Dataset Information

REDEEM: a pragmatic trial to reduce diabetes distress.

ABSTRACT: To compare three interventions to reduce diabetes distress (DD) and improve self-management among non-clinically depressed adults with type 2 diabetes mellitus (T2DM).In REDEEM, 392 adults with T2DM and DD were randomized to computer-assisted self-management (CASM), CASM plus DD-specific problem solving (CAPS), or a computer-administered minimal supportive intervention. Primary outcomes were Diabetes Distress Scale (DDS) total, the Emotional Burden (EB) and Regimen Distress (RD) DDS subscales, and diet, exercise, and medication adherence.Significant and clinically meaningful reductions in DD (DDS, EB, and RD) and self-management behaviors occurred in all three conditions (P < 0.001), with no significant between-group differences. There was, however, a significant group × baseline distress interaction (P < 0.02), in which patients with high baseline RD in the CAPS condition displayed significantly larger RD reductions than those in the other two conditions. RD generated the most distress and displayed the greatest distress reduction as a result of intervention. The pace of DD reduction varied by patient age: older patients demonstrated significant reductions in DD early in the intervention, whereas younger adults displayed similar reductions later. Reductions in DD were accompanied by significant improvements in healthy eating, physical activity, and medication adherence, although not by change in HbA1c.DD is malleable and highly responsive to intervention. Interventions that enhance self-management also reduce DD significantly, but DD-specific interventions may be necessary for patients with high initial levels of DD. Future research should identify the minimal, most cost-effective interventions to reduce DD and improve self-management.

SUBMITTER: Fisher L

PROVIDER: S-EPMC3747867 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

REDEEM: a pragmatic