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Rationale and design: telephone-delivered behavioral skills interventions for Blacks with Type 2 diabetes.

ABSTRACT: African Americans with Type 2 diabetes (T2DM) have higher prevalence of diabetes, poorer metabolic control, and greater risk for complications and death compared to American Whites. Poor outcomes in African Americans with T2DM can be attributed to patient, provider, and health systems level factors. Provider and health system factors account for <10% of variance in major diabetes outcomes including hemoglobin A1c (HbA1c), lipid control, and resource use. Key differences appear to be at the patient level. Of the patient level factors, consistent differences between African Americans and American Whites with T2DM have been found in diabetes knowledge, self-management skills, empowerment, and perceived control. A variety of interventions to improve diabetes self-management have been tested including: 1) knowledge interventions; 2) lifestyle interventions; 3) skills training interventions; and 4) patient activation and empowerment interventions. Most of these interventions have been tested individually, but rarely have they been tested in combination, especially among African Americans who have the greatest burden of diabetes related complications. This study provides a unique opportunity to address this gap in the literature.We describe an ongoing four-year randomized clinical trial, using a 2 x 2 factorial design, which will test the efficacy of separate and combined telephone-delivered, diabetes knowledge/information and motivation/behavioral skills training interventions in high risk African Americans with poorly controlled T2DM (HbA1c >or= 9%). Two-hundred thirty-two (232) male and female African-American participants, 18 years of age or older and with an HbA1c >or= 9%, will be randomized into one of four groups for 12-weeks of phone interventions: (1) an education group, (2) a motivation/skills group, (3) a combined group or (4) a usual care/general health education group. Participants will be followed for 12-months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that among African Americans with poorly controlled T2DM, patients randomized to the combined diabetes knowledge/information and motivation/behavioral skills training intervention will have significantly greater reduction in HbA1c at 12 months of follow-up compared to the usual care/general health education group.Results from this study will provide important insight into how best to deliver diabetes education and skills training in ethnic minorities and whether combined knowledge/information and motivation/behavioral skills training is superior to the usual method of delivering diabetes education for African Americans with poorly controlled T2DM.National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT00929838).

SUBMITTER: Egede LE

PROVIDER: S-EPMC2855561 | biostudies-literature | 2010 Mar

REPOSITORIES: biostudies-literature

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Rationale and design: telephone-delivered behavioral skills interventions for Blacks with Type 2 diabetes.

Egede Leonard E LE Strom Joni L JL Durkalski Valerie L VL Mauldin Patrick D PD Moran William P WP

Trials 20100329

<h4>Background</h4>African Americans with Type 2 diabetes (T2DM) have higher prevalence of diabetes, poorer metabolic control, and greater risk for complications and death compared to American Whites. Poor outcomes in African Americans with T2DM can be attributed to patient, provider, and health systems level factors. Provider and health system factors account for <10% of variance in major diabetes outcomes including hemoglobin A1c (HbA1c), lipid control, and resource use. Key differences appear ...[more]

PMID: 20350322

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Project description:BackgroundDiabetes disproportionately affects African Americans and is associated with poorer outcomes. Self-management is important for glycemic control; however, evidence in African Americans is limited.ObjectiveTo assess the efficacy of a combined telephone-delivered education and behavioral skills intervention (TBSI) in reducing hemoglobin A1c (HbA1c) levels in African Americans with type 2 diabetes, using a factorial design.DesignThis is a four-year randomized clinical trial, using a 2 x 2 factorial design.: Participants: African American adults ≥18 years) with poorly controlled type 2 diabetes (HbA1c ≥9%) were randomly assigned to one of four groups: 1) knowledge only, 2) skills only, 3) combined knowledge and skills (TBSI), or 4) control group.InterventionAll participants received 12 telephone-delivered 30-min intervention sessions specific to their assigned group. Participants were assessed at baseline and 3, 6, and 12 months.Main measureThe primary outcome was HbA1c at 12 months post-randomization in the intent-to-treat (ITT) population.Key resultsTwo hundred fifty-five participants were randomly assigned to the four groups. Based on the ITT population after multiple imputation, the analysis of covariance with baseline HbA1c as the covariate showed that HbA1c at 12 months for the intervention groups did not differ significantly from that of the control group (knowledge: 0.49, p = 0.123; skills: 0.23, p = 0.456; combined: 0.48, p = 0.105). Absolute change from baseline at 12 months for all treatment arms was 0.6. Longitudinal mixed effects analysis showed that, on average, there was a significant decline in HbA1c over time for all treatment groups (-0.07, p < 0.001). However, the rates of decline for the intervention groups were not significantly different from that of the control group (knowledge: 0.06, p = 0.052; skills: 0.02, p = 0.448; combined: 0.05, p = 0.062). Results from per-protocol populations were similar.ConclusionsFor African Americans with poorly controlled type 2 diabetes, combined education and skills training did not achieve greater reductions in glycemic control (i.e., HbA1c levels) at 12 months compared to the control group, education alone, or skills training alone. This trial is registered with ClinicalTrials.gov, identifier no. NCT00929838.

