scholarly journals The Effect of Financial Incentives on Quality Measures in the Treatment of Diabetes Mellitus: a Randomized Controlled Trial

2021 ◽  
Author(s):  
Rahel Meier ◽  
Corinne Chmiel ◽  
Fabio Valeri ◽  
Leander Muheim ◽  
Oliver Senn ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Financial Incentives ◽  
Controlled Trial ◽  
Intervention Group ◽  
Quality Measures ◽  
Control Group ◽  
Randomized Controlled ◽  
Patients With Diabetes

Abstract Background Financial incentives are often used to improve quality of care in chronic care patients. However, the evidence concerning the effect of financial incentives is still inconclusive. Objective To test the effect of financial incentives on quality measures (QMs) in the treatment of patients with diabetes mellitus in primary care. We incentivized a clinical QM and a process QM to test the effect of financial incentives on different types of QMs and to investigate the spill-over effect on non-incentivized QMs. Design/Participants Parallel cluster randomized controlled trial based on electronic medical records database involving Swiss general practitioners (GPs). Practices were randomly allocated. Intervention All participants received a bimonthly feedback report. The intervention group additionally received potential financial incentives on GP level depending on their performance. Main Measures Between-group differences in proportions of patients fulfilling incentivized QM (process QM of annual HbA1c measurement and clinical QM of blood pressure level below 140/95 mmHg) after 12 months. Key Results Seventy-one GPs (median age 52 years, 72% male) from 43 different practices and subsequently 3838 patients with diabetes mellitus (median age 70 years, 57% male) were included. Proportions of patients with annual HbA1c measurements remained unchanged (intervention group decreased from 79.0 to 78.3%, control group from 81.5 to 81.0%, OR 1.09, 95% CI 0.90–1.32, p = 0.39). Proportions of patients with blood pressure below 140/95 improved from 49.9 to 52.5% in the intervention group and decreased from 51.2 to 49.0% in the control group (OR 1.16, 95% CI 0.99–1.36, p = 0.06). Proportions of non-incentivized process QMs increased significantly in the intervention group. Conclusion GP level financial incentives did not result in more frequent HbA1c measurements or in improved blood pressure control. Interestingly, we could confirm a spill-over effect on non-incentivized process QMs. Yet, the mechanism of spill-over effects of financial incentives is largely unclear. Trial Registration ISRCTN13305645

scholarly journals Effect of Steamed Potato Bread Intake on Glucose, Lipids, and Urinary Na+ and K+: A Randomized Controlled Trial with Adolescents

2020 ◽  
Vol 17 (6) ◽  
pp. 2096
Author(s):  
Haiquan Xu ◽  
Yanzhi Guo ◽  
Shijun Lu ◽  
Yunqian Ma ◽  
Xiuli Wang ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Systolic Blood Pressure ◽  
Total Cholesterol ◽  
Controlled Trial ◽  
Intervention Group ◽  
High Density Lipoproteins ◽  
Control Group ◽  
Randomized Controlled ◽  
Potato Bread

Although potatoes are highly nutritious, many epidemiological studies have connected their consumption with abnormal lipids, diabetes, and hypertension. Steamed potato bread has recently become one of China’s staple foods. A randomized controlled trial was designed to evaluate the effect of steamed potato bread consumption on Chinese adolescents. Four classes from a high school were randomly selected and assigned to the intervention group (two classes) or control group (two classes). The steamed wheat bread (100% raw wheat flour) and potato bread (raw wheat flour to cooked potato flour ratio of 3:7) were provided to the control group and intervention group as staple food once a school day for 8 weeks, respectively. Compared with the control group, the intervention group had significant net changes in systolic blood pressure (4.6 mmHg, p = 0.010), insulin (−4.35 mIU/L, p < 0.001), total cholesterol (−0.13 mmol/L, p = 0.032), and high-density lipoproteins cholesterol (−0.07 mmol/L, p = 0.010). The urinary level of Na+/K+ did not differ between the groups. In conclusion, the intake of steamed potato bread for 8 weeks resulted in positive effects on the total cholesterol and insulin profiles but a negative effect on the systolic blood pressure and high-density lipoproteins cholesterol of adolescents.

