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Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients--the INDICA study: a cluster randomized controlled trial.

ABSTRACT: Type 2 diabetes mellitus is a chronic disease whose health outcomes are related to patients and healthcare professionals' decision-making. The Diabetes Intervention study in the Canary Islands (INDICA study) aims to evaluate the effectiveness and cost-effectiveness of educational interventions supported by new technology decision tools for type 2 diabetes patients and primary care professionals in the Canary Islands.The INDICA study is an open, community-based, multicenter, clinical controlled trial with random allocation by clusters to one of three interventions or to usual care. The setting is primary care where physicians and nurses are invited to participate. Patients with diabetes diagnosis, 18-65 years of age, and regular users of mobile phone were randomly selected. Patients with severe comorbidities were excluded. The clusters are primary healthcare practices with enough professionals and available places to provide the intervention. The calculated sample size was 2,300 patients. Patients in group 1 are receiving an educational group program of eight sessions every 3 months led by trained nurses and monitored by means of logs and a web-based platform and tailored semi-automated SMS for continuous support. Primary care professionals in group 2 are receiving a short educational program to update their diabetes knowledge, which includes a decision support tool embedded into the electronic clinical record and a monthly feedback report of patients' results. Group 3 is receiving a combination of the interventions for patients and professionals. The primary endpoint is the change in HbA1c in 2 years. Secondary endpoints are cardiovascular risk factors, macrovascular and microvascular diabetes complications, quality of life, psychological outcomes, diabetes knowledge, and healthcare utilization. Data is being collected from interviews, questionnaires, clinical examinations, and records. Generalized linear mixed models with repeated time measurements will be used to analyze changes in outcomes. The cost-effectiveness analysis, from the healthcare services perspective, involves direct medical costs per quality-adjusted life year gained and two periods, a 'within-trial' period and a lifetime Markov model. Deterministic and probabilistic sensitivity analyses are planned.This ongoing trial aims to set up the implementation of evidence-based programs in the clinical setting for chronic patients.Clinical Trial.gov NCT01657227.

SUBMITTER: Ramallo-Farina Y

PROVIDER: S-EPMC4397722 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients--the INDICA study: a cluster randomized controlled trial.

Ramallo-Fariña Yolanda Y García-Pérez Lidia L Castilla-Rodríguez Iván I Perestelo-Pérez Lilisbeth L Wägner Ana María AM de Pablos-Velasco Pedro P Domínguez Armando Carrillo AC Cortés Mauro Boronat MB Vallejo-Torres Laura L Ramírez Marcos Estupiñán ME Martín Pablo Pedrianes PP García-Puente Ignacio I Salinero-Fort Miguel Ángel MÁ Serrano-Aguilar Pedro Guillermo PG

Implementation science : IS 20150409

<h4>Background</h4>Type 2 diabetes mellitus is a chronic disease whose health outcomes are related to patients and healthcare professionals' decision-making. The Diabetes Intervention study in the Canary Islands (INDICA study) aims to evaluate the effectiveness and cost-effectiveness of educational interventions supported by new technology decision tools for type 2 diabetes patients and primary care professionals in the Canary Islands.<h4>Methods/design</h4>The INDICA study is an open, community ...[more]

PMID: 25880498

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Project description:ObjectiveThis study assesses the effectiveness of different interventions of knowledge transfer and behaviour modification to improve type 2 diabetes mellitus patients' (T2DM) reported outcomes measures (PROMs) in the long-term. Design: open, community-based pragmatic, multicentre, controlled trial with random allocation by clusters to usual care (UC) or to one of the three interventions.ParticipantsA total of 2334 patients with uncomplicated T2DM and 211 healthcare professionals were included of 32 primary care centres.SettingPrimary Care Centers in Canary Islands (Spain).InterventionThe intervention for patients (PTI) included an educational group programme, logs and a web-based platform for monitoring and automated short message service (SMS). The intervention for professionals (PFI) included an educational programme, a decision support tool embedded into the electronic clinical record and periodic feedback about patients' results. A third group received both PTI and PFI (combined intervention, CBI).Outcome measureCognitive-attitudinal, behavioural, affective and health-related quality of life (HQoL) variables.ResultsCompared with UC at 24 months, the PTI group significantly improved knowledge (p=0.005), self-empowerment (p=0.002), adherence to dietary recommendations (p<0.001) and distress (p=0.01). The PFI group improved at 24 months in distress (p=0.03) and at 12 months there were improvements in depression (p=0.003), anxiety (p=0.05), HQoL (p=0.005) and self-empowerment (p<0.001). The CBI group improved at 24 months in self-empowerment (p=0.008) and adherence to dietary recommendations (p=0.004) and at 12 months in knowledge (p=0.008), depression (p=0.006), anxiety (p=0.003), distress (p=0.01), HQoL (p<0.001) and neuropathic symptoms (p=0.02). Statistically significant improvements were also observed at 24 months in the proportion of patients who quit smoking for PTI and CBI (41.5% in PTI and 42.3% in CBI vs 21.2% in the UC group).ConclusionsAssessed interventions to improve PROMs in T2DM attain effectiveness for knowledge, self-empowerment, distress, diet adherence and tobacco cessation. PTI produced the most lasting benefits.Trial registration numberClinicalTrials.gov NCT01657227 (6 August 2012) https://clinicaltrials.gov/ct2/show/NCT01657227.

