A Randomized Controlled Trial of a Mobile Health Intervention to Promote Self-Management After Lung Transplantation.
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SUBMITTER: DeVito Dabbs A
PROVIDER: S-EPMC4925283 | biostudies-literature | 2016 Jul
REPOSITORIES: biostudies-literature
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A Randomized Controlled Trial of a Mobile Health Intervention to Promote Self-Management After Lung Transplantation.
DeVito Dabbs A A Song M K MK Myers B A BA Li R R Hawkins R P RP Pilewski J M JM Bermudez C A CA Aubrecht J J Begey A A Connolly M M Alrawashdeh M M Dew M A MA
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons 20160314 7
Lung transplant recipients are encouraged to perform self-management behaviors, including (i) monitoring health indicators, (ii) adhering to their regimen, and (iii) reporting abnormal health indicators to the transplant coordinator, yet performance is suboptimal. When hospital discharge was imminent, this two-group trial randomized 201 recipients to use either the mobile health (mHealth) intervention (n = 99) or usual care (n = 102), to compare efficacy for promoting self-management behaviors ( ...[more]
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Project description:BackgroundDigital interventions provided through smartphones or the internet that are guided by a coach have been proposed as promising solutions to support the self-management of chronic conditions. However, digital intervention for poststroke self-management is limited; we developed the interactive Self-Management Augmented by Rehabilitation Technologies (iSMART) intervention to address this gap.ObjectiveThis study aimed to examine the feasibility and initial effects of the iSMART intervention to improve self-management self-efficacy in people with stroke.MethodsA parallel, 2-arm, nonblinded, randomized controlled trial of 12-week duration was conducted. A total of 24 participants with mild-to-moderate chronic stroke were randomized to receive either the iSMART intervention or a manual of stroke rehabilitation (attention control). iSMART was a coach-guided, technology-supported self-management intervention designed to support people managing chronic conditions and maintaining active participation in daily life after stroke. Feasibility measures included retention and engagement rates in the iSMART group. For both the iSMART intervention and active control groups, we used the Feasibility of Intervention Measure, Acceptability of Intervention Measure, and Intervention Appropriateness Measure to assess the feasibility, acceptability, and appropriateness, respectively. Health measures included the Participation Strategies Self-Efficacy Scale and the Patient-Reported Outcomes Measurement Information System's Self-Efficacy for Managing Chronic Conditions.ResultsThe retention rate was 82% (9/11), and the engagement (SMS text message response) rate was 78% for the iSMART group. Mean scores of the Feasibility of Intervention Measure, Acceptability of Intervention Measure, and Intervention Appropriateness Measure were 4.11 (SD 0.61), 4.44 (SD 0.73), and 4.36 (SD 0.70), respectively, which exceeded our benchmark (4 out of 5), suggesting high feasibility, acceptability, and appropriateness of iSMART. The iSMART group showed moderate-to-large effects in improving self-efficacy in managing emotions (r=0.494), symptoms (r=0.514), daily activities (r=0.593), and treatments and medications (r=0.870), but the control group showed negligible-to-small effects in decreasing self-efficacy in managing emotions (r=0.252), symptoms (r=0.262), daily activities (r=0.136), and treatments and medications (r=0.049). In addition, the iSMART group showed moderate-to-large effects of increasing the use of participation strategies for management in the home (r=0.554), work (r=0.633), community (r=0.673), and communication activities (r=0.476). In contrast, the control group showed small-to-large effects of decreasing the use of participation strategies for management in the home (r=0.567), work (r=0.342, community (r=0.215), and communication activities (r=0.379).ConclusionsOur findings support the idea that iSMART was feasible to improve poststroke self-management self-efficacy. Our results also support using a low-cost solution, such as SMS text messaging, to supplement traditional therapeutic patient education interventions. Further evaluation with a larger sample of participants is still needed.Trial registrationClinicalTrials.gov 202004137; https://clinicaltrials.gov/study/NCT04743037?id=202004137&rank=1.
