-
1.
Involving Patients in the Development and Evaluation of an Educational and Training Experiential Intervention (ETEI) to Improve Muscle Invasive Bladder Cancer Treatment Decision-making and Post-operative Self-care: a Mixed Methods Approach.
Mohamed, N, Leung, TM, Shah, QN, Pisipati, S, Berry, DL, Benn, EKT, Lee, CT, Hall, S, Mehrazin, R, Sfakianos, J
Journal of cancer education : the official journal of the American Association for Cancer Education. 2020;(4):808-818
-
-
Free full text
-
Abstract
This study aims to describe the acceptability and feasibility of an educational and training experiential intervention (ETEI) we developed to enhance muscle invasive bladder cancer (MIBC) patients with treatment decision-making and post-operative self-care. Twenty-five patients were randomized to a control group (N = 8) or ETEI group (N = 17). ETEI group participated in a nurse-led session on MIBC education. The control group received diet and nutrition education. Study questionnaires were completed at baseline and at 1-month post-intervention. Our results showed acceptable recruitment (58%) and retention rates (68%). The ETEI group reported increased knowledge (82% vs. 50%), improved decisional support (64% vs. 50%), improved communication (73% vs. 50%), and increased confidence in treatment decisions (73% vs. 50%) compared to the control group. Patients in the control group reported improved diet (50% v. 27%) as well as maintaining a healthy lifestyle (67% vs. 45%) compared to the ETEI group. Patients in the ETEI group reported a significant decrease in cancer worries and increases in self-efficacy beliefs over time compared to the control group. The ETEI was feasible, acceptable, and showed a potential for inducing desired changes in cancer worries and efficacy beliefs.
-
2.
Effectiveness of the nurse-led Activate intervention in patients at risk of cardiovascular disease in primary care: a cluster-randomised controlled trial.
Westland, H, Schuurmans, MJ, Bos-Touwen, ID, de Bruin-van Leersum, MA, Monninkhof, EM, Schröder, CD, de Vette, DA, Trappenburg, JC
European journal of cardiovascular nursing. 2020;(8):721-731
-
-
Free full text
-
Abstract
BACKGROUND To understand better the success of self-management interventions and to enable tailoring of such interventions at specific subgroups of patients, the nurse-led Activate intervention is developed targeting one component of self-management (physical activity) in a heterogeneous subgroup (patients at risk of cardiovascular disease) in Dutch primary care. AIM: The aim of this study was to evaluate the effectiveness of the Activate intervention and identifying which patient-related characteristics modify the effect. METHODS A two-armed cluster-randomised controlled trial was conducted comparing the intervention with care as usual. The intervention consisted of four nurse-led behaviour change consultations within a 3-month period. Data were collected at baseline, 3 months and 6 months. Primary outcome was the daily amount of moderate to vigorous physical activity at 6 months. Secondary outcomes included sedentary behaviour, self-efficacy for physical activity, patient activation for self-management and health status. Prespecified effect modifiers were age, body mass index, level of education, social support, depression, patient provider relationship and baseline physical activity. RESULTS Thirty-one general practices (n = 195 patients) were included (intervention group n = 93; control group n = 102). No significant between-group difference was found for physical activity (mean difference 2.49 minutes; 95% confidence interval -2.1; 7.1; P = 0.28) and secondary outcomes. Patients with low perceived social support (P = 0.01) and patients with a low baseline activity level (P = 0.02) benefitted more from the intervention. CONCLUSION The Activate intervention did not improve patients' physical activity and secondary outcomes in primary care patients at risk of cardiovascular disease. To understand the results, the intervention fidelity and active components for effective self-management require further investigation.Trial registration: ClinicalTrials.gov NCT02725203.
-
3.
Engagement and Weight Loss: Results from the Mobile Health and Diabetes Trial.