scholarly journals Long-Term Effects of Financial Incentives for General Practitioners on Quality Indicators in the Treatment of Patients With Diabetes Mellitus in Primary Care—A Follow-Up Analysis of a Cluster Randomized Parallel Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Rahel Meier ◽  
Corinne Chmiel ◽  
Fabio Valeri ◽  
Leander Muheim ◽  
Oliver Senn ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Medical Records ◽  
Financial Incentives ◽  
Controlled Trial ◽  
Intervention Group ◽  
Routine Data ◽  
Control Group ◽  
Long Term Effects ◽  
Patients With Diabetes

Background: The effect of financial incentives on the quality of primary care is of high interest, and so is its sustainability after financial incentives are withdrawn.Objective: To assess both long-term effects and sustainability of financial incentives for general practitioners (GPs) in the treatment of patients with diabetes mellitus based on quality indicators (QIs) calculated from routine data from electronic medical records.Design/Participants: Randomized controlled trial using routine data from electronic medical records of patients with diabetes mellitus of Swiss GPs.Intervention: During the study period of 24 months, all GPs received bimonthly feedback reports with information on their actual treatment as reflected in QIs. In the intervention group, the reports were combined with financial incentives for quality improvement. The incentive was stopped after 12 months.Measurements: Proportion of patients meeting the process QI of annual HbA1c measurements and the clinical QI of blood pressure levels below 140/85 mmHg.Results: A total of 71 GPs from 43 different practices were included along with 3,854 of their patients with diabetes mellitus. Throughout the study, the proportion of patients with annual HbA1c measurements was stable in the intervention group (78.8–78.9%) and decreased slightly in the control group (81.5–80.2%) [odds ratio (OR): 1.21; 95% CI: 1.04–1.42, p &lt; 0.05]. The proportion of patients achieving blood pressure levels below 140/85 mmHg decreased in the control group (51.2–47.2%) and increased in the intervention group (49.7–51.9%) (OR: 1.18; 95% CI: 1.04–1.35, p &lt; 0.05) where it peaked at 54.9% after 18 months and decreased steadily over the last 6 months.Conclusion: After the withdrawal of financial incentives for the GPs after 12 months, some QIs still improved, indicating that 1 year might be too short to observe the full effect of such interventions. The decrease in QI achievement rates after 18 months suggests that the positive effects of time-limited financial incentives eventually wane.

scholarly journals EVALUASI INTERVENSI MEDIA BOOKLET TERHADAP TINGKAT PENGETAHUAN DAN KEPATUHAN PASIEN DIABETES MELITUS TIPE 2 DI PUSKESMAS BANJARBARU SELATAN

2019 ◽  
Vol 6 (1) ◽  
Author(s):  
Valentina Meta Srikartika ◽  
M. Rasyid Akbar ◽  
Herningtyas Nautika Lingga
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
P Value ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Level Of Knowledge ◽  
Diabetes Melitus