Project description:BACKGROUND: Insulin analogues may be associated with fewer episodes of hypoglycemia than conventional insulins. However, they are costly alternatives. We compared the cost-effectiveness of insulin analogues and conventional insulins used to treat type 1 and type 2 diabetes mellitus in adults. METHODS: We conducted a cost-effectiveness evaluation of insulin analogues versus conventional insulins using the Center for Outcomes Research Diabetes Model. We compared rapid-acting analogues (insulin aspart and insulin lispro) with regular human insulin, and long-acting analogues (insulin glargine and insulin detemir) with neutral protamine Hagedorn insulin. We derived clinical information for the comparisons from meta-analyses of randomized controlled trials. We obtained cost and utility estimates from published sources. We performed sensitivity analyses to test the robustness of our results. RESULTS: For type 1 diabetes, insulin aspart was more effective and less costly than regular human insulin. Insulin lispro was associated with an incremental cost of Can$28,996 per quality-adjusted life-year. The incremental cost per quality-adjusted life-year was Can$87,932 for insulin glargine and Can$387,729 for insulin detemir, compared with neutral protamine Hagedorn insulin. For type 2 diabetes, insulin aspart was associated with an incremental cost of Can$22,488 per quality-adjusted life-year compared with regular human insulin. For insulin lispro, the incremental cost was Can$130,865. Compared with neutral protamine Hagedorn insulin, insulin detemir was less effective and more costly. Insulin glargine was associated with an incremental cost of Can$642,994 per quality-adjusted life-year. The model was sensitive to changes in the effect size of hemoglobin A(1c) and to decrements applied to utility scores when fear of hypoglycemia was included as a factor. INTERPRETATION: The cost-effectiveness of insulin analogues depends on the type of insulin analogue and whether the patient receiving the treatment has type 1 or type 2 diabetes. With the exception of rapid-acting insulin analogues in type 1 diabetes, routine use of insulin analogues, especially long-acting analogues in type 2 diabetes, is unlikely to represent an efficient use of finite health care resources.

Project description:OBJECTIVES:More than 80% of cardiovascular diseases (CVD) and diabetes mellitus (DM) burden now lies in low and middle-income countries. Hence, there is an urgent need to identify and implement the most cost-effective interventions, particularly in the resource-constraint South Asian settings. Thus, we aimed to systematically review the cost-effectiveness of individual-level, group-level and population-level interventions to control CVD and DM in South Asia. METHODS:We searched 14 electronic databases up to August 2016. The search strategy consisted of terms related to 'economic evaluation', 'CVD', 'DM' and 'South Asia'. Per protocol two reviewers assessed the eligibility and methodological quality of studies using standard checklists, and extracted incremental cost-effectiveness ratios of interventions. RESULTS:Of the 2949 identified studies, 42 met full inclusion criteria. Critical appraisal of studies revealed 15 excellent, 18 good and 9 poor quality studies. Most studies were from India (n=37), followed by Bangladesh (n=3), Pakistan (n=2) and Bhutan (n=1). The economic evaluations were based on observational studies (n=9), randomised trials (n=12) and decision models (n=21). Together, these studies evaluated 301 policy or clinical interventions or combination of both. We found a large number of interventions were cost-effective aimed at primordial prevention (tobacco taxation, salt reduction legislation, food labelling and food advertising regulation), and primary and secondary prevention (multidrug therapy for CVD in high-risk group, lifestyle modification and metformin treatment for diabetes prevention, and screening for diabetes complications every 2-5 years). Significant heterogeneity in analytical framework and outcome measures used in these studies restricted meta-analysis and direct ranking of the interventions by their degree of cost-effectiveness. CONCLUSIONS:The cost-effectiveness evidence for CVD and DM interventions in South Asia is growing, but most evidence is from India and limited to decision modelled outcomes. There is an urgent need for formal health technology assessment and policy evaluations in South Asia using local research data. PROSPERO REGISTRATION NUMBER:CRD42013006479.

