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The Impact of a Mobile Diabetes Health Intervention on Diabetes Distress and Depression Among Adults: Secondary Analysis of a Cluster Randomized Controlled Trial.

ABSTRACT: Diabetes is a complex, demanding disease that requires the constant attention of patients. The burden of self-management, including different medication regimens, routine self-care activities, and provider visits, has an impact on patients' emotional well-being. Diabetes distress and depression are two important components of emotional well-being that may negatively affect diabetes outcomes.The aim was to determine the impact of the 1-year Mobile Diabetes Intervention Study cluster randomized clinical trial on emotional well-being measured by diabetes distress and depression among adults with type 2 diabetes (T2D).A total of 163 adults with not-well-managed T2D were enrolled from community primary care practices. Primary care practices were cluster randomized into either a usual care control group or intervention group. Intervention participants were given a mobile phone with coaching software including a Web portal to communicate with providers. A priori established secondary outcomes included distress measured by the Diabetes Distress Scale (DDS), with subscales measuring emotional burden, interpersonal distress, physician-related distress, and regimen-related distress, as well as depression measured by the Patient Health Questionnaire (PHQ-9). Linear mixed models were used to calculate the effect of the intervention on diabetes distress levels over time, both overall and separately by sex, and to determine if the intervention affected distress or depression. The impact of total DDS on changes in HbA1c was also studied.There were no significant treatment group effects for DDS total (baseline: P=.07; differences over time: P=.38) or for depression (P=.06 over time). Significant declines in total DDS were observed over the 12-month intervention period (P=.01). Regimen-related distress significantly decreased for all study participants (P<.001), but no significant change over time was observed for emotional burden (P=.83), interpersonal distress (P=.64), or physician-related distress (P=.73). Women in both the usual care and intervention groups were more likely to have higher overall DDS, emotional burden, physician-related distress, and regimen-related distress, but not interpersonal distress. Women also reported higher baseline depression compared to men (P=.006). Overall, depression decreased over the treatment period (P=.007), but remained unaffected by group assignment (P=.06) or by sex (P=.97). Diabetes distress had no effect on the change in HbA1c (P=.91) over the treatment period.Although we found no definitive overall or sex-specific effect of the intervention on diabetes distress or depression, this study makes an important contribution to the understanding of mobile health interventions and the impact on emotional health. Our study verified previous work that although diabetes distress and depression are highly correlated, these measures are not evaluating the same construct. Design of future mobile technology provides an opportunity to personalize, contextualize, and intervene in the emotional well-being of persons with diabetes.Clinicaltrials.gov NCT01107015; https://clinicaltrials.gov/ct2/show/NCT01107015 (Archived by WebCite at http://www.webcitation.org/6vVgRCLAF).

SUBMITTER: Quinn CC

PROVIDER: S-EPMC5740263 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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The Impact of a Mobile Diabetes Health Intervention on Diabetes Distress and Depression Among Adults: Secondary Analysis of a Cluster Randomized Controlled Trial.

Quinn Charlene C CC Swasey Krystal K KK Crabbe J Christopher F JCF Shardell Michelle D MD Terrin Michael L ML Barr Erik A EA Gruber-Baldini Ann L AL

JMIR mHealth and uHealth 20171207 12

<h4>Background</h4>Diabetes is a complex, demanding disease that requires the constant attention of patients. The burden of self-management, including different medication regimens, routine self-care activities, and provider visits, has an impact on patients' emotional well-being. Diabetes distress and depression are two important components of emotional well-being that may negatively affect diabetes outcomes.<h4>Objective</h4>The aim was to determine the impact of the 1-year Mobile Diabetes Int ...[more]

