scholarly journals The Evaluation of home medication review for patients with type 2 diabetes mellitus by community pharmacists: a randomised controlled trial

2021 ◽  
Vol 19 (3) ◽  
pp. 2397
Author(s):  
M. Rozaini Rosli ◽  
Chin F. Neoh ◽  
David B. Wu ◽  
Nazariah W. Hassan ◽  
Mahani Mahmud ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Community Pharmacists ◽  
Anthropometric Data ◽  
Anthropometric Parameters ◽  
Home Medication ◽  
Medication Wastage ◽  
Randomised Controlled ◽  
The Cost

Background: Successful diabetes treatment requires commitment and understanding of disease management by the patients. Objective: This trial aimed to evaluate the programme effectiveness of home medication review by community pharmacists (HMR-CP) in optimising diabetes care and reducing medication wastage. Methods: A randomised controlled trial was conducted on 166 patients with Type 2 Diabetes Mellitus (T2DM) who were randomly assigned to the intervention or control groups. The intervention group received HMR-CP at 0-month, 3-month, and 6-month. The primary outcome was haemoglobin A1c (HbA1c) while clinical outcomes, anthropometric data, and humanistic outcomes were the secondary outcomes. For the intervention group, drug-related problems (DRP) were classified according to the Pharmaceutical Care Network Europe Foundation (PCNE). Medication adherence was determined based on the Pill Counting Adherence Ratio (PCAR). The cost of medication wastage was calculated based on the total missed dose by the T2DM patients multiplied by the cost of medication. General linear model and generalised estimating equations were used to compare data across the different time-points within and between the groups, respectively. Results: No significant difference was observed in the demographic and anthropometric data at baseline between the two groups except for fasting blood glucose (FBG). There was a significant reduction in the HbA1c (-0.91%) and FBG (-1.62mmol/L) over the study period (p<0.05). A similar observation was noted in diastolic blood pressure (DBP) and total cholesterol (TC) but not in high-density lipoprotein (HDL), and anthropometric parameters. Both utility value and Michigan Diabetes Knowledge Test (MDKT) scores increased significantly over time. As for the intervention group, significant changes in PCAR (p<0.001) and the number of DRP (p<0.001) were noted. Conclusions: HMR-CP significantly improved the glycaemic control, QoL, medication adherence, and knowledge of T2DM patients as well as reduced the number of DRP and cost of medication wastage. However, the impact of HMR-CP on certain clinical and anthropometric parameters remains inconclusive and further investigation is warranted. 

scholarly journals Effects of telemonitoring on glycaemic control and healthcare costs in type 2 diabetes: A randomised controlled trial

2017 ◽  
Vol 24 (9) ◽  
pp. 586-595 ◽  
Author(s):  
Robin Warren ◽  
Karen Carlisle ◽  
Gabor Mihala ◽  
Paul A Scuffham
Keyword(s):  
Type 2 Diabetes ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Diabetes Care ◽  
Healthcare Costs ◽  
Controlled Trial ◽  
Intervention Group ◽  
Telehealth Intervention ◽  
Randomised Controlled

Introduction This study examined the effect of a telehealth intervention on the control of type 2 diabetes and subsequent potential cost-savings to the health system. Methods This prospective randomised controlled trial randomised adults with type 2 diabetes to the intervention (diabetes program) or control (usual care) arm. Key eligibility criteria included an HbA1c level of at least 58 mmol/mol (7.5%) without severe or unstable comorbidities. All participants continued their usual healthcare, but participants in the intervention arm received additional diabetes care from a diabetes care coordinator via a home monitor that captured clinical measures. Data collected included biomedical, quality of life measures and healthcare (GP, outpatient and inpatient) costs. The primary outcome was HbA1c collected at baseline and 6 months. Analysis was conducted on a complete case intention-to-treat basis. The healthcare system perspective was taken to calculate the incremental cost per percentage-point reduction in HbA1c. Results Results from 63 participants from each study arm were analysed. HbA1c in the intervention group decreased from a median 68 mmol/mol (8.4%) to 58 mmol/mol (7.5%), and remained unchanged in the control group at median 65 mmol/mol (8.1%) at the 6-month endpoint. The intervention effect on HbA1c change was statistically significant ( p = .004). Total healthcare costs in the intervention group, including the intervention costs, were lower (mean $3781 vs. $4662; p < .001) compared with usual care. Discussion There was a clinically meaningful and statistically significant benefit from the telehealth intervention at a lower cost; thus, telehealth was cost-saving and produced greater health benefits compared with usual care.