| S-EPMC10912984 | biostudies-literature
Project description:This study tested a mobile health (mHealth) intervention program entitled WeTest, delivered via the WeChat mobile app, to promote oral HIV self-testing (HIVST) among MSM in Hefei, China. A total of 100 MSM participants enrolled, completed baseline assessment, were randomly assigned to intervention or control, and completed 6-month follow-up surveys. Intervention participants (n = 50) received two oral HIVST kits and access to WeTest, a private WeChat group which provided app-based messages and referrals to health services related to HIV. Control participants (n = 50) received two oral HIVST kits only. All participants received instructions to upload photographic results of their oral HIVST, which were sent to the project counselor via a secure WeChat online portal; immediate contact and referrals were made to any participants who tested HIV-positive. In GEE analyses adjusting for time effects and baseline confounders, intervention participants had significantly higher rates of HIV testing (adjusted rate ratio RR = 1.99, 95% confidence interval (CI) 1.07-3.84) and, in particular, higher rates of testing via oral HIVST (adjusted RR = 2.17, 95% CI 1.08-4.37) compared with the control group. Significant time effects were also found such that all participants, regardless of group allocation, had significantly higher rates of reporting consistent condom use with main partners (adjusted RR = 18.13, 95% CI 5.19-63.31) and with non-main partners (adjusted RR = 5.33, 95% CI 2.35-12.08). Findings from this study provide evidence for the feasibility, acceptability and preliminary effects of this mHealth approach to promoting oral HIVST among MSM in China.
| S-EPMC6733671 | biostudies-literature
Project description:IntroductionApproximately 5-8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, most youth do not have access to psychological intervention. Our prior studies demonstrate that an existing internet-delivered pain self-management program (WebMAP) can reduce barriers to care, is feasible, acceptable, and is effective in reducing pain-related disability in youth with chronic pain. The current trial seeks to: 1) determine the effectiveness of a mobile app version of WebMAP for improving patient pain-related outcomes, and 2) evaluate a novel implementation strategy to maximize the public health impact of the intervention including the determination of adoption, reach, and sustainability of WebMAP in specialty clinics serving children with chronic pain in the United States.MethodsThis hybrid effectiveness-implementation cluster randomized controlled trial employs a stepped wedge design in which the WebMAP mobile intervention is sequentially implemented in 8 specialty pain clinics following a usual care period. This trial aims to enroll a minimum of 120 youth (ages 10-17) who have chronic pain. Outcome analyses will determine effectiveness of treatment on adolescent pain-related outcomes as well as public health impact via reach, adoption, implementation, and maintenance.ConclusionsThis trial examines an innovative approach to evaluate a technology-delivered pain self-management program for youth with chronic pain. Findings are expected to yield a strategic approach for delivering a digital pain management program for youth with chronic pain that can be sustained in clinical settings. Clinical Trial Registration #: NCT03332563.
| S-EPMC7080266 | biostudies-literature
Project description:BackgroundIn a randomized controlled trial, lung transplant recipients (LTRs) using a mobile health intervention, Pocket Personal Assistant for Tracking Health (Pocket PATH), showed better adherence to the medical regimen than LTRs receiving usual care during the first year posttransplant. We examined whether these effects were maintained beyond the end of the trial and evaluated other potential risk factors for long-term nonadherence.MethodsAdherence in 8 areas was evaluated at follow-up in separate LTR and family caregiver (collateral) assessments. Pocket PATH and usual care groups' nonadherence rates were compared; multivariable regression analyses then examined and controlled for other patient characteristics' associations with nonadherence.ResultsOne hundred five LTRs (75% of survivors) were assessed (M = 3.9 years posttransplant, SD = 0.8). Nonadherence rates in the past month were 23%-81% for self-care and lifestyle requirements (diet, exercise, blood pressure monitoring, spirometry), 13%-23% for immunosuppressants and other medications, and 4% for tobacco use, with 31% clinic appointment nonadherence in the past year. In multivariable analysis, the Pocket PATH group showed lower risk of nonadherence to lifestyle requirements (diet/exercise) than the usual care group (P < 0.05). Younger age and factors during the first year posttransplant (acute graft rejection, chronically elevated anxiety, less time rehospitalized, nonadherence at the final randomized controlled trial assessment) were each associated with nonadherence in at least 1 area at follow-up (P < 0.05).ConclusionsPocket PATH did not have sustained impact on most areas of the regimen, although we identified other risk factors for long-term nonadherence. Future work should explore strategies to facilitate sustained effects of mobile health interventions.