PMID: 29217502

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Project description:Mobile phones are increasingly used in health systems in developing countries and innovative technical solutions have great potential to overcome barriers of access to reproductive and child health care. However, despite widespread support for the use of mobile health technologies, evidence for its role in health care is sparse.We aimed to evaluate the association between a mobile phone intervention and perinatal mortality in a resource-limited setting.This study was a pragmatic, cluster-randomized, controlled trial with primary health care facilities in Zanzibar as the unit of randomization. At their first antenatal care visit, 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary health care facilities were included in this study and followed until 42 days after delivery. Twenty-four primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text message and voucher component. Secondary outcome measures included stillbirth, perinatal mortality, and death of a child within 42 days after birth as a proxy of neonatal mortality.Within the first 42 days of life, 2482 children were born alive, 54 were stillborn, and 36 died. The overall perinatal mortality rate in the study was 27 per 1000 total births. The rate was lower in the intervention clusters, 19 per 1000 births, than in the control clusters, 36 per 1000 births. The intervention was associated with a significant reduction in perinatal mortality with an odds ratio (OR) of 0.50 (95% CI 0.27-0.93). Other secondary outcomes showed an insignificant reduction in stillbirth (OR 0.65, 95% CI 0.34-1.24) and an insignificant reduction in death within the first 42 days of life (OR 0.79, 95% CI 0.36-1.74).Mobile phone applications may contribute to improved health of the newborn and should be considered by policy makers in resource-limited settings.ClinicalTrials.gov NCT01821222; http://www.clinicaltrials.gov/ct2/show/NCT01821222 (Archived by WebCite at http://www.webcitation.org/6NqxnxYn0).

Project description:BACKGROUND:The role of technology in health care delivery has grown rapidly in the last decade. The potential of mobile telehealth (MTH) to support patient self-management is a key area of research. Providing patients with technological tools that allow for the recording and transmission of health parameters to health care professionals (HCPs) may promote behavior changes that result in improved health outcomes. Although for some conditions the evidence of the effectiveness of MTH is clear, to date the findings on the effects of MTH on diabetes management remain inconsistent. OBJECTIVE:This study aims to evaluate an MTH intervention among insulin-requiring adults with diabetes to establish whether supplementing standard care with MTH results in improved health outcomes-glycated hemoglobin (HbA1c), blood pressure (BP), health-related quality of life (HRQoL), diabetes self-management behaviors, diabetes health care utilization, and diabetes self-efficacy and illness beliefs. An additional objective was to explore the acceptability of MTH and patients' perceptions of, and experience, using it. METHODS:A mixed-method design consisting of a 9-month, two-arm, parallel randomized controlled trial (RCT) was used in combination with exit qualitative interviews. Quantitative data was collected at baseline, 3 months, and 9 months. Additional intervention fidelity data, such as participants' MTH transmissions and contacts with the MTH nurse during the study, were also recorded. RESULTS:Data collection for both the quantitative and qualitative components of this study has ended and data analysis is ongoing. A total of 86 participants were enrolled into the study. Out of 86 participants, 45 (52%) were randomized to the intervention group and 36 (42%) to the control group. Preliminary data on MTH training sessions and MTH usage by intervention participants are presented in this paper. We expect to publish complete study results in 2015. CONCLUSIONS:The range of data collected in this study will allow for a comprehensive evaluation of processes and outcomes. The early results presented suggest that MTH usage decreases over time and that MTH participants would benefit from attending more than one training session. TRIAL REGISTRATION:ClinicalTrials.gov NCT00922376; http://clinicaltrials.gov/ct2/show/NCT00922376 (Archived by WebCite at http://www.webcitation.org/6Vu4nhLI6).