scholarly journals Effect of a nutrition education programme on clinical status and dietary behaviours of adults with type 2 diabetes in a resource-limited setting in South Africa: a randomised controlled trial

2015 ◽  
Vol 19 (1) ◽  
pp. 142-155 ◽  
Author(s):  
Jane W Muchiri ◽  
Gerda J Gericke ◽  
Paul Rheeder
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Nutrition Education ◽  
Controlled Trial ◽  
Intervention Group ◽  
Education Programme ◽  
Dietary Behaviours ◽  
Resource Limited ◽  
Randomised Controlled

AbstractObjectiveTo evaluate the effect of a participant-customised nutrition education programme on glycated Hb (HbA1c), blood lipids, blood pressure, BMI and dietary behaviours in patients with type 2 diabetes mellitus.DesignA randomised controlled trial. The control group (n 41) received education materials. The intervention group (n 41) received the same education materials and participated in eight weekly (2–2·5 h) group nutrition education sessions and follow-up sessions. Outcomes were assessed at 6 and 12 months. An intention-to-treat analysis was conducted. ANCOVA compared the groups (adjustments for baseline values, age, sex and clinic).SettingTwo community health centres, Moretele sub-district (North West Province), South Africa.SubjectsAdults (aged 40–70 years) with type 2 diabetes, HbA1c ≥8 %.ResultsDifferences in HbA1c (primary outcome) were −0·64 % (P=0·15) at 6 months and −0·63 % (P=0·16) at 12 months in favour of the intervention group. Starchy-food intake was significantly lower in the intervention group, 9·3 v. 10·8 servings/d (P=0·005) at 6 months and 9·9 v. 11·9 servings/d (P=0·017) at 12 months. Median energy intake was significantly lower in the intervention group at 12 months (5988 v. 6946 kJ/d, P=0·017). No significant group differences in BMI, lipid profile, blood pressure and intakes of macronutrients, vegetables and fruits were observed.ConclusionsNutrition education was not efficacious on HbA1c; however, it improved specific dietary behaviours. Group education and hands-on activities appeared to contribute to the improvement. Optimal goal setting and self-efficacy training/assessment could benefit future nutrition education programmes for people with type 2 diabetes mellitus in resource-limited settings.

scholarly journals Effects of Brain Breaks Video Intervention of Decisional Balance among Malaysians with Type 2 Diabetes Mellitus: A Randomised Controlled Trial

2021 ◽  
Vol 18 (17) ◽  
pp. 8972 ◽  
Author(s):  
Aizuddin Hidrus ◽  
Yee Cheng Kueh ◽  
Bachok Norsa’adah ◽  
Yu-Kai Chang ◽  
Garry Kuan
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Controlled Trial ◽  
Intervention Group ◽  
Decisional Balance ◽  
P Value ◽  
Brain Breaks ◽  
Randomised Controlled

Brain Breaks® are structured physical activity (PA) web-based videos designed to promote an interest in learning and health promotion. The objective of this study was to examine its effects on decision balance (DB) which consists of the perceived benefits (Pros) and perceived barriers (Cons) of exercise in people with type 2 diabetes mellitus (T2DM). A randomised controlled trial was conducted among people with T2DM at Hospital Universiti Sains Malaysia. The intervention group received Brain Breaks videos for a period of four months. The intervention and control groups completed the validated Malay version of DB questionnaire for five times, at pre-intervention, the first month, the second month, the third month, and post-intervention. Multivariate Repeated Measures Analysis of Variance was performed for data analysis. A total of 70 participants were included (male = 39; female = 31) with a mean age of 57.6 years (SD = 8.5). The intervention group showed a significant change in the Pros and Cons factors of DB scores over time. The intervention group showed significantly higher scores for the Pros (p-value < 0.001) and lower scores for the Cons (p-value = 0.008) factors than the control group. In conclusion, the Brain Breaks video is an effective intervention to improve decisional balance in patients with T2DM to help them in deciding on behaviour change to be more physically active.

