Dataset Information

Effectiveness of Internet-Based Multicomponent Interventions for Patients and Health Care Professionals to Improve Clinical Outcomes in Type 2 Diabetes Evaluated Through the INDICA Study: Multiarm Cluster Randomized Controlled Trial.

ABSTRACT:

Background

Type 2 diabetes mellitus (T2DM) is a chronic disease in which health outcomes are related to decision making by patients and health care professionals.

Objective

This study aims to assess the effectiveness of internet-based multicomponent interventions to support decision making of all actors involved in the care of patients with T2DM in primary care.

Methods

The INDICA study is an open, community-based, multicenter trial with random allocation to usual care or the intervention for patients, the intervention for health care professionals in primary care, or the combined intervention for both. In the intervention for patients, participants received an educational group program and were monitored and supported by logs, a web-based platform, and automated SMS. Those in the intervention for professionals also received an educational program, a decision support tool embedded in the electronic clinical record, and periodic feedback about patients' results. A total of 2334 people with T2DM, regardless of glycated hemoglobin (HbA_1c) levels and without diabetes-related complications, were included. The primary end point was change in HbA_1c level. The main analysis was performed using multilevel mixed models.

Results

For the overall sample, the intervention for patients attained a significant mean reduction in HbA_1c levels of ?0.27 (95% CI ?0.45 to ?0.10) at month 3 and ?0.26 (95% CI ?0.44 to ?0.08) at month 6 compared with usual care, which remained marginally significant at month 12. A clinically relevant reduction in HbA_1c level was observed in 35.6% (191/537) of patients in the intervention for patients and 26.0% (152/586) of those in usual care at month 12 (P=.006). In the combined intervention, HbA_1c reduction was significant until month 18 (181/557, 32.6% vs 140/586, 23.9%; P=.009). Considering the subgroup of patients uncontrolled at baseline, all interventions produced significant reductions in HbA_1c levels across the entire study period: ?0.49 (95% CI ?0.70 to ?0.27) for the intervention for patients, ?0.35 (95% CI ?0.59 to ?0.14) for the intervention for professionals, and ?0.35 (95% CI ?0.57 to ?0.13) for the combined intervention. Differences in HbA_1c for the area under the curve considering the entire period were significant for the intervention for patients and the combined intervention compared with usual care (P=.03 for both). Compared with usual care, the intervention for professionals and the combined intervention had significant longer-term reductions in systolic and diastolic blood pressure.

Conclusions

In uncontrolled patients, the intervention for patients at baseline provided clinically relevant and significant longer-term reductions of HbA_1c levels. The intervention for professionals and combined intervention also improved the cardiovascular risk profile of patients.

Trial registration

ClinicalTrials.gov NCT01657227; https://clinicaltrials.gov/ct2/show/NCT01657227.

SUBMITTER: Ramallo-Farina Y

PROVIDER: S-EPMC7669446 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of Internet-Based Multicomponent Interventions for Patients and Health Care Professionals to Improve Clinical Outcomes in Type 2 Diabetes Evaluated Through the INDICA Study: Multiarm Cluster Randomized Controlled Trial.

Ramallo-Fariña Yolanda Y García-Bello Miguel Angel MA García-Pérez Lidia L Boronat Mauro M Wägner Ana M AM Rodríguez-Rodríguez Leticia L de Pablos-Velasco Pedro P Llorente Gómez de Segura Ignacio I González-Pacheco Himar H Carmona Rodríguez Montserrat M Serrano-Aguilar Pedro P

JMIR mHealth and uHealth 20201102 11

<h4>Background</h4>Type 2 diabetes mellitus (T2DM) is a chronic disease in which health outcomes are related to decision making by patients and health care professionals.<h4>Objective</h4>This study aims to assess the effectiveness of internet-based multicomponent interventions to support decision making of all actors involved in the care of patients with T2DM in primary care.<h4>Methods</h4>The INDICA study is an open, community-based, multicenter trial with random allocation to usual care or t ...[more]

PMID: 33136059

Similar Datasets

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:ImportanceDelirium, an acute disorder with high morbidity and mortality, is often preventable through multicomponent nonpharmacological strategies. The efficacy of these strategies for preventing subsequent adverse outcomes has been limited to small studies to date.ObjectiveTo evaluate available evidence on multicomponent nonpharmacological delirium interventions in reducing incident delirium and preventing poor outcomes associated with delirium.Data sourcesPubMed, Google Scholar, ScienceDirect, and the Cochrane Database of Systematic Reviews from January 1, 1999, to December 31, 2013.Study selectionStudies examining the following outcomes were included: delirium incidence, falls, length of stay, rate of discharge to a long-term care institution (institutionalization), and change in functional or cognitive status.Data extraction and synthesisTwo experienced physician reviewers independently and blindly abstracted data on outcome measures using a standardized approach. The reviewers conducted quality ratings based on the Cochrane risk-of-bias criteria for each study.Main outcomes and measuresWe identified 14 interventional studies. The results for outcomes of delirium incidence, falls, length of stay, and institutionalization were pooled for the meta-analysis, but heterogeneity limited our meta-analysis of the results for change in functional or cognitive status. Overall, 11 studies demonstrated significant reductions in delirium incidence (odds ratio [OR], 0.47; 95% CI, 0.38-0.58). Four randomized or matched trials reduced delirium incidence by 44% (OR, 0.56; 95% CI, 0.42-0.76). The rate of falls decreased significantly among intervention patients in 4 studies (OR, 0.38; 95% CI, 0.25-0.60); in 2 randomized or matched trials, the rate of falls was reduced by 64% (OR, 0.36; 95% CI, 0.22-0.61). Length of stay and institutionalization also trended toward decreases in the intervention groups, with a mean difference of -0.16 (95% CI, -0.97 to 0.64) day shorter and the odds of institutionalization 5% lower (OR, 0.95; 95% CI, 0.71-1.26). Among higher-quality randomized or matched trials, length of stay trended -0.33 (95% CI, -1.38 to 0.72) day shorter, and the odds of institutionalization trended 6% lower (OR, 0.94; 95% CI, 0.69-1.30).Conclusions and relevanceMulticomponent nonpharmacological delirium prevention interventions are effective in reducing delirium incidence and preventing falls, with a trend toward decreasing length of stay and avoiding institutionalization. Given the current focus on prevention of hospital-based complications and improved cost-effectiveness of care, this meta-analysis supports the use of these interventions to advance acute care for older persons.