Project description:BackgroundSince 1879, the year of the first documented medical telephone consultation, the ability to consult by telephone has become an integral part of modern patient-centred healthcare systems. Nowadays, upwards of a quarter of all care consultations are conducted by telephone. Studies have quantified the impact of medical telephone consultation on clinicians' workload and detected the need for quality improvement. While doctors routinely receive training in communication and consultation skills, this does not necessarily include the specificities of telephone communication and consultation. Several studies assessed the short-term effect of interventions aimed at improving clinicians' telephone consultation skills, but there is no systematic review reporting patient-oriented outcomes or outcomes of interest to clinicians.ObjectivesTo assess the effects of training interventions for clinicians' telephone consultation skills and patient outcomes.Search methodsWe searched CENTRAL, MEDLINE, Embase, five other electronic databases and two trial registers up to 19 May 2016, and we handsearched references, checked citations and contacted study authors to identify additional studies and data.Selection criteriaWe considered randomised controlled trials, non-randomised controlled trials, controlled before-after studies and interrupted time series studies evaluating training interventions compared with any control intervention, including no intervention, for improving clinicians' telephone consultation skills with patients and their impact on patient outcomes.Data collection and analysisTwo review authors independently selected studies for inclusion, extracted data and assessed the risk of bias of eligible studies using standard Cochrane and EPOC guidance and the certainty of evidence using GRADE. We contacted study authors where additional information was needed. We used standard methodological procedures expected by Cochrane for data analysis.Main resultsWe identified one very small controlled before-after study performed in 1989: this study used a validated tool to assess the effects of a training intervention on paediatric residents' history-taking and case management skills. It reported no difference compared to no intervention, but authors did not report any quantitative analyses and could not supply additional data. We rated this study as being at high risk of bias. Based on GRADE, we assessed the certainty of the evidence as very low, and consequently it is uncertain whether this intervention improves clinicians' telephone skills.We did not find any study assessing the effect of training interventions for improving clinicians' telephone communication skills on patient primary outcomes (health outcomes measured by validated tools or biomedical markers or patient behaviours, patient morbidity or mortality, patient satisfaction, urgency assessment accuracy or adverse events).Authors' conclusionsTelephone consultation skills are part of a wider set of remote consulting skills whose importance is growing as more and more medical care is delivered from a distance with the support of information technology. Nevertheless, no evidence specifically coming from telephone consultation studies is available, and the training of clinicians at the moment has to be guided by studies and models based on face-to-face communication, which do not consider the differences between these two communicative dimensions. There is an urgent need for more research assessing the effect of different training interventions on clinicians' telephone consultation skills and their effect on patient outcomes.

Project description:ImportanceGeneralized anxiety disorder (GAD) is common in older adults; however, access to treatment may be limited, particularly in rural areas.ObjectiveTo examine the effects of telephone-delivered cognitive behavioral therapy (CBT) compared with telephone-delivered nondirective supportive therapy (NST) in rural older adults with GAD.Design, setting, and participantsRandomized clinical trial in the participants' homes of 141 adults aged 60 years and older with a principal or coprincipal diagnosis of GAD who were recruited between January 27, 2011, and October 22, 2013.InterventionsTelephone-delivered CBT consisted of as many as 11 sessions (9 were required) focused on recognition of anxiety symptoms, relaxation, cognitive restructuring, the use of coping statements, problem solving, worry control, behavioral activation, exposure therapy, and relapse prevention, with optional chapters on sleep and pain. Telephone-delivered NST consisted of 10 sessions focused on providing a supportive atmosphere in which participants could share and discuss their feelings and did not provide any direct suggestions for coping.Main outcomes and measuresPrimary outcomes included interviewer-rated anxiety severity (Hamilton Anxiety Rating Scale) and self-reported worry severity (Penn State Worry Questionnaire-Abbreviated) measured at baseline, 2 months' follow-up, and 4 months' follow-up. Mood-specific secondary outcomes included self-reported GAD symptoms (GAD Scale 7 Item) measured at baseline and 4 months' follow-up and depressive symptoms (Beck Depression Inventory) measured at baseline, 2 months' follow-up, and 4 months' follow-up. Among the 141 participants, 70 were randomized to receive CBT and 71 to receive NST.ResultsAt 4 months' follow-up, there was a significantly greater decline in worry severity among participants in the telephone-delivered CBT group (difference in improvement, -4.07; 95% CI, -6.26 to -1.87; P = .004) but no significant differences in general anxiety symptoms (difference in improvement, -1.52; 95% CI, -4.07 to 1.03; P = .24). At 4 months' follow-up, there was a significantly greater decline in GAD symptoms (difference in improvement, -2.36; 95% CI, -4.00 to -0.72; P = .005) and depressive symptoms (difference in improvement, -3.23; 95% CI, -5.97 to -0.50; P = .02) among participants in the telephone-delivered CBT group.Conclusions and relevanceIn this trial, telephone-delivered CBT was superior to telephone-delivered NST in reducing worry, GAD symptoms, and depressive symptoms in older adults with GAD.Trial registrationclinicaltrials.gov Identifier: NCT01259596.

Project description:BackgroundDepression is common among chronic heart failure (CHF) patients, and it is associated with significant re-hospitalization and mortality as well as lower quality of life. While psychotherapy is efficacious treatment for depression, the effect for depression among CHF is uncertain. And barriers preclude widely utility of psychotherapy among the elderly. Telephone-delivered psycho-behavioural intervention specifically focuses on depression among the elderly with CHF, and could be a promising alternative to conventional treatment. The present study was designed to prospectively investigate the effect of a telephone-delivered psycho-behavioural intervention on depression in the elderly with chronic heart failure (CHF).Method/designIn this prospective, multicentre, parallel, randomized, and controlled trial, 236 participants with depression associated with CHF (New York Heart Association classes II and III) will be enrolled. The study will consist of a 12-week intensive intervention and a 24-week maintenance intervention. Eligible participants will be randomized to either the intervention arm or the control arm. During the intensive phase, participants will receive either a guided telephone psycho-behavioural intervention or regular telephone contacts from the counsellors weekly. During the maintenance phase, participants will receive either psychological behavioural support or regular telephone contacts monthly from counsellors. Depressive symptoms, cardiac outcome and quality of life will be assessed at baseline and weeks 1, 2, 4, 8, 12, 24 and 36. Participants will undergo echocardiography and the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP) tested at baseline, weeks 12 and 36. The primary outcome is the response rate of depression, from baseline to week 12. The second outcomes include the change in cardiac function, quality of life and severity of depressive symptoms during the trial.DiscussionTo our knowledge, this study is the first prospective randomized trial to test the effective of the telephone-delivered psycho-behavioural intervention on depression in the elderly with CHF. The findings are expected to provide a new and evidence-based approach for depression among the elderly with CHF.Trial registrationThe trial was registered at www.clinicaltrials.gov (identification number: NCT03233451 ) on 28 July 2017 and updated on 18 August 2017.

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Rationale and design: telephone-delivered behavioral skills interventions for Blacks with Type 2 diabetes.

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Rationale and design: telephone-delivered behavioral skills interventions for Blacks with Type 2 diabetes.

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