Project description:BACKGROUND:Poorer diets and subsequent higher rates of chronic disease among lower-income individuals may be partially attributed to reduced access to fresh fruits and vegetables (F&V) and other healthy foods. Mobile markets are an increasingly popular method for providing access to F&V in underserved communities, but evaluation efforts are limited. The purpose of this study was to determine the impact of Veggie Van (VV), a mobile produce market, on F&V intake in lower-income communities using a group randomized controlled trial. METHODS:VV is a mobile produce market that sells reduced-cost locally grown produce and offers nutrition and cooking education. We recruited 12 sites in lower-income communities in North Carolina (USA) to host VV, randomizing them to receive VV immediately (intervention) or after the 6-month study period (delayed intervention control). Participants at each site completed baseline and follow-up surveys including F&V intake, perceived access to fresh F&V and self-efficacy for purchasing, preparing and eating F&V. We used multiple linear regression to calculate adjusted differences in outcomes while controlling for baseline values, education and clustering within site. RESULTS:Among 142 participants who completed the follow-up, baseline F&V intake was 3.48 cups/day for control and 3.33 for intervention. At follow-up, adjusted change in F&V consumption was 0.95 cups/day greater for intervention participants (p?=?0.005), but was attenuated to 0.51 cups per day (p?=?0.11) after removing extreme values. VV customers increased their F&V consumption by 0.41 cups/day (n?=?30) compared to a 0.25 cups/day decrease for 111 non-customers (p?=?0.04). Intervention participants did not show significant improvements in perceived access to fresh F&V, but increased their self-efficacy for working more F&V into snacks (p?=?0.02), making up a vegetable dish with what they had on hand (p?=?0.03), and cooking vegetables in a way that is appealing to their family (p?=?0.048). CONCLUSIONS:Mobile markets may help improve F&V intake in lower-income communities. TRIAL REGISTRATION:Clinicaltrials.gov ID# NCT03026608 retrospectively registered January 2, 2017.

Project description:BackgroundIn longevity societies, one of the most serious social issues is sarcopenia and/or frailty. Preventing them is important for maintaining independence and quality of life in the older population. This study investigated the effect of a self-monitoring comprehensive geriatric intervention programme (CGIP) on physical function and muscle size in community-dwelling older adults. We compared the effects of a CGIP using weekly class-styled (CS) sessions and a home-based (HB) programme.MethodsThe 526 participants were randomized into one of two groups (CS 251, HB 275) based on their residential districts. We conducted a 12 week CGIP, which consisted of low-load resistance exercise, physical activity increments, oral function improvements, and a nutritional guide. All participants were encouraged to attend two 90 min lectures that included instructions on the CGIP. They were provided with exercise materials (triaxial-accelerometers/pedometers, ankle weights, and elastic bands) and diary logs. The CS group attended 90 min weekly sessions and independently executed the programme on other days, whereas the HB group only received instructions on how to execute the programme. Physical functions, such as knee extension strength (KES), normal and maximum walking speed, the timed up-and-go test, and anterior thigh muscle thickness (MT), were measured and analysed using intention-to-treat analysis before and after the 12 week intervention.ResultsOf the 526 participants identified, 517 (CS 243 age 74.0 ± 5.4 women 57.2%, HB 274 age 74.0 ± 5.6 women 58.8%) were enrolled. Nine (CS 8, HB 1) were excluded from the analysis because they did not participate in the pre-intervention measurements. Both interventions significantly improved KES (CS 18.5%, HB 10.6%), normal walking speed (CS 3.7%, HB 2.8%), and MT (CS 3.2%, HB 3.5%). Greater improvement of KES was observed in the CS group (P = 0.003). Maximum walking speed (CS 4.7%, HB 1.8%; P = 0.001) and timed up-and-go (CS -4.7%, HB -0.2%; P < 0.001) significantly improved in the CS group only.ConclusionsThe intervention was effective in preventing sarcopenia and/or frailty. Most physical functions and MT improved after both interventions. The HB intervention is cost-effective and may help prevent sarcopenia and/or frailty in the large older population.

Dataset Information

The Impact of a Mobile Diabetes Health Intervention on Diabetes Distress and Depression Among Adults: Secondary Analysis of a Cluster Randomized Controlled Trial.

Publications

The Impact of a Mobile Diabetes Health Intervention on Diabetes Distress and Depression Among Adults: Secondary Analysis of a Cluster Randomized Controlled Trial.

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