Project description:BackgroundHypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in low-income and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback.MethodsUsing a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness.DiscussionWe will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs.Trial registrationClinicalTrials.gov: NCT03504124. Registered on 20 April 2018.

Project description: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.

Project description:BACKGROUND:Supporting women to initiate and continue breastfeeding is a global challenge. A range of breastfeeding interventions employing electronic technologies (e-technologies) are being developed, which offer different delivery modes and features over the internet; however, the impact of internet-based e-technologies on breastfeeding outcomes remains unclear. OBJECTIVE:This study aimed to identify the characteristics of current internet-based breastfeeding interventions employing e-technologies and investigate the effects of internet-based e-technologies on breastfeeding outcomes. METHODS:A systematic search was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines in the following databases: Scopus, Web of Science, the Cochrane Database of Systematic Reviews, ScienceDirect, Google Scholar, the Association for Computing Machinery, SpringerLink, and Institute of Electrical and Electronics Engineers Xplore. RESULTS:This systematic review included 16 studies published between 2007 and 2018, with 4018 women in 8 countries. The characteristics of the interventions were grouped based on (1) mode of delivery (web-based, mobile phone apps, and computer kiosk), (2) purpose of the interventions (education and support), and (3) key strategies (monitoring and breastfeeding tracking, personalization, online discussion forum, web-based consultation, and breastfeeding station locators). Combining educational activities with web-based personalized support through discussion forums appeared to be the most effective way to improve breastfeeding outcomes and long-term exclusive breastfeeding rates. Monitoring and breastfeeding trackers appeared to be the least effective ways. CONCLUSIONS:This study demonstrated a variety of internet-based e-technologies that professionals can use to promote, educate, and support breastfeeding women. Future internet-based breastfeeding interventions employing e-technologies might consider improving interaction with mothers and personalizing the content of the proposed interventions.

Project description:BackgroundMedical professionals are exposed to multiple and often excessive demands in their work environment. Low-intensity internet interventions allow them to benefit from psychological support even when institutional help is not available. Focusing on enhancing psychological resources-self-efficacy and perceived social support-makes an intervention relevant for various occupations within the medical profession. Previously, these resources were found to operate both individually or sequentially with self-efficacy either preceding social support (cultivation process) or following it (enabling process).ObjectiveThe objective of this randomized controlled trial is to compare the efficacy of 4 variants of Med-Stress, a self-guided internet intervention that aims to improve the multifaceted well-being of medical professionals.MethodsThis study was conducted before the COVID-19 pandemic. Participants (N=1240) were recruited mainly via media campaigns and social media targeted ads. They were assigned to 1 of the following 4 groups: experimental condition reflecting the cultivation process, experimental condition reflecting the enabling process, active comparator enhancing only self-efficacy, and active comparator enhancing only perceived social support. Outcomes included 5 facets of well-being: job stress, job burnout, work engagement, depression, and job-related traumatic stress. Measurements were taken on the web at baseline (time 1), immediately after intervention (time 2), and at a 6-month follow-up (time 3). To analyze the data, linear mixed effects models were used on the intention-to-treat sample. The trial was partially blinded as the information about the duration of the trial, which was different for experimental and control conditions, was public.ResultsAt time 2, job stress was lower in the condition reflecting the cultivation process than in the one enhancing social support only (d=-0.21), and at time 3, participants in that experimental condition reported the lowest job stress when compared with all 3 remaining study groups (ds between -0.24 and -0.41). For job-related traumatic stress, we found a significant difference between study groups only at time 3: stress was lower in the experimental condition in which self-efficacy was enhanced first than in the active comparator enhancing solely social support (d=-0.24). The same result was found for work engagement (d=-0.20), which means that it was lower in exactly the same condition that was found beneficial for stress relief. There were no differences between study conditions for burnout and depression neither at time 2 nor at time 3. There was a high dropout in the study (1023/1240, 82.50% at posttest), reflecting the pragmatic nature of this trial.ConclusionsThe Med-Stress internet intervention improves some components of well-being-most notably job stress-when activities are completed in a specific sequence. The decrease in work engagement could support the notion of dark side of this phenomenon, but further research is needed.Trial registrationClinicalTrials.gov NCT03475290; https://clinicaltrials.gov/ct2/show/NCT03475290.International registered report identifier (irrid)RR2-10.1186/s13063-019-3401-9.

Dataset Information

Effectiveness of Internet-Based Multicomponent Interventions for Patients and Health Care Professionals to Improve Clinical Outcomes in Type 2 Diabetes Evaluated Through the INDICA Study: Multiarm Cluster Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

Publications

Effectiveness of Internet-Based Multicomponent Interventions for Patients and Health Care Professionals to Improve Clinical Outcomes in Type 2 Diabetes Evaluated Through the INDICA Study: Multiarm Cluster Randomized Controlled Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets