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Addressing Diabetes and Poorly Controlled Hypertension: Pragmatic mHealth Self-Management Intervention.

ABSTRACT: BACKGROUND:Patients with diabetes and poorly controlled hypertension are at increased risk for adverse renal and cardiovascular outcomes. Identifying these patients early and addressing modifiable risk factors is central to delaying renal complications such as diabetic kidney disease. Mobile health (mHealth), a relatively inexpensive and easily scalable technology, can facilitate patient-centered care and promote engagement in self-management, particularly for patients of lower socioeconomic status. Thus, mHealth may be a cost-effective way to deliver self-management education and support. OBJECTIVE:This feasibility study aimed to build a population management program by identifying patients with diabetes and poorly controlled hypertension who were at risk for adverse renal outcomes and evaluate a multifactorial intervention to address medication self-management. We recruited patients from a federally qualified health center (FQHC) in an underserved, diverse county in the southeastern United States. METHODS:Patients were identified via electronic health record. Inclusion criteria were age between 18 and 75 years, diagnosis of type 2 diabetes, poorly controlled hypertension over the last 12 months (mean clinic systolic blood pressure [SBP] ?140 mm Hg and/or diastolic blood pressure [DBP] ?90 mm Hg), access to a mobile phone, and ability to receive text messages and emails. The intervention consisted of monthly telephone calls for 6 months by a case manager and weekly, one-way informational text messages. Engagement was defined as the number of phone calls completed during the intervention; individuals who completed 4 or more calls were considered engaged. The primary outcome was change in SBP at the conclusion of the intervention. RESULTS:Of the 141 patients enrolled, 84.0% (118/141) of patients completed 1 or more phone calls and had follow-up SBP measurements for analysis. These patients were on average 56.9 years of age, predominately female (73/118, 61.9%), and nonwhite by self-report (103/118, 87.3%). The proportion of participants with poor baseline SBP control (50/118, 42.4%) did not change significantly at study completion (53/118, 44.9%) (P=.64). Participants who completed 4 or more phone calls (98/118, 83.1%) did not experience a statistically significant decrease in SBP when compared to those who completed fewer calls. CONCLUSION:We did not reduce uncontrolled hypertension even among the more highly engaged. However, 83% of a predominately minority and low-income population completed at least 67% of the multimodal mHealth intervention. Findings suggest that combining an automated electronic health record system to identify at-risk patients with a tailored mHealth protocol can provide education to this population. While this intervention was insufficient to effect behavioral change resulting in better hypertension control, it does suggest that this FQHC population will engage in low-cost population health applications with a potentially promising impact. TRIAL REGISTRATION:ClinicalTrials.gov NCT02418091; https://clinicaltrials.gov/ct2/show/NCT02418091 (Archived by WebCite at http://www.webcitation.org/76RBvacVU).

SUBMITTER: Lewinski AA

PROVIDER: S-EPMC6477575 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Addressing Diabetes and Poorly Controlled Hypertension: Pragmatic mHealth Self-Management Intervention.

Lewinski Allison A AA Patel Uptal D UD Diamantidis Clarissa J CJ Oakes Megan M Baloch Khaula K Crowley Matthew J MJ Wilson Jonathan J Pendergast Jane J Biola Holly H Boulware L Ebony LE Bosworth Hayden B HB

Journal of medical Internet research 20190409 4

<h4>Background</h4>Patients with diabetes and poorly controlled hypertension are at increased risk for adverse renal and cardiovascular outcomes. Identifying these patients early and addressing modifiable risk factors is central to delaying renal complications such as diabetic kidney disease. Mobile health (mHealth), a relatively inexpensive and easily scalable technology, can facilitate patient-centered care and promote engagement in self-management, particularly for patients of lower socioecon ...[more]

PMID: 30964439

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Project description:BACKGROUND:Hypertension and diabetes represent the first and third highest contributors to global disability. While mobile health (mHealth) messaging programs have rapidly increased in low- and middle-income countries (LMIC), adaptations for specific patient health needs is a new approach to manage chronic conditions. OBJECTIVE:The primary aim of this study is to develop and test an mHealth communication intervention using electronic data capture (by tablet) and voice messaging to improve hypertension and diabetes self-management in Cambodia. The secondary aim is to share results with the Cambodian Ministry of Health and development partners to inform health policy and develop strategies for hypertension and diabetes control. METHODS:The study design is a cluster randomized controlled clinical trial randomizing each of 75 Community peer educators (PEs), trained and coordinated by MoPoTsyo Patient Information Center in Phnom Penh, into one of 3 groups of 25 (approximately 60 patients each) to receive either tablet+messages, tablet only, or no intervention (control). The total sample within each group includes 25 clusters and approximately 1500 patients located in 7 Operational Districts in rural regions or urban slums in Cambodia. The interventions (groups 1 and 2) were compared with usual PE monitoring without the tablet or mHealth messaging interventions. Focus groups and informant interviews were conducted to develop messages according to specific themes-medications adherence, laboratory testing, physician visits, obesity, smoking, and general lifestyle issues. Using the data received at monthly PE monitoring meetings, patients will receive specific messages based on their individual health challenges. Following the intervention completion, clinical and process outcomes will be compared with baseline metrics between groups. RESULTS:PEs were randomized in July 2017, and the intervention was implemented in September 2017 through June 2018. Analyses are underway. CONCLUSIONS:This project is unique in its combination of electronic data transfer, which can be accessed immediately, with voice messages most relevant to individual patients' needs. Positive results will indicate the value of using targeted messaging in patient-specific, self-management issues to improve hypertension and diabetes control. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11614.

Project description:BackgroundCardiovascular diseases and diabetes are among the leading causes of premature adult deaths in India. Innovative approaches such as clinical decision support (CDS) software could play a major role in improving the quality of hypertension/diabetes care in primary care settings.ObjectiveTo describe the steps and processes in the development of mWellcare, a complex intervention based on mobile health (mHealth) technology.MethodsThe Medical Research Council framework was used to develop mWellcare in four steps: (1) identify gaps in usual care through literature review and health facility assessments; (2) identify the components of the intervention through discussions and consultations with experts; (3) develop intervention (clinical algorithms and mHealth system); and (4) evaluate acceptability and feasibility through pilot testing in five community health centers.ResultsLack of evidence-based, integrated, and systematic management of chronic conditions were major gaps identified. Experts in information technology, clinical fields, and public health professionals identified intervention components to address these gaps. Thereafter, clinical algorithm contextualized to primary care settings were prepared and the mWellcare intervention was developed. During the 2-month pilot, 631 patients diagnosed with hypertension and/or diabetes were registered, with a follow-up rate of 36.2%. The major barrier was resistance to follow mWellcare recommended patient workflow, and to overcome it, we emphasized onsite training and orientation program to cover all health care team member in each CHC.ConclusionA pilot-tested mWellcare intervention is an mHealth system with important components, i.e. integrated management of chronic conditions, evidence-based CDS, longitudinal health data and automated short-messaging service to reinforce compliance to drug intake and follow-up visit, which will be used by nurses at primary health care settings in India. The effectiveness and cost-effectiveness of the intervention will be tested through a cluster randomized trial (trial registration number NCT02480062).

Project description:Mobile health interventions are increasingly used in health care. The level of acceptability may indicate whether and how such digital solutions will be used.This study aimed to explore associations between the level of acceptability of a mobile diabetes app and initial ability of self-management for patients with type 2 diabetes.Participants with type 2 diabetes were recruited from primary health care settings to a 3-armed randomized controlled trial in the Norwegian study in the RENEWING HEALTH project. At the 1-year follow-up, 75 out of 101 participants from the intervention groups completed an acceptability questionnaire (The Service User Technology Acceptability Questionnaire). In the randomized controlled trial, the 2 intervention groups (n=101 in total) received a mobile phone with a diabetes diary app, and one of the groups received additional health counseling given by telephone calls from a diabetes specialist nurse (n=50). At baseline, we collected clinical variables from medical records, whereas demographic data and self-management (The Health Education Impact Questionnaire) measures were self-reported. Log data from the use of the app by self-monitoring were registered continuously. Associations between initial ability to self-manage at baseline and acceptability of the diabetes diary app after 1 year were analyzed using linear regression.We found statistically significant associations between 5 of the 8 self-management domains and perceived benefit, one of the acceptability factors. However, when adjusting for age, gender, and frequency of use, only 1 domain, skill and technique acquisition, remained independently associated with perceived benefit. Frequency of use of the app was the factor that revealed the strongest association with the acceptability domain perceived benefit.Our findings indicate that persons with diabetes may accept the app, despite its perceived benefit being associated with only one of the 8 domains of their initial level of self-management.ClinicalTrials.gov NCT01315756; https://clinicaltrials.gov/show/NCT01315756 (Archived by WebCite at http://www.webcitation.org/6z46qPhWl).

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).