ABSTRAKKeberhasilan pengobatan diabetes melitus tidak hanya dipengaruhi oleh kualitas pelayanan kesehatan, keterampilan petugasnya, sikap, dan pola hidup pasien, tetapi dipengaruhi juga oleh kepatuhan pasien terhadap pengobatannya. Tingkat kepatuhan minum obat pasien diabetes mellitus di Indonesia mayoritas masih berada dibawah 50%. Tujuan dari penelitian ini adalah mengukur pengaruh edukasi melalui media booklet terhadap pengetahuan dan kepatuhan pasien diabetes melitus tipe 2. Jenis penelitian yang digunakan adalah Randomized Controlled Trial (RCT). Populasi yang didapat dari penelitian ini sebanyak 40 orang dengan kelompok kontrol 20 orang dan kelompok intervensi 20 orang. Kelompok kontrol merupakan kelompok yang tidak mendapatkan booklet, sedangkan kelompok intervensi adalah kelompok yang mendapatkan booklet sebagi media edukasi. Pengetahuan dan kepatuhan responden diukur melalui kuesioner yang diberikan sebelum (pretest) dan 2 minggu kemudian (posttest). Rata-rata skor pengetahuan dan kepatuhan pre-test dibandingkan dengan skor post-test dengan menggunakan uji Wilcoxon. Berdasarkan hasil analisis, terjadi perbedaan tingkat pengetahuan dan kepatuhan yang signifikan (p value < 0,001) antara sebelum dan sesudah pemberian booklet pada kelompok intervensi dan tidak ada perbedaan yang signifikan pada tingkat pengetahuan (p value = 0,83) dan kepatuhan (p value = 0,317) pada kelompok kontrol. Oleh karena itu, dapat disimpulkan bahwa media booklet dapat meningkatkan tingkat pengetahuan dan kepatuhan pada pasien diabetes melitus.Kata-kata kunci: Diabetes melitus, pengetahuan, kepatuhan, bookletABSTRACTThe success of a treatment of diabetes mellitus is not only influenced by the quality of health services, the skills of its officers, attitudes, and lifestyle of patients, but it is also influenced by patient adherence to treatment. The level of medication compliance among diabetes patients in Indonesia were still below 50%. The purpose of this study was to measure the effect of education through booklet media on the knowledge and compliance of patients with type 2 diabetes mellitus. The type of research used was Randomized Controlled Trial (RCT). The population obtained from this study were 40 people with a control group of 20 people and an intervention group of 20 people. The control group was the group that did not get the booklet, while the intervention group was the group that received the booklet as an educational medium. Knowledge and compliance of respondents was measured through questionnaires given before (pretest) and 2 weeks later (posttest). The average score of knowledge and adherence between pretest and posttest will be compared using Wilcoxon analysis. Based on the results of data analysis with the Wilcoxon test, there was a significant difference in the level of knowledge and compliance (p value < 0.001) between before and after booklet administration in the intervention group and no significant difference in knowledge level (p value = 0.83) and compliance (p value = 0.317) in the control group. It can be concluded that the booklet media can increase the level of knowledge and compliance in diabetes mellitus patients.Keywords: Diabetes mellitus, knowledge, compliance, booklet

scholarly journals Effectiveness of a Non-pharmacological Intervention to Control Diabetes Mellitus in a Primary Care Setting in Kerala: A Cluster-Randomized Controlled Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Arya Rahul ◽  
Sujatha Chintha ◽  
Thekkumkara Surendran Anish ◽  
Kannamkottapilly Chandrasekharan Prajitha ◽  
Pillaveetil Sathyadas Indu
Keyword(s):  
Diabetes Mellitus ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Glycemic Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Baseline Values ◽  
Cluster Randomized

Background: Despite being the first Indian state with a dedicated Non-Communicable Disease (NCD) program, glycemic control among a large proportion of patients is low in Kerala. This study tries to find evidence for a standardized non-pharmacological strategy delivered through Junior Public Health Nurses (JPHNs) in achieving and maintaining glycemic control among diabetic patients registered with NCD clinics of primary health care settings.Design: A cluster randomized controlled trial was conducted among adult patients with Diabetes Mellitus attending NCD clinics of primary care settings of South Kerala, India. JPHNs of the intervention group received additional module-based training while standard management continued in the control group. Sequence generation was done by random permuted blocks method and a cluster of 12 patients was selected from each of the 11 settings by computer-generated random numbers. Patients were followed up for 6 months with monthly monitoring of Fasting Blood Sugar (FBS), Post-Prandial Blood Sugar (PPBS), blood pressure, Body Mass Index (BMI), and health-related behaviors. Knowledge and skills/practice of JPHNs were also evaluated. Analysis of Covariance was done to study the final outcome adjusting for the baseline values and a model for glycemic control was predicted using multilevel modeling.Results: We analyzed 72 participants in the intervention group and 60 participants in the control group according to the intention-to-treat principle. The intervention was associated with a significant reduction in FBS (p &lt; 0.001) and PPBS (p &lt; 0.001) adjusting for the baseline values. The achievement of glycemic control was 1.5 (95% CI: 1.05–2.3) times better with intervention and they showed a better trend of maintenance of glycemic control (FBS, p = 0.003 and PPBS, p = 0.039). Adjusting for clustering and the baseline values, the intervention showed a significant effect on FBS (B = −3.1, SE = 0.57; p &lt; 0.001) and PPBS (B = −0.81, SE = 0.3; p &lt; 0.001) with time. Drug adherence score (p &lt; 0.001), hours of physical activity (p &lt; 0.001), BMI (p = 0.002), fruit intake (p = 0.004), and green leafy vegetable intake (p = 0.01) were the major predictors of FBS control. The practice/skills score of the JPHNs significantly improved with intervention (p &lt; 0.001) adjusting for baseline values.Conclusion: A well-designed health worker intervention package incorporated into the existing health system can translate into attitude change and skill development in the health workers which can reflect in the improvement of glycemic control among the patients.Trial registration: [URL: http://www.ctri.nic.in], identifier [CTRI/2017/11/010622].