| S-EPMC7170004 | biostudies-literature
Project description:BACKGROUND:Patients with type 2 diabetes mellitus (T2DM) struggle with the management of their condition due to difficulty relating lifestyle behaviors with glycemic control. While self-monitoring of blood glucose (SMBG) has proven to be effective for those treated with insulin, it has been shown to be less beneficial for those only treated with oral medications or lifestyle modification. We hypothesized that the effective self-management of non-insulin treated T2DM requires a behavioral intervention that empowers patients with the ability to self-monitor, understand the impact of lifestyle behaviors on glycemic control, and adjust their self-care based on contextualized SMBG data. OBJECTIVE:The primary objective of this randomized controlled trial (RCT) is to determine the impact of bant2, an evidence-based, patient-centered, behavioral mobile app intervention, on the self-management of T2DM. Our second postulation is that automated feedback delivered through the mobile app will be as effective, less resource intensive, and more scalable than interventions involving additional health care provider feedback. METHODS:This study is a 12-month, prospective, multicenter RCT in which 150 participants will be randomly assigned to one of two groups: the control group will receive current standard of care, and the intervention group will receive the mobile phone app system in addition to standard of care. The primary outcome measure is change in glycated hemoglobin A1c from baseline to 12 months. RESULTS:The first patient was enrolled on July 28, 2015, and we anticipate completing this study by September, 2018. CONCLUSIONS:This RCT is one of the first to evaluate an evidence-based mobile app that focuses on facilitating lifestyle behavior change driven by contextualized and structured SMBG. The results of this trial will provide insights regarding the usage of mobile tools and consumer-grade devices for diabetes self-care, the economic model of using incentives to motivate behavior change, and the consumption of test strips when following a rigorously structured approach for SMBG. TRIAL REGISTRATION:ClinicalTrials.gov NCT02370719; https://clinicaltrials.gov/ct2/show/NCT02370719 (Archived at http://www.webcitation.org/6jpyjfVRs).
| S-EPMC5010649 | biostudies-literature
Project description:BackgroundUrinary incontinence (UI) is a highly prevalent health concern commonly observed during and after pregnancy that can substantially impact women's physical and psychological well-being and quality of life. Owing to its numerous advantages, mobile health may be a promising solution; however, it is unclear whether the app-based intervention can effectively improve UI symptoms during and after pregnancy.ObjectiveThis study aimed to evaluate the effectiveness of the Urinary Incontinence for Women (UIW) app-based intervention for UI symptom improvement among pregnant women in China.MethodsSingleton pregnant women without incontinence before pregnancy who were aged ≥18 years and between 24 and 28 weeks of gestation were recruited from a tertiary public hospital in China and were randomly allocated (1:1) to either an experimental group (n=63) or a control group (n=63). The experimental group received the UIW app intervention and oral pelvic floor muscle training (PFMT) instructions, whereas the control group received oral PFMT instructions alone. Neither the participants nor the researchers were blinded to the intervention. The primary outcome was UI severity. The secondary outcomes included quality of life, self-efficacy with PFMT, and knowledge of UI. All data were collected at baseline, 2 months after randomization, and 6 weeks post partum through electronic questionnaires or by checking the electronic medical record system. Data analysis followed the intention-to-treat principle. A linear mixed model was used to examine the intervention effect on primary and secondary outcomes.ResultsParticipants in the experimental and control groups were comparable at baseline. Of the 126 overall participants, 117 (92.9%) and 103 (81.7%) women completed follow-up visits at 2 months after randomization and 6 weeks after delivery, respectively. A statistically significant difference in UI symptom severity was observed between the experimental group and control group (2 months after randomization: mean difference -2.86, 95% CI -4.09 to -1.64, P<.001; 6 weeks post partum: mean difference -2.68, 95% CI -3.87 to -1.49, P<.001). For the secondary outcomes, a statistically significant intervention effect on the quality of life, self-efficacy, and UI knowledge was found at the 2-month follow-up (all P<.05) and 6 weeks post partum (all P<.001).ConclusionsThe app-based UI self-management intervention (UIW) effectively improved UI symptom severity, quality of life, self-efficacy with PFMT, and knowledge of UI during the late pregnancy and early postnatal periods. Larger multicenter studies with a longer postpartum follow-up are required to further extend these findings.Trial registrationChinese Clinical Trial Registry ChiCTR1800016171; http://www.chictr.org.cn/showproj.aspx?proj=27455.International registered report identifier (irrid)RR2-10.2196/22771.
