOP intervention to improve fat mass index (FMI) using dietary and physical activities | Weight management | No statistically significant difference |
44 | [15] | Assessment of the weight loss achieved by using SmartCare service based on adherence and participation | Obesity Management | Statistically significant improvement to BMI and weight but lipid profile not statistically different between two groups |
45 | [107] | Moderation and Mediation to study improved eating behaviors of young adults | Eating behavior | Weight changes significant and increased vegetable and decreased sweetened beverage intake accounted for indirect weight change effects |
46 | [108] | CHI using mobile devices for risk patients for BP | Pre-BP in rural India | Increased treatment rate, but no outcome on BP |
47 | [109] | Comparing Exercise vs m-health + exercise group | Exercise | Negative outcome (Intervention group did worse in 12 weeks but the same in 52 weeks) |
48 | [12] | Self-management for physical activity | Neurological disability | Commercial MHA improve physical activity |
49 | [110] | MHI and health counseling (3 groups) | Diabetes | No statistical difference in HbA1c in 3 groups at 4 months |
50 | [111] | Comparison of e-health intervention with a mobile health intervention | Physical Activity | eHealth outperformed mHealth for usability and user appreciation, but limited impact on user health and health behaviors |
51 | [112] | Effectiveness of low-cost m-health intervention (text, reminder, messaging) | Noncommunicable diseases in rural and refugee environment | The intervention reduced symptoms in rural but less in refugee camps |
52 | [113] | Self-monitoring using Pocket PATH for patients | Lung Transplant | Promising and proposed for the long-term |
53 | [73] | Mobile health intervention for wellness | Food, weight, BP, & physical activity | No significant difference with small impact of MHI |
54 | [114] | Use of BodiMojo for healthy lifestyle | Diabetes in Young people | No differences in self-efficacy or A1c (82% believed it helped them achieve health goals) |
55 | [16] | Intervention (Calls, TM, apps, resources) for Wellness | Weight management in young people | Modest weight loss, improved dietary behavior and no change in physical activity |
56 | [115] | Use of a self-management app | GOUT | No difference in self-care |
57 | [116] | Effectiveness of Teen Pocket PATH app for patients and their caregivers | Solid organ transplant | Promise in promoting medication adherence among adolescents and caregivers |
58 | [117] | Effectiveness of “Home but not alone” app | Post-partum app | Improved self-efficacy of parents, social support and parental satisfaction |
59 | [118] | Effectiveness of m-health diet and activity intervention + coaching | Diet and health activity risk | The intervention reduces risk |
60 | [119] | Plan ABC app as an educational intervention | Birth control methods for women | No difference in app and regular health counseling group |
61 | [5] | Clinical efficacy of AsthmaCare app | Asthma in children | 72% reduction in urgent care trips |
62 | [120] | M-health intervention for improving the nutritional value in lunchboxes | Nutritional food in the lunchbox | Significant increase in recommended foods in lunchboxes |
63 | [121] | Effectiveness of a therapeutic intervention | Suicide prevention | Reduces distress and depression, but no reduction in suicide ideation or impulsivity |
64 | [122] | Low cost INTV with or without counseling | Diabetes Management | Only 1 of 8 outcomes (skills and technique acquisition) improved |
65 | [22] | Effectiveness of genetic counseling app | Ovarian Cancer | No increased uptake of genetic counseling but increased knowledge, self-efficacy, and communications with family |
66 | [123] | Effectiveness of an app for managing Diabetes | Diabetes | The frequency of hospitalization & rehospitalization is reduced |
67 | [20] | The role of health diets, physical activity, and GWG guidelines | Gestational weight gain | Same food consumption, but less decrease in physical activities, and less weight gain |
68 | [19] | Sexual minority males (Guy2Guy: Text messaging intervention) | Sexual minority males | Improves HIV testing, increased sexual activity and less risky sex |
69 | [124] | Educational intervention for parents to create smoke free home for newborns | Smoking cessation | Increases smoking cessation |
70 | [125] | Feasibility of WeTest as m-health intervention | HIV Testing | Higher rate of testing and condom use with partners and non-partners |
Appendix B. Taxonomy – mobile health interventions evaluated with an RCT
Iteration 1 | Iteration 2 | Iteration 3 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Article | Duration (Months) | Stages | Arms | Blinding | Participant Design | Number of Participants | Intervention Target | Post RCT Evaluation | Health Condition | |||||||||||||||||||
< 3 | 3—6 | > 6 | 1 | 2 | ≥ 3 | 1 | 2 | 3 | Single Blind | Double Blind | Unblinded or Unspecified | Parallel | Crossover | Not Specified | 0 to 10 | 11 to 25 | 26 to 50 | 50 + | Patient | Professional | Both | None | < 3 Months | 3—6 Months | > 6 Months | Existing Condition | Preventative | |
[17] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[74] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[75] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[11] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[76] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[77] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[23] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[78] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[79] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[80] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[8] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[82] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[18] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[83] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[84] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[85] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[86] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[87] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[88] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[89] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[90] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[91] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[92] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[93] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[21] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[72] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[13] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[94] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[95] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[96] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[97] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[98] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[100] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[102] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[103] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[104] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[105] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[6] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[106] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[81] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[14] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[15] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[99] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[107] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[108] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[109] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[12] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[111] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[113] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[73] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[112] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[114] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[16] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[115] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[116] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[117] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[101] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[118] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[119] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[5] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[123] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[120] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[121] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[110] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[122] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[22] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[20] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[19] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[124] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
[125] | x | x | x | x | x | x | x | x | x | |||||||||||||||||||
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Yang, A., Singh, N. & Varshney, U. Mobile Health Interventions and RCTs: Structured Taxonomy and Research Framework. J Med Syst 46, 66 (2022). https://doi.org/10.1007/s10916-022-01856-6
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DOI: https://doi.org/10.1007/s10916-022-01856-6