scholarly journals Traffic-light labels and financial incentives to reduce sugar-sweetened beverage purchases by low-income Latino families: a randomized controlled trial

2018 ◽  
Vol 21 (8) ◽  
pp. 1426-1434 ◽  
Author(s):  
Rebecca L Franckle ◽  
Douglas E Levy ◽  
Lorena Macias-Navarro ◽  
Eric B Rimm ◽  
Anne N Thorndike
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Financial Incentives ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Traffic Light ◽  
Sugar Sweetened Beverages ◽  
Randomized Controlled ◽  
Sweetened Beverages

AbstractObjectiveThe objective of the present study was to test the effectiveness of financial incentives and traffic-light labels to reduce purchases of sugar-sweetened beverages in a community supermarket.DesignIn this randomized controlled trial, after a 2-month baseline period (February–March 2014), in-store traffic-light labels were posted to indicate healthy (green), less healthy (yellow) or unhealthy (red) beverages. During the subsequent five months (April–August 2014), participants in the intervention arm were eligible to earn a $US 25 in-store gift card each month they refrained from purchasing red-labelled beverages.SettingUrban supermarket in Chelsea, MA, USA, a low-income Latino community.SubjectsParticipants were customers of this supermarket who had at least one child living at home. A total of 148 customers (n 77 in the intervention group and n 71 in the control group) were included in the final analyses.ResultsOutcomes were monthly in-store purchases tracked using a store loyalty card and self-reported consumption of red-labelled beverages. Compared with control participants, the proportion of intervention participants who purchased any red-labelled beverages decreased by 9 % more per month (P=0·002). More intervention than control participants reduced their consumption of red-labelled beverages (−23 % v. −2 % for consuming ≥1 red beverage/week, P=0·01).ConclusionsOverall, financial incentives paired with in-store traffic-light labels modestly reduced purchase and consumption of sugar-sweetened beverages by customers of a community supermarket.

scholarly journals Effect of the Pregnant+ Smartphone App on the Dietary Behavior of Women With Gestational Diabetes Mellitus: Secondary Analysis of a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Lisa Garnweidner-Holme ◽  
Lena Henriksen ◽  
Liv Elin Torheim ◽  
Mirjam Lukasse
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Dietary Behavior ◽  
Smartphone App ◽  
Control Group ◽  
Food Frequency ◽  
Randomized Controlled