Project description:BackgroundChronic diseases, including cardiovascular diseases, diabetes, chronic obstructive pulmonary disease, and cerebrovascular diseases, contribute to the most significant disease burden worldwide, negatively impacting patients and their family members. People with chronic diseases have common modifiable behavioral risk factors, including smoking, alcohol overconsumption, and unhealthy diets. Digital-based interventions for promoting and sustaining behavioral changes have flourished in recent years, although evidence of the cost-effectiveness of such interventions remains inconclusive.ObjectiveIn this study, we aimed to investigate the cost-effectiveness of digital health interventions for behavioral changes among people with chronic diseases.MethodsThis systematic review evaluated published studies focused on the economic evaluation of digital tools for behavioral change among adults with chronic diseases. We followed the Population, Intervention, Comparator, and Outcomes framework to retrieve relevant publications from 4 databases: PubMed, CINAHL, Scopus, and Web of Science. We used the Joanna Briggs Institute's criteria for economic evaluation and randomized controlled trials to assess the risk of bias in the studies. Two researchers independently screened, assessed the quality, and extracted data from the studies selected for the review.ResultsIn total, 20 studies published between 2003 and 2021 fulfilled our inclusion criteria. All the studies were conducted in high-income countries. These studies used telephones, SMS text messaging, mobile health apps, and websites as digital tools for behavior change communication. Most digital tools for interventions focused on diet and nutrition (17/20, 85%) and physical activity (16/20, 80%), and a few focused on smoking and tobacco control (8/20, 40%), alcohol reduction (6/20, 30%), and reduction of salt intake (3/20, 15%). Most studies (17/20, 85%) used the health care payer perspective for economic analysis, and only 15% (3/20) used the societal perspective. Only 45% (9/20) of studies conducted a full economic evaluation. Most studies (7/20, 35%) based on full economic evaluation and 30% (6/20) of studies based on partial economic evaluation found digital health interventions to be cost-effective and cost-saving. Most studies had short follow-ups and failed to include proper indicators for economic evaluation, such as quality-adjusted life-years, disability-adjusted life-years, lack of discounting, and sensitivity analysis.ConclusionsDigital health interventions for behavioral change among people with chronic diseases are cost-effective in high-income settings and can therefore be scaled up. Similar evidence from low- and middle-income countries based on properly designed studies for cost-effectiveness evaluation is urgently required. A full economic evaluation is needed to provide robust evidence for the cost-effectiveness of digital health interventions and their potential for scaling up in a wider population. Future studies should follow the National Institute for Health and Clinical Excellence recommendations to take a societal perspective, apply discounting, address parameter uncertainty, and apply a lifelong time horizon.

Project description:IntroductionType 2 diabetes mellitus (T2DM) remains one of the most common chronic diseases of adulthood which creates high degrees of morbidity and mortality worldwide. The incidence of T2DM continues to rise and recently, mHealth interventions have been increasingly used in the prevention, monitoring and management of T2DM. The aim of this study is to systematically review the published evidence on cost and cost-effectiveness of mHealth interventions for T2DM, as well as assess the quality of reporting of the evidence.Methods and analysisA comprehensive review of PubMed, EMBASE, Science Direct and Web of Science of articles published until January 2019 will be conducted. Included studies will be partial or full economic evaluations which provide cost or cost-effectiveness results for mHealth interventions targeting individuals diagnosed with, or at risk of, T2DM. The quality of reporting evidence will be assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Results will be presented using a flowchart following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. Graphical and tabulated representations of the results will be created for both descriptive and numerical results. The cost and cost-effectiveness values will be presented as reported by the original studies as well as converted into international dollars to allow comparability. As we are predicting heterogenous results, we will conduct a narrative and interpretive analysis of the data.Ethics and disseminationNo formal approval or review of ethics is required for this systematic review as it will involve the collection and analysis of secondary data. This protocol follows the current PRISMA-P guidelines. The review will provide information on the cost and cost-effectiveness of mHealth interventions targeting T2DM. These results will be disseminated through publication and submission to conferences for presentations and posters.Prospero registration numberCRD42019123476.

Project description:The objectives of this study were to evaluate the efficacy of several knowledge-transfer interventions about donkey health, utilizing a cluster-randomized controlled trial (c-RCT), on the long-term knowledge change (~6 months post intervention) of Ethiopian rural working equid owners. Knowledge transfer interventions included: an audio programme, a village meeting and a diagrammatic hand-out, which were also compared to a control group, which received no intervention. All interventions addressed identical learning objectives. Thirty-two villages were randomly selected and interventions randomly assigned to blocks of eight villages. All participants in a village received the same intervention, and knowledge levels were assessed by questionnaire administration both pre and post intervention. Data analysis included multilevel linear and logistic regression models (allowing for clustering of individuals within villages) to evaluate the change in knowledge between the different knowledge-transfer interventions, and to look at other factors associated with change in knowledge. A total of 516 randomly selected participants completed pre-intervention questionnaires, 476 undertook a post-dissemination questionnaire ~6 months later, a follow-up response rate of 92%. All interventions significantly improved the overall knowledge score on the post intervention questionnaire compared to the control group, with the diagrammatic hand-out [coefficient (coef) 10.0, S.E. = 0.5] and the village meeting (coef 8.5, S.E = 0.5) having a significantly greater impact than the audio programme (coef 4.0, S.E = 0.5). There were differences in learning across interventions, learning objectives, age and education levels of the participants. Participants with higher levels of formal education had greater knowledge change but this varied across interventions. In conclusion, knowledge of donkey health was substantially increased by a diagrammatic hand-out and the impact of this simple, low-cost intervention should be further evaluated in other communities in low-income countries. This study should assist in the design and development of effective knowledge-transfer materials for adult learning for rural villagers in low-income countries.

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Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients--the INDICA study: a cluster randomized controlled trial.

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Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients--the INDICA study: a cluster randomized controlled trial.

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