| S-EPMC10337423 | biostudies-literature
Project description:BackgroundThis study examines the effects of the COPD-specific health promoting self-management intervention "Better living with COPD" on different self-management-related domains, self-efficacy, and sense of coherence (SOC).MethodsIn a randomized controlled design, 182 people with COPD were allocated to either an intervention group (offered Better living with COPD in addition to usual care) or a control group (usual care). Self-management-related domains were measured by the Health Education Impact Questionnaire (heiQ) before and after intervention. Self-efficacy was measured by the General Self-Efficacy Scale (GSE) and SOC was measured by the 13-item Sense of Coherence Scale (SOC-13). Effects were assessed by ANCOVA, using intention-to-treat (ITT) analysis and per-protocol analysis (PPA).ResultsThe PPA and the ITT analysis showed significant positive changes on Constructive attitudes and approaches (heiQ) (ITT: P=0.0069; PPA: P=0.0021) and Skill and technique acquisition (heiQ) (ITT: P=0.0405; PPA: P=0.0356). Self-monitoring and insight (heiQ) showed significant positive change in the PPA (P=0.0494). No significant changes were found on the other self-management domains (heiQ), self-efficacy (GSE), or SOC (SOC-13).ConclusionBetter living with COPD had a significant positive short-term effect on some self-management-related domains, and could be an intervention contributing to the support of self-management in people with COPD. However, further work is needed to establish the clinical relevance of the findings and to evaluate the long-term effects.
| S-EPMC6231510 | biostudies-literature
Project description:BackgroundHealth literacy is a critically important skill that helps people become active participants in their health care. Multiple studies in the United States and across the world have documented the association of health literacy with multiple health outcomes. In particular, the elderly and many members of minority groups have been shown to have low levels of health literacy; the same groups are disproportionately affected by chronic illnesses. These twin burdens affect the people most in need of the skills and knowledge required for coping with chronic illnesses. Chronic disease self-management (CDSM) is a logical target for a general health literacy intervention. In an approach that spans across specific diseases, CDSM targets problems and skills needed to cope with issues such as fatigue, pain, stress, depression, sleep disturbance, and treatment adherence. In a previous study, we showed that a computer-delivered tailored information intervention targeting health literacy could improve treatment and adherence and be cost effective, but it is not clear that this same strategy will be effective in persons with low health literacy and multiple chronic conditions.ObjectiveThe purpose of this study is to develop a computer-delivered mobile intervention that will provide individuals with chronic conditions the necessary information to cope with their conditions.MethodsIn this project, we will complete a qualitative study on the status and needs of individuals with more than one chronic condition. Results of this study will be used to develop a mobile tailored information app that will address self-management challenges in the areas of pain, sleep, fatigue, depression, anger, stress, memory problems, and treatment adherence. The impact of the intervention on patient quality of life, patient-provider relationships, health literacy, and patient activation will be assessed. We will also explore the extent to which health literacy mediates important outcomes, such as health-related quality of life and health service utilization.ResultsWe are currently completing the preliminary qualitative and usability studies that will inform the content and design of the intervention. We anticipate that the intervention will be complete in 2017, and the clinical trial of its efficacy will also commence in 2017.ConclusionsResults will provide evidence on the usefulness of a mobile tailored information app for improving health literacy, patient activation, health-related quality of life, and self-reported health in patients with multiple chronic conditions.Trial registrationClinicaltrials.gov NCT02922439; https://clinicaltrials.gov/ct2/show/NCT02922439 (Archived by WebCite at http://www.webcitation.org/6pTiqDAyN).