BACKGROUND The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. A healthy diet and stable blood glucose levels during pregnancy can prevent adverse health outcomes for the mother and the newborn child. Mobile health may be a useful supplement to prenatal care, providing women with targeted dietary information concerning GDM. OBJECTIVE We analyzed secondary data from a two-arm, multicentered, nonblinded randomized controlled trial to determine if a smartphone app with targeted dietary information and blood glucose monitoring had an effect on the dietary behavior of women with GDM. METHODS Women with a 2-hour oral glucose tolerance test level of ≥9 mmol/L were individually randomized to either the intervention group receiving the Pregnant+ app and usual care or the control group receiving usual care only. Eligible women were enrolled from 5 diabetes outpatient clinics in the Oslo region, Norway, between October 2015 and April 2017. The Pregnant+ app promoted 10 GDM-specific dietary recommendations. A healthy dietary score for Pregnant+ (HDS-P+) was constructed from a 41-item food frequency questionnaire and used to assess the intervention effect on the dietary behavior completed at trial entry and at around gestation week 36. Dietary changes from baseline to week 36 were examined by a paired sample two-tailed <i>t</i> test. Between-group dietary differences after the intervention were estimated with analysis of covariance, with adjustment for baseline diet. RESULTS A total of 238 women participated: 115 were allocated to the intervention group and 123 to the control group. Of the 238 women, 193 (81.1%) completed the food frequency questionnaire both at baseline and around gestational week 36. All the participants showed improvements in their HDS-P+ from baseline. However, the Pregnant+ app did not have a significant effect on their HDS-P+. The control group reported a higher weekly frequency of choosing fish meals (<i>P</i>=.05). No other significant differences were found between the intervention and control groups. There were no significant demographic baseline differences between the groups, except that more women in the intervention group had a non-Norwegian language as their first language (61 vs 46; <i>P</i>=.02). CONCLUSIONS Our findings do not support the supplementation of face-to-face follow-up of women with GDM with a smartphone app in the presence of high-standard usual care, as the Pregnant+ app did not have a beneficial effect on pregnant women’s diet. CLINICALTRIAL ClinicalTrials.gov NCT02588729; https://clinicaltrials.gov/ct2/show/NCT02588729

scholarly journals Fall and Balance Outcomes After an Intervention to Promote Leg Strength, Balance, and Walking in People With Diabetic Peripheral Neuropathy: “Feet First” Randomized Controlled Trial

2010 ◽  
Vol 90 (11) ◽  
pp. 1568-1579 ◽  
Author(s):  
Robin L. Kruse ◽  
Joseph W. LeMaster ◽  
Richard W. Madsen
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Lower Extremity ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Intervention Group ◽  
Control Group ◽  
Foot Care ◽  
Randomized Controlled ◽  
Lower Extremity Strength

Background Weight-bearing exercise has been discouraged for people with diabetes mellitus and peripheral neuropathy (DM+PN). However, people with diabetes mellitus and insensate feet have an increased risk of falling. Lower-extremity exercise and balance training reduce fall risk in some older adults. It is unknown whether those with neuropathy experience similar benefits. Objective As part of a study of the effects of weight-bearing exercise on foot ulceration in people with DM+PN, the effects of a lower-extremity exercise and walking intervention on balance, lower-extremity strength (force-generating capacity), and fall incidence were determined. Design The study was an observer-masked, 12-month randomized controlled trial. Setting Part 1 of the intervention took place in physical therapy offices, and part 2 took place in the community. Patients The participants were 79 people who were mostly sedentary, who had DM+PN, and who were randomly assigned to either a control group (n=38) or an intervention group (n=41). Intervention Part 1 included leg strengthening and balance exercises and a graduated, self-monitored walking program; part 2 included motivational telephone calls. Both groups received regular foot care, foot care education, and 8 sessions with a physical therapist. Measurements The measurements collected were strength, balance, and participant-reported falls for the year after enrollment. Results There were no statistically significant differences between the groups for falls during follow-up. At 12 months, there was a small increase in the amount of time that participants in the intervention group could stand on 1 leg with their eyes closed. No other strength or balance measurements differed between the groups. Limitations The study was designed to detect differences in physical activity, not falls. The intensity of the intervention was insufficient to improve strength and balance in this population. Conclusions The training program had a minimal effect on participants' balance and lower-extremity strength. Increasing weight-bearing activity did not alter the rate of falling for participants in the intervention group relative to that for participants in the control group. People who are sedentary and who have DM+PN appear to be able to increase activity without increasing their rate of falling.

scholarly journals Influence of education training in patients with type 2 diabetes in the improvement of lifestyle and biochemical characteristics: a randomized controlled trial

2019 ◽  
Vol 6 (4) ◽  
pp. 293-299
Author(s):  
Alida Ramaj ◽  
Fatjona Kamberi
Keyword(s):  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
The Mean ◽  
Education Training