Muralidharan, S, Ranjani, H, Mohan Anjana, R, Jena, S, Tandon, N, Gupta, Y, Ambekar, S, Koppikar, V, Jagannathan, N, Allender, S, et al
Diabetes technology & therapeutics. 2019;(9):507-513
Abstract
Background: Prevalence of type 2 diabetes (T2D) is increasing worldwide. Identifying and targeting individuals at high risk, is essential for preventing T2D. Several studies point to mobile health initiatives delivered through personal smart devices being a promising approach to diabetes prevention, through weight loss. The aim of the mobile health and diabetes (mDiab) trial was twofold: to achieve 5% weight loss and to look at the association of weight loss with degree of engagement with the mDiab app. Methods: The mDiab randomized control trial was carried out among smartphone users who are at high risk for T2D mellitus in three cities-Chennai, Bengaluru, and New Delhi in India. The intervention was delivered through a mobile phone application along with weekly coach calls for 12 weeks. While individuals in the intervention group individuals received the app, which enabled tracking their weight, physical activity, and diet along with 12 weekly video lessons on T2D prevention and coach calls, the control group received usual care. Results: The intervention group experienced a significant 1 kg weight loss while the control group lost 0.3 kg (P < 0.05). More individuals in the intervention group (n = 139, 15%) met the 5% weight loss target than in the control group (n = 131, 9%). In the intervention group those who viewed the videos experienced greater weight loss (2.4 kg) than those who only attended coach calls (0.9 kg) (P < 0.01). Conclusions: An mHealth intervention helped to achieve moderate weight loss. Future studies should explore the sustainability of this weight loss.
-
4.
Structured multi-disciplinary psychosocial care for cancer patients and the perceived quality of care from the patient perspective: a cluster-randomized trial.
Singer, S, Danker, H, Meixensberger, J, Briest, S, Dietz, A, Kortmann, RD, Stolzenburg, JU, Kersting, A, Roick, J
Journal of cancer research and clinical oncology. 2019;(11):2845-2854
Abstract
PURPOSE We examined whether multi-disciplinary stepped psychosocial care for cancer patients improves quality of care from the patient perspective. METHODS In a university hospital, wards were randomly allocated to either stepped or standard care. Stepped care comprised screening for distress, consultation between doctor and patient, and the provision of psychosocial services. Quality of care was measured with the Quality of Care from the Patient Perspective questionnaire. The analysis employed mixed-effects multivariate regression, adjusting for age and gender. RESULTS Thirteen wards were randomized, and 1012 patients participated (n = 570 in stepped care and n = 442 in standard care). Patients who were highly distressed at baseline had 2.3 times the odds of saying they had had the possibility to converse in private with doctors and/or psychologists/social workers when they were in stepped care compared to standard care, 1.3 times the odds of reporting having experienced shared decision-making, 1.1 times the odds of experiencing their doctors as empathic and personal, and 0.6 times the odds of experiencing the care at the ward to be patient oriented. There was no evidence for an effect of stepped care on perceived quality of care in patients with moderate or low distress. CONCLUSIONS Stepped care can improve some aspects of perceived quality of care in highly distressed patients. TRIAL REGISTRATION http://www.clinicaltrials.gov . NCT01859429.
-
5.
Dysglycemia among youth with type 1 diabetes and suboptimal glycemic control in the Flexible Lifestyle Empowering Change trial.