Project description:ObjectiveThe HOME BP (Home and Online Management and Evaluation of Blood Pressure) trial aimed to test a digital intervention for hypertension management in primary care by combining self-monitoring of blood pressure with guided self-management.DesignUnmasked randomised controlled trial with automated ascertainment of primary endpoint.Setting76 general practices in the United Kingdom.Participants622 people with treated but poorly controlled hypertension (>140/90 mm Hg) and access to the internet.InterventionsParticipants were randomised by using a minimisation algorithm to self-monitoring of blood pressure with a digital intervention (305 participants) or usual care (routine hypertension care, with appointments and drug changes made at the discretion of the general practitioner; 317 participants). The digital intervention provided feedback of blood pressure results to patients and professionals with optional lifestyle advice and motivational support. Target blood pressure for hypertension, diabetes, and people aged 80 or older followed UK national guidelines.Main outcome measuresThe primary outcome was the difference in systolic blood pressure (mean of second and third readings) after one year, adjusted for baseline blood pressure, blood pressure target, age, and practice, with multiple imputation for missing values.ResultsAfter one year, data were available from 552 participants (88.6%) with imputation for the remaining 70 participants (11.4%). Mean blood pressure dropped from 151.7/86.4 to 138.4/80.2 mm Hg in the intervention group and from 151.6/85.3 to 141.8/79.8 mm Hg in the usual care group, giving a mean difference in systolic blood pressure of -3.4 mm Hg (95% confidence interval -6.1 to -0.8 mm Hg) and a mean difference in diastolic blood pressure of -0.5 mm Hg (-1.9 to 0.9 mm Hg). Results were comparable in the complete case analysis and adverse effects were similar between groups. Within trial costs showed an incremental cost effectiveness ratio of £11 ($15, €12; 95% confidence interval £6 to £29) per mm Hg reduction.ConclusionsThe HOME BP digital intervention for the management of hypertension by using self-monitored blood pressure led to better control of systolic blood pressure after one year than usual care, with low incremental costs. Implementation in primary care will require integration into clinical workflows and consideration of people who are digitally excluded.Trial registrationISRCTN13790648.

Project description:BackgroundAfrican American individuals are at a higher risk of premature death from cardiovascular diseases than White American individuals, with disproportionate attributable risk from uncontrolled hypertension. Given their high use among African American individuals, mobile technologies, including smartphones, show promise in increasing reliable health information access. Culturally tailored mobile health (mHealth) interventions may promote hypertension self-management among this population.ObjectiveThis formative study aimed to assess the feasibility of integrating an innovative mHealth intervention into clinical and community settings to improve blood pressure (BP) control among African American patients.MethodsA mixed methods study of African American patients with uncontrolled hypertension was conducted over 2 consecutive phases. In phase 1, patients and clinicians from 2 federally qualified health centers (FQHCs) in the Minneapolis-St Paul, Minnesota area, provided input through focus groups to refine an existing culturally tailored mHealth app (Fostering African-American Improvement in Total Health! [FAITH!] App) for promoting hypertension self-management among African American patients with uncontrolled hypertension (renamed as FAITH! Hypertension App). Phase 2 was a single-arm pre-post intervention pilot study assessing feasibility and patient satisfaction. Patients receiving care at an FQHC participated in a 10-week intervention using the FAITH! Hypertension App synchronized with a wireless BP monitor and community health worker (CHW) support to address social determinants of health-related social needs. The multimedia app consisted of a 10-module educational series focused on hypertension and cardiovascular risk factors with interactive self-assessments, medication and BP self-monitoring, and social networking. Primary outcomes were feasibility (app engagement and satisfaction) and preliminary efficacy (change in BP) at an immediate postintervention assessment.ResultsIn phase 1, thirteen African American patients (n=9, 69% aged ≥50 years and n=10, 77% women) and 16 clinicians (n=11, 69% aged ≥50 years; n=14, 88% women; and n=10, 63% African American) participated in focus groups. Their feedback informed app modifications, including the addition of BP and medication tracking, BP self-care task reminders, and culturally sensitive contexts. In phase 2, sixteen African American patients were enrolled (mean age 52.6, SD 12.3 years; 12/16, 75% women). Overall, 38% (6/16) completed ≥50% of the 10 education modules, and 44% (7/16) completed the postintervention assessment. These patients rated the intervention a 9 (out of 10) on its helpfulness in hypertension self-management. Qualitative data revealed that they viewed the app as user-friendly, engaging, and informative, and CHWs were perceived as providing accountability and support. The mean systolic and diastolic BPs of the 7 patients decreased by 6.5 mm Hg (P=.15) and 2.8 mm Hg (P=.78), respectively, at the immediate postintervention assessment.ConclusionsA culturally tailored mHealth app reinforced by CHW support may improve hypertension self-management among underresourced African American individuals receiving care at FQHCs. A future randomized efficacy trial of this intervention is warranted.Trial registrationClinicalTrials.gov NCT04554147; https://clinicaltrials.gov/ct2/show/NCT04554147.

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Addressing Diabetes and Poorly Controlled Hypertension: Pragmatic mHealth Self-Management Intervention.

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Addressing Diabetes and Poorly Controlled Hypertension: Pragmatic mHealth Self-Management Intervention.

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