| S-EPMC5399224 | biostudies-literature
Project description:BACKGROUND:Over 90% of women experience pain during breastfeeding initiation and lack strategies to self-manage breast and nipple pain. Guided by the Individual and Family Self-Management Theory, a breastfeeding self-management (BSM) intervention targeted women's knowledge, beliefs, and social facilitation to manage their breast and nipple pain and achieve their breastfeeding goals. OBJECTIVES:The purpose of this longitudinal pilot randomized control trial (RCT) was to test the preliminary efficacy of the BSM intervention on general and specific pain related to breastfeeding. METHODS:Sixty women intending to breastfeed were approached within 48 hours of delivery to participate in this pilot RCT (30 randomized to the BSM intervention and 30 randomized to the control group). All participants provided baseline data before discharge and pain and breastfeeding measures at 1, 2, and 6 weeks. Participants in the BSM intervention group received educational modules addressing breast and nipple pain and biweekly, text-based nurse coaching and completed a daily breastfeeding journal. RESULTS:Women in the BSM intervention group reported significantly less breast and nipple pain at 1 and 2 weeks using a visual analog scale (p < .014 and p < .006) and at 2 weeks using the Brief Pain Inventory intensity scale (p < .029), but no difference in breastfeeding duration. DISCUSSION:The BSM intervention pilot demonstrates a positive effect on breastfeeding specific and overall generalized pain. Future investigation is needed to identify at-risk women of ongoing breastfeeding pain and develop precision interventions to sustain this beneficial health behavior for mothers and infants.
| S-EPMC6400324 | biostudies-literature
Project description:BackgroundAs the increasing prevalence of type 2 diabetes mellitus has put pressure on health systems to appropriately manage these patients, there have been a growing number of mobile apps designed to improve the self-management of diabetes. One such app, BlueStar, has been shown to significantly reduce hemoglobin A1c (HbA1c) levels in small studies and is the first app in the United States to receive Food and Drug Administration approval as a mobile prescription therapy. However, the impact of the app across real-world population among different clinical sites and health systems remains unclear.ObjectiveThe primary objective of this study was to conduct a pragmatic randomized controlled trial of the BlueStar mobile app to determine if app usage leads to improved HbA1c levels among diverse participants in real-life clinical contexts. We hypothesized that this mobile app would improve self-management and HbA1c levels compared with controls.MethodsThe study consisted of a multicenter pragmatic randomized controlled trial. Overall, 110 participants randomized to the immediate treatment group (ITG) received the intervention for 6 months, and 113 participants randomized to the wait-list control (WLC) group received usual care for the first 3 months and then received the intervention for 3 months. The primary outcome was glucose control measured by HbA1c levels at 3 months. Secondary outcomes assessed intervention impact on patient self-management, experience of care, and self-reported health utilization using validated scales, including the Problem Areas in Diabetes, the Summary of Diabetes Self-Care Activities, and the EuroQol-5D. Intervention usage data were collected directly from the app.ResultsThe results of an analysis of covariance controlling for baseline HbA1c levels did not show evidence of intervention impact on HbA1c levels at 3 months (mean difference [ITG-WLC] -0.42, 95% CI -1.05 to 0.21; P=.19). Similarly, there was no intervention effect on secondary outcomes measuring diabetes self-efficacy, quality of life, and health care utilization behaviors. An exploratory analysis of 57 ITG participants investigating the impact of app usage on HbA1c levels showed that each additional day of app use corresponded with a 0.016-point decrease in participants' 3-month HbA1c levels (95% CI -0.03 to -0.003). App usage varied significantly by site, as participants from 1 site logged in to the app a median of 36 days over 14 weeks (interquartile range [IQR] 10.5-124); those at another site used the app significantly less (median 9; IQR 6-51).ConclusionsThe results showed no difference between intervention and control arms for the primary clinical outcome of glycemic control measured by HbA1c levels. Although there was low usage of the app among participants, results indicate contextual factors, particularly site, had a significant impact on overall usage. Future research into the patient and site-specific factors that increase app utilization are needed.Trial registrationClinicaltrials.gov NCT02813343; https://clinicaltrials.gov/ct2/show/NCT02813343 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02813343).
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