Kahkoska, AR, Crandell, J, Driscoll, KA, Kichler, JC, Seid, M, Mayer-Davis, EJ, Maahs, DM
Pediatric diabetes. 2019;(2):180-188
-
-
Free full text
-
Abstract
OBJECTIVE To examine the prevalence and correlates of non-severe hypoglycemia among adolescents with type 1 diabetes and suboptimal glycemic control, an understudied topic in this group. METHODS Seven days of blinded continuous glucose monitor data were analyzed in 233 adolescents at baseline of the Flexible Lifestyle Empowering Change trial (13-16 years, type 1 diabetes duration >1 year, and hemoglobin A1c [HbA1c] 8-13% [64-119 mmol]). Incidence of clinical hypoglycemia (54-69 mg/dL) and clinically serious hypoglycemia (<54 mg/dL) was defined as number of episodes ≥15 minutes. Logistic regression modeling was used to determine the correlates of long duration of hypoglycemia, categorized by median split among those who experienced hypoglycemia. RESULTS The sample was 76.1% non-Hispanic white, 49.8% female, age = 14.9 ± 1.1 years, diabetes duration = 6.4 ± 3.7 years, and HbA1c = 9.6 ± 1.2% (81 ± 13 mmol/mol). Over 7 days, 79.4% of youth experienced ≥1 hypoglycemic episodes of <70 mg/dL, and 55.4% of youth experienced ≥1 hypoglycemic episodes of <54 mg/dL. Among all adolescents, the median duration of clinical hypoglycemia and clinically serious hypoglycemia was 21.9 (range 0-250.2) and 4.3 (range 0-209.7) minutes/day, respectively. Long duration of clinical hypoglycemia (range 1.8-17.4% time overall) and clinically serious hypoglycemia (range 1.2-14.6% time overall) was associated with older age and decreasing HbA1c. Long duration of clinically serious hypoglycemia also was associated with insulin pump use. CONCLUSIONS Almost 80% of adolescents with elevated HbA1c had an episode of clinical hypoglycemia, and >50% had clinically serious hypoglycemia in a week. Increased education alongside access to emerging diabetes technologies may help to prevent hypoglycemia while improving glycemic control.
-
6.
User Engagement and Attrition in an App-Based Physical Activity Intervention: Secondary Analysis of a Randomized Controlled Trial.
Edney, S, Ryan, JC, Olds, T, Monroe, C, Fraysse, F, Vandelanotte, C, Plotnikoff, R, Curtis, R, Maher, C
Journal of medical Internet research. 2019;(11):e14645
Abstract
BACKGROUND The success of a mobile phone app in changing health behavior is thought to be contingent on engagement, commonly operationalized as frequency of use. OBJECTIVE This subgroup analysis of the 2 intervention arms from a 3-group randomized controlled trial aimed to examine user engagement with a 100-day physical activity intervention delivered via an app. Rates of engagement, associations between user characteristics and engagement, and whether engagement was related to intervention efficacy were examined. METHODS Engagement was captured in a real-time log of interactions by users randomized to either a gamified (n=141) or nongamified version of the same app (n=160). Physical activity was assessed via accelerometry and self-report at baseline and 3-month follow-up. Survival analysis was used to assess time to nonuse attrition. Mixed models examined associations between user characteristics and engagement (total app use). Characteristics of super users (top quartile of users) and regular users (lowest 3 quartiles) were compared using t tests and a chi-square analysis. Linear mixed models were used to assess whether being a super user was related to change in physical activity over time. RESULTS Engagement was high. Attrition (30 days of nonuse) occurred in 32% and 39% of the gamified and basic groups, respectively, with no significant between-group differences in time to attrition (P=.17). Users with a body mass index (BMI) in the healthy range had higher total app use (mean 230.5, 95% CI 190.6-270.5; F2=8.67; P<.001), compared with users whose BMI was overweight or obese (mean 170.6, 95% CI 139.5-201.6; mean 132.9, 95% CI 104.8-161.0). Older users had higher total app use (mean 200.4, 95% CI 171.9-228.9; F1=6.385; P=.01) than younger users (mean 155.6, 95% CI 128.5-182.6). Super users were 4.6 years older (t297=3.6; P<.001) and less likely to have a BMI in the obese range (χ22=15.1; P<.001). At the 3-month follow-up, super users were completing 28.2 (95% CI 9.4-46.9) more minutes of objectively measured physical activity than regular users (F1,272=4.76; P=.03). CONCLUSIONS Total app use was high across the 100-day intervention period, and the inclusion of gamified features enhanced engagement. Participants who engaged the most saw significantly greater increases to their objectively measured physical activity over time, supporting the theory that intervention exposure is linked to efficacy. Further research is needed to determine whether these findings are replicated in other app-based interventions, including those experimentally evaluating engagement and those conducted in real-world settings. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12617000113358; https://www.anzctr.org.au/ACTRN12617000113358.aspx.