scholarly journals The InnvaDiab-DE-PLAN study: a randomised controlled trial with a culturally adapted education programme improved the risk profile for type 2 diabetes in Pakistani immigrant women

2012 ◽  
Vol 109 (3) ◽  
pp. 529-538 ◽  
Author(s):  
Victoria Telle-Hjellset ◽  
Marte K. Råberg Kjøllesdal ◽  
Benedikte Bjørge ◽  
Gerd Holmboe-Ottesen ◽  
Margareta Wandel ◽  
...  
Keyword(s):  
Blood Glucose ◽  
Immigrant Women ◽  
Controlled Trial ◽  
Intervention Group ◽  
Education Programme ◽  
Control Group ◽  
Intervention Period ◽  
Culturally Adapted ◽  
Randomised Controlled

The objective of the present study was to explore whether a culturally adapted lifestyle education programme would improve the risk factor profile for type 2 diabetes (T2D) and the metabolic syndrome (MetS) among Pakistani immigrant women in Oslo, Norway. The randomised controlled trial (the InnvaDiab study), lasting 7 ± 1 months, comprised six educational sessions about blood glucose, physical activity and diet. Participants (age 25–62 years) were randomised into either a control (n 97) or an intervention (n 101) group. Primary outcome variables were fasting and 2 h blood glucose, and secondary outcome variables were fasting levels of insulin, C-peptide, lipids, glycated Hb, BMI, waist circumference and blood pressure, measured 1–3 weeks before and after the intervention. During the intervention period, the mean fasting blood glucose decreased by 0·16 (95 % CI − 0·27, − 0·05) mmol/l in the intervention group, and remained unchanged in the control group (difference between the groups, P= 0·022). Glucose concentration 2 h after the oral glucose tolerance test decreased by 0·53 (95 % CI − 0·84, − 0·21) mmol/l in the intervention group, but not significantly more than in the control group. A larger reduction in fasting insulin was observed in the intervention group than in the control group (between-group difference, P= 0·036). Among the individuals who attended four or more of the educational sessions (n 59), we found a more pronounced decrease in serum TAG ( − 0·1 (95 % CI − 0·24, 0·07) mmol/l) and BMI ( − 0·48 (95 % CI − 0·78, − 0·18) kg/m2) compared with the control group. During the intervention period, there was a significant increase in participants having the MetS in the control group (from 41 to 57 %), which was not seen in the intervention group (from 44 to 42 %). Participation in a culturally adapted education programme may improve risk factors for T2D and prevent the development of the MetS in Pakistani immigrant women.

scholarly journals A pragmatic randomised controlled trial referring to a Personalised Self-management SUPport Programme (P-SUP) for persons enrolled in a disease management programme for type 2 diabetes mellitus and/or for coronary heart disease

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Uwe Konerding ◽  
Marcus Redaèlli ◽  
Karolin Ackermann ◽  
Sibel Altin ◽  
Sebastian Appelbaum ◽  
...  
Keyword(s):  
Disease Management ◽  
Controlled Trial ◽  
Intervention Group ◽  
Patient Activation ◽  
Self Management ◽  
Control Group ◽  
Randomised Controlled ◽  
Study Participants ◽  
Pragmatic Randomised Controlled Trial

