Effect of a Multicomponent Home-Based Physical Therapy Intervention on Ambulation After Hip Fracture in Older Adults: The CAP Randomized Clinical Trial.

Importance: Disability persists after hip fracture in older persons. Current rehabilitation may not be sufficient to restore ability to walk in the community. Objective: To compare a multicomponent home-based physical therapy intervention (training) with an active control on ability to walk in the community. Design, Setting, and Participants: Parallel, 2-group randomized clinical trial conducted at 3 US clinical centers (Arcadia University, University of Connecticut Health Center, and University of Maryland, Baltimore). Randomization began on September 16, 2013, and ended on June 20, 2017; follow-up ended on October 17, 2017. Patients aged 60 years and older were enrolled after nonpathologic, minimal trauma hip fracture, if they were living in the community and walking without human assistance before the fracture, were assessed within 26 weeks of hospitalization, and were not able to walk during daily activities at the time of enrollment. A total of 210 participants were randomized and reassessed 16 and 40 weeks later. Interventions: The training intervention (active treatment) (n = 105) included aerobic, strength, balance, and functional training. The active control group (n = 105) received transcutaneous electrical nerve stimulation and active range-of-motion exercises. Both groups received 2 to 3 home visits from a physical therapist weekly for 16 weeks; nutritional counseling; and daily vitamin D (2000 IU), calcium (600 mg), and multivitamins. Main Outcomes and Measures: The primary outcome (community ambulation) was defined as walking 300 m or more in 6 minutes at 16 weeks after randomization. The study was designed to test a 1-sided hypothesis of superiority of training compared with active control. Results: Among 210 randomized participants (mean age, 80.8 years; 161 women [76.7%]), 197 (93.8%) completed the trial (187 [89.0%] by completing the 6-minute walk test at 16 weeks and 10 [4.8%] by adjudication of the primary outcome). Among these, 22 of 96 training participants (22.9%) and 18 of 101 active control participants (17.8%) (difference, 5.1% [1-sided 97.5% CI, -∞ to 16.3%]; 1-sided P = .19) became community ambulators. Seventeen training participants (16.2%) and 15 control participants (14.3%) had 1 or more reportable adverse events during the intervention period. The most common reportable adverse events reported were falls (training: 6 [5.7%], control: 4 [3.8%]), femur/hip fracture (2 in each group), pneumonia (training: 2, control: 0), urinary tract infection (training: 2, control: 0), dehydration (training: 0, control: 2), and dyspnea (training: 0, control: 2). Conclusions and Relevance: Among older adults with a hip fracture, a multicomponent home-based physical therapy intervention compared with an active control that included transcutaneous electrical nerve stimulation and active range-of-motion exercises did not result in a statistically significant improvement in the ability to walk 300 m or more in 6 minutes after 16 weeks. Trial Registration: ClinicalTrials.gov Identifier: NCT01783704.

Identification of Community-Dwelling Older Adults With Shoulder Dysfunction: A Pilot Study to Evaluate the Disabilities of the Arm, Shoulder and Hand Survey.

Introduction: The Disabilities of the Arm, Shoulder and Hand (DASH) survey estimates the upper limbs' dysfunction in one score, but limited evidence exists to justify use of DASH to screen older adults for shoulder dysfunction at routine health maintenance primary care visits. We sought (1) to determine if the DASH, American Shoulder and Elbow Surgeons (ASES) and Simple Shoulder Test (SST) surveys are related to one another and (2) to determine the relationship of DASH, ASES and SST scores with 36-Item Short Form (SF-36) subscales, shoulder forward flexion range of motion (FF-ROM) and abduction (ABD-ROM) in older adults. Methods: Prospective pilot study of 23 community-dwelling adult volunteers [mean age (± standard deviation), 69.3 ± 6.7 years; range, 61-84 years, with no rotator cuff repair or joint replacement. Shoulder MRI, ROM testing, DASH, ASES, SST, SF-36, Katz activities of daily living (ADLs), and Lawton-Brody instrumental ADLs (IADLs) were completed at one time point. Descriptive and correlation analyses were performed. Results: Means: DASH, 17.4 ± 19.5; ASES, 81.3 ± 19.7; SST, 71.7 ± 28.5; Katz ADLs, 5.9 ± .3; Lawton-Brody IADLs, 8.0 ± .0; FF-ROM, 140.2° ± 31.5°; and ABD-ROM, 128.3° ± 31.9°. Nearly 48% had supraspinatus tendon tear. Correlation among DASH, ASES, and SST was strong (|rho ≥.88|; P < .001). DASH, ASES, and SST had strong correlation (|rho ≥.71|;P < .001) with shoulder FF-ROM and ABD-ROM. DASH had near equivalent or slightly stronger correlation for all SF-36 subscales relative to ASES and SST. DASH showed strong or moderate correlation (P < .05) to most SF-36 subscales. Conclusion: DASH, ASES and SST strongly correlated with one another. DASH, relative to ASES and SST, has similar correlation to shoulder FF-ROM, ABD-ROM and SF-36 subscales in older adults. Our pilot study suggests that the DASH survey has potential utility to identify occult shoulder dysfunction in community-dwelling older adults who have normal Katz ADLs and Lawton-Brody IADLs if administered during routine health maintenance primary care visits.

An mHealth Diabetes Intervention for Glucose Control: Health Care Utilization Analysis.

BACKGROUND: Type 2 diabetes (T2D) is a major chronic condition requiring management through lifestyle changes and recommended health service visits. Mobile health (mHealth) is a promising tool to encourage self-management, but few studies have investigated the impact of mHealth on health care utilization. OBJECTIVE: The objective of this analysis was to determine the change in 2-year health service utilization and whether utilization explained a 1.9% absolute decrease in glycated hemoglobin (HbA1c) over 1-year in the Mobile Diabetes Intervention Study (MDIS). METHODS: We used commercial claims data from 2006 to 2010 linked to enrolled patients' medical chart data in 26 primary care practices in Maryland, USA. Secondary claims data analyses were available for 56% (92/163) of participants. In the primary MDIS study, physician practices were recruited and randomized to usual care and 1 of 3 increasingly complex interventions. Patients followed physician randomization assignment. The main variables in the analysis included health service utilization by type of service and change in HbA1c. The claims data was aggregated into 12 categories of utilization to assess change in 2-year health service usage, comparing rates of usage pre- and posttrial. We also examined whether utilization explained the 1.9% decrease in HbA1c over 1 year in the MDIS cluster randomized clinical trial. RESULTS: A significant group by time effect was observed in physician office visits, general practitioner visits, other outpatient services, prescription medications, and podiatrist visits. Physician office visits (P=.01) and general practitioner visits (P=.02) both decreased for all intervention groups during the study period, whereas prescription claims (P<.001) increased. The frequency of other outpatient services (P=.001) and podiatrist visits (P=.04) decreased for the control group and least complex intervention group but increased for the 2 most complex intervention groups. No significant effects of utilization were observed to explain the clinically significant change in HbA1c. CONCLUSIONS: Claims data analyses identified patterns of utilization relevant to mHealth interventions. Findings may encourage patients and health providers to discuss the utilization of treatment-recommended services, lab tests, and prescribed medications. TRIAL REGISTRATION: ClinicalTrials.gov NCT01107015; https://clinicaltrials.gov/ct2/show/NCT01107015 (Archived by Webcite at http://www.webcitation.org/72XgTaxIj).

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

BACKGROUND: 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. OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Clinicaltrials.gov NCT01107015; https://clinicaltrials.gov/ct2/show/NCT01107015 (Archived by WebCite at http://www.webcitation.org/6vVgRCLAF).

Mobile Diabetes Intervention for Glycemic Control: Impact on Physician Prescribing.

Of adults with type 2 diabetes, 84% take antihyperglycemic medication. Successful treatment requires active monitoring and medication dose adjustment by health providers. The objective of this study was to determine how a mobile-phone-based coaching system for diabetes management influences physician prescribing behavior. This secondary data analysis is based on a cluster randomized clinical trial that reported patients provided with mobile self-management had reduction in glycated hemoglobin (HbA1c) of 1.9% over 1 year, compared to 0.7% in control patients (P < .001). Participants were primary care patients with type 2 diabetes randomized at physician practice level into a control group (n = 55) and intervention group (n = 62). Main study measures were patients' medication records (medication, dose, frequency, start and end date) abstracted at baseline and study end. Antihyperglycemic medications, including sulfonylureas or thiazolidinediones, and antihypertensive and antilipemic medications were analyzed. A higher percentage of patients in the intervention group had modification and intensification of incretin mimetics during the 1-year study period (9.7% vs 0.0% and 8.1% vs 0.0%, both P = .008). A higher percentage of patients in the intervention group had modification and intensification of metformin (24.2% vs 7.3%, P = .033). The overall difference in physician prescribing of oral antihyperglycemic medications was not statistically significant. Our results suggest mobile diabetes interventions can encourage physicians to modify and intensify antihyperglycemic medications in patients with type 2 diabetes. Differences in physician prescribing behavior were modest, and do not appear to be large enough to explain a 1.2% decrease in HbA1c.

Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control.

OBJECTIVE: To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with standard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: A cluster-randomized clinical trial, the Mobile Diabetes Intervention Study, randomly assigned 26 primary care practices to one of three stepped treatment groups or a control group (usual care). A total of 163 patients were enrolled and included in analysis. The primary outcome was change in glycated hemoglobin levels over a 1-year treatment period. Secondary outcomes were changes in patient-reported diabetes symptoms, diabetes distress, depression, and other clinical (blood pressure) and laboratory (lipid) values. Maximal treatment was a mobile- and web-based self-management patient coaching system and provider decision support. Patients received automated, real-time educational and behavioral messaging in response to individually analyzed blood glucose values, diabetes medications, and lifestyle behaviors communicated by mobile phone. Providers received quarterly reports summarizing patient's glycemic control, diabetes medication management, lifestyle behaviors, and evidence-based treatment options. RESULTS: The mean declines in glycated hemoglobin were 1.9% in the maximal treatment group and 0.7% in the usual care group, a difference of 1.2% (P = 0.001) [corrected] over 12 months. Appreciable differences were not observed between groups for patient-reported diabetes distress, depression, diabetes symptoms, or blood pressure and lipid levels (all P > 0.05). CONCLUSIONS: The combination of behavioral mobile coaching with blood glucose data, lifestyle behaviors, and patient self-management data individually analyzed and presented with evidence-based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year.