-
7.
Diet and exercise changes following bone densitometry in the Patient Activation After DXA Result Notification (PAADRN) study.
Roblin, DW, Cram, P, Lou, Y, Edmonds, SW, Hall, SF, Jones, MP, Saag, KG, Wright, NC, Wolinsky, FD, ,
Archives of osteoporosis. 2018;(1):4
-
-
Free full text
-
Abstract
UNLABELLED Calcium and vitamin D intake and exercise are suboptimal among older adults. Following bone densitometry, a letter communicating individualized fracture risk accompanied by an educational brochure improved participants' lifestyle-but no more than existing communication strategies-over 52 weeks. Simple communication strategies are insufficient for achieving optimal levels of bone health behaviors. PURPOSE The Patient Activation After DXA Result Notification (PAADRN) study was designed to evaluate whether a letter with individualized fracture risk and an educational brochure mailed to patients soon after their DXA might improve bone health behaviors (daily calcium intake, vitamin D supplementation, and weekly exercise sessions) compared to slower, less individualized communication characterizing usual care. METHODS Participants ≥ 50 years were recruited, at three sites, following their DXA and randomized with 1:1 allocation to intervention and control (usual care only) groups. Data were collected at enrollment interview and by phone survey at 12 and 52 weeks thereafter. Intention-to-treat analyses were conducted on 7749 of the 20,397 eligible participants who enrolled. Changes in bone health behaviors were compared within and between study groups. Average treatment effects and heterogeneity of treatment effects were estimated with multivariable linear and logistic regression models. RESULTS In unadjusted analyses, calcium intake, vitamin D supplementation, and weekly exercise sessions increased significantly over 52 weeks within both the intervention and control groups (all p < 0.001). In unadjusted analyses and multivariable models, increases in each behavior did not significantly differ between the intervention and control groups. Intervention group participants with a > 20% 10-year fracture risk at enrollment did, however, have a significantly greater increase in calcium intake compared to other study participants (p = 0.031). CONCLUSIONS Bone health behaviors improved, on average, over 52 weeks among all participants following a DXA. Receipt of the PAADRN letter and educational brochure did not directly improve bone health behaviors compared to usual care. TRIAL REGISTRATION The Patient Activation after DXA Result Notification (PAADRN) Study is registered at ClinicalTrials.Gov: NCT01507662, https://clinicaltrials.gov/ct2/show/NCT01507662.
-
8.
Bundled HIV and Hepatitis C Testing in the Emergency Department: A Randomized Controlled Trial.
Cowan, E, Herman, HS, Rahman, S, Zahn, J, Leider, J, Calderon, Y
The western journal of emergency medicine. 2018;(6):1049-1056
Abstract
INTRODUCTION An estimated 25% of the 1.2 million individuals living with human immunodeficiency virus (HIV) in the U.S. are co-infected with hepatitis C (HCV). The Centers for Disease Control and Prevention recommends HCV testing for high-risk groups. Our goal was to measure the impact of bundled HIV and HCV testing vs. HIV testing alone on test acceptance and identification of HCV and HIV. METHODS We conducted a two-armed, randomized controlled trial on a convenience sample of 478 adult patients in the Jacobi Medical Center emergency department from December 2012 to May 2013. Participants were randomized to receive either an offer of bundled HIV/HCV testing or HIV testing alone. We compared the primary outcome, HIV test acceptance, between the two groups. Secondary outcomes included HIV and HCV prevalence, and HCV test acceptance, refusal, risk, and knowledge. RESULTS We found no significant difference in HIV test acceptance between the bundled HCV/HIV (91.8%) and HIV-only (90.6%) groups (p=0.642). There were also no significant differences in test acceptance based on gender, race, or ethnicity. A majority of participants (76.6%) reported at least one HCV risk factor. No participants tested positive for HIV, and one (0.5%) tested positive for HCV. CONCLUSION Integrating bundled, rapid HCV/HIV testing into an established HIV testing program did not significantly impact HIV test acceptance. Future screening efforts for HCV could be integrated into current HIV testing models to target high-risk cohorts.