Abstract Background Type 2 diabetes mellitus (T2DM) and coronary heart disease (CHD) are two chronic diseases that cause a tremendous burden. To reduce this burden, several programmes for optimising the care for these diseases have been developed. In Germany, so-called disease management programmes (DMPs), which combine components of Disease Management and the Chronic Care Model, are applied. These DMPs have proven effective. Nevertheless, there are opportunities for improvement. Current DMPs rarely address self-management of the disease, make no use of peer support, and provide no special assistance for persons with low health literacy and/or low patient activation. The study protocol presented here is for the evaluation of a programme that addresses these possible shortcomings and can be combined with current German DMPs for T2DM and CHD. This programme consists of four components: Meetings of peer support groups Personalised telephone-based health coaching for patients with low literacy and/or low patient activation Personalised patient feedback A browser-based web portal Methods Study participants will be adults enrolled in a DMP for T2DM and/or CHD and living in North Rhine-Westphalia, a state of the Federal Republic of Germany. Study participants will be recruited with the assistance of their general practitioners by the end of June 2021. Evaluation will be performed as a pragmatic randomised controlled trial with one intervention group and one waiting control group. The intervention group will receive the intervention for 18 months. During this time, the waiting control group will continue with usual care and the usual measures of their DMPs. After 18 months, the waiting control group will also receive a shortened intervention. The primary outcome is number of hospital days. In addition, the effects on self-reported health-state, physical activity, nutrition, and eight different psychological variables will be investigated. Differences between values at month 18 and at the beginning will be compared to judge the effectiveness of the intervention. Discussion If the intervention proves effective, it may be included into the DMPs for T2DM and CHD. Trial registration The study was registered in the German Clinical Trials Registry (Deutsches Register Klinischer Studien (DRKS)) in early 2019 under the number 00020592. This registry has been affiliated with the WHO Clinical Trials Network (https://www.drks.de/drks_web/setLocale_EN.do) since 2008. It is based on the WHO template, but contains some additional categories for which information has to be given (https://www.drks.de/drks_web/navigate.do?navigationId=entryfields&messageDE=Beschreibung%20der%20Eingabefelder&messageEN=Description%20of%20entry%20fields ). A release and subsequent number assignment only take place when information for all categories has been given.

scholarly journals Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

2021 ◽  
Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Periodontal Health ◽  
Randomized Controlled ◽  
Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

scholarly journals Scale development and an educational program to reduce the stigma of schizophrenia among community pharmacists: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tomoo Fujii ◽  
Manako Hanya ◽  
Kenta Murotani ◽  
Hiroyuki Kamei
Keyword(s):  
Randomized Controlled Trial ◽  
Factor Analysis ◽  
Social Distance ◽  
Educational Program ◽  
Controlled Trial ◽  
Intervention Group ◽  
Community Pharmacists ◽  
Factor I ◽  
Randomized Controlled ◽  
Factor Ii

Abstract Background Stigma associated with mental disorders is rooted among many pharmacists, and represents a major barrier to patient support in community-based psychiatry. We developed an assessment scale that is specifically designed to assess the level of stigma that pharmacists may have toward schizophrenia, and then examined the effects of reducing stigma with an educational program that focuses on communication with patients diagnosed with schizophrenia (PDS) using the newly developed Stigma Scale towards Schizophrenia for Community Pharmacists (SSCP). Methods SSCP was developed by exploratory factor analysis with promax rotation based on responses from 822 randomly selected community pharmacists. Furthermore, a randomized controlled trial was conducted for 115 community pharmacists to clarify the effects of reducing the stigma of schizophrenia using an educational program for them with a focus on communication with PDS. Participants were individually allocated to two groups: educational lecture group (56; only attending a lecture on schizophrenia) or contact-based intervention group (59; communicating with PDS and attending the lecture). The stigma assessment using SSCP was conducted immediately before and after the educational intervention. Results A total of 4 factors and 27 items were extracted from the exploratory factor analysis to comprise the SSCP. Cronbach’s α of SSCP, social distance at professional pharmacy service (factor I), attitudes towards PDS (factor II), self-disclosure (factor III), and social distance in personal (factor IV) were 0.89, 0.88, 0.76, 0.62, and 0.62, respectively. Educational program-related changes of the median (interquartile range) total SSCP score from baseline were − 9.0 (− 16.0 – − 5.0) in the contact-based intervention group and − 3.0 (− 7.0–1.0) in the educational lecture group, reflecting a significant reduction of stigma levels in the contact-based intervention group. On examining the SSCP subscales, scores for factor I and factor II significantly improved. The educational program was more effective for pharmacists aged 20–39 years or with negligible experience of communicating with PDS at work and/or in private life. Conclusions SSCP and the educational program for community pharmacists that focuses on communication with PDS were useful for assessing and reducing, respectively, the stigma attached by these pharmacists to schizophrenia. Trial registration UMIN Clinical Trials Registry (UMIN000043189, registered on January 30, 2021), Retrospectively registered.

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