Abstract Objective The objective of this randomized controlled trial study was to evaluate the education training in relation to lifestyle improvement in patients with type 2 diabetes through its influence in the levels of glycated hemoglobin (HbA1c), blood pressure, triglyceride, cholesterol levels, and body mass index (BMI). Methods The study included patients with type 2 diabetes randomly selected from 20 residential areas in Tirana, Albania where family physicians provide services. The sample size in total was 200 patients in both groups (control and intervention). The education training (four sessions) was conducted by trained nursing staff for 6 months. Patients were screened for the biochemical profile before and after the intervention. To compare the groups with respect to the interest outcomes, the t-test was used. The value of P < 0.05 was considered significant. Results There were 104 male patients and 96 female patients. The mean age was 54.9 ± 8.7. No significant differences were found between the study groups in relation to clinical and biochemical data before the education sessions. After the intervention, in the intervention group, the mean level of HbA1c was significantly lower than the value in the control group (6.2% vs 6.8%, P = 0.001) as well as for the mean values of BMI. The mean reduction (more than 15%) in HbA1c after the intervention was 43% in the intervention group and 2% in the control group (OR = 36.9, P < 0.05). Differences in BMI, HbA1c, triglycerides, and cholesterol were more significantly visible in the intervention group. However, the difference in systolic and diastolic blood pressure values was almost the same (P > 0.05). Conclusions The results of this study further support that the approach for education of patients with type 2 diabetes on changing lifestyle benefit the patient in controlling diabetes. It is believed that the establishment of diabetes education classes in health centers is an important investment in improving the management of type 2 diabetes.

scholarly journals Effect of the Pregnant+ Smartphone App on the Dietary Behavior of Women With Gestational Diabetes Mellitus: Secondary Analysis of a Randomized Controlled Trial

10.2196/18614 ◽  
2020 ◽  
Vol 8 (11) ◽  
pp. e18614
Author(s):  
Lisa Garnweidner-Holme ◽  
Lena Henriksen ◽  
Liv Elin Torheim ◽  
Mirjam Lukasse
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Dietary Behavior ◽  
Smartphone App ◽  
Control Group ◽  
Food Frequency ◽  
Randomized Controlled

Background The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. A healthy diet and stable blood glucose levels during pregnancy can prevent adverse health outcomes for the mother and the newborn child. Mobile health may be a useful supplement to prenatal care, providing women with targeted dietary information concerning GDM. Objective We analyzed secondary data from a two-arm, multicentered, nonblinded randomized controlled trial to determine if a smartphone app with targeted dietary information and blood glucose monitoring had an effect on the dietary behavior of women with GDM. Methods Women with a 2-hour oral glucose tolerance test level of ≥9 mmol/L were individually randomized to either the intervention group receiving the Pregnant+ app and usual care or the control group receiving usual care only. Eligible women were enrolled from 5 diabetes outpatient clinics in the Oslo region, Norway, between October 2015 and April 2017. The Pregnant+ app promoted 10 GDM-specific dietary recommendations. A healthy dietary score for Pregnant+ (HDS-P+) was constructed from a 41-item food frequency questionnaire and used to assess the intervention effect on the dietary behavior completed at trial entry and at around gestation week 36. Dietary changes from baseline to week 36 were examined by a paired sample two-tailed t test. Between-group dietary differences after the intervention were estimated with analysis of covariance, with adjustment for baseline diet. Results A total of 238 women participated: 115 were allocated to the intervention group and 123 to the control group. Of the 238 women, 193 (81.1%) completed the food frequency questionnaire both at baseline and around gestational week 36. All the participants showed improvements in their HDS-P+ from baseline. However, the Pregnant+ app did not have a significant effect on their HDS-P+. The control group reported a higher weekly frequency of choosing fish meals (P=.05). No other significant differences were found between the intervention and control groups. There were no significant demographic baseline differences between the groups, except that more women in the intervention group had a non-Norwegian language as their first language (61 vs 46; P=.02). Conclusions Our findings do not support the supplementation of face-to-face follow-up of women with GDM with a smartphone app in the presence of high-standard usual care, as the Pregnant+ app did not have a beneficial effect on pregnant women’s diet. Trial Registration ClinicalTrials.gov NCT02588729; https://clinicaltrials.gov/ct2/show/NCT02588729

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

Sign in / Sign up

Export Citation Format

Share Document