-
9.
Comparison of audio vs. audio + video for the rating of shared decision making in oncology using the observer OPTION5 instrument: an exploratory analysis.
Gionfriddo, MR, Branda, ME, Fernandez, C, Leppin, A, Yost, KJ, Kimball, B, Spencer-Bonilla, G, Larrea, L, Nowakowski, KE, Montori, VM, et al
BMC health services research. 2018;(1):522
Abstract
BACKGROUND How non-verbal data may influence observer-administered ratings of shared decision making is unknown. Our objective for this exploratory analysis was to determine the effect of mode of data collection (audio+video vs. audio only) on the scoring of the OPTION5 instrument, an observer rated measure of shared decision making. METHODS We analyzed recordings of 15 encounters between cancer patients and clinicians in which a clinical decision was made. Audio+video or audio only recordings of the encounters were randomly assigned to four trained raters, who reviewed them independently. We compared the adjusted mean scores of audio+video and audio only. RESULTS Forty-one unique decisions were identified within the 15 encounters. The mean OPTION5 score for audio+video was 17.5 (95% CI 13.5, 21.6) and for audio only was 21.8 (95% CI 17.2, 26.4) with a mean difference of 4.28 (95% CI = 0.36, 8.21; p = 0.032). CONCLUSION A rigorous and well established measure of shared decision making performs differently when the data source is audio only. Data source may influence rating of observer administered measures of shared decision making. This potential bias needs to be confirmed as video recording to examine communication behaviors becomes more common.
-
10.
Intervention for childhood obesity based on parents only or parents and child compared with follow-up alone.
Yackobovitch-Gavan, M, Wolf Linhard, D, Nagelberg, N, Poraz, I, Shalitin, S, Phillip, M, Meyerovitch, J
Pediatric obesity. 2018;(11):647-655
Abstract
OBJECTIVES The study aims to assess the effects of family-based interventions targeted to parents only or to parents-and-child for the prevention and treatment of childhood obesity. METHOD An open-label randomized study was conducted in 247 children (166 girls, 5-11 years) with body mass index (BMI) in the 85-98th percentile. Participants were allocated to three groups: parents-only (n = 89), parents-and-child (n = 84) and follow-up alone (n = 74). The intervention consisted of 12 once-weekly meetings with a dietician and psychologist. All children were followed for 2 years. Changes in anthropometric, clinical and lifestyle outcomes were assessed. RESULTS The 3-month intervention was completed by 58 (65.2%) in the parents-only, 61 (72.6%) in the parents-child and 49 (66.2%) in the control group (P = .554). BMI-standard deviation score (SDS) decreased from baseline to 3 months in both intervention groups (parents-only: from 1.74 ± 0.31 to 1.66 ± 0.36, P < .001; parents-child, 1.83 ± 0.33 to 1.76 ± 0.36, P = .012), with no significant change in the controls (1.73 ± 0.32 to 1.70 ± 0.31, P = .301). The 2-year follow-up was completed by 45 in each of the intervention groups (50.5% and 53.5%, respectively) and 37 controls (50%) (P = .896). Compared with baseline, only the parents-child group showed a significant decrease in BMI-SDS (1.56 ± 0.46, P = .006). The rate of children who met the criteria for metabolic syndrome tended to drop from 6.0% at baseline (14/232) to 1.5% at 3 months (12/137) (P = .109), with no significant between-group differences in the rate of metabolic syndrome at baseline or at completion of the intervention. CONCLUSIONS An intervention programme that focuses on both parents and children was found to have positive short-term and long-term effects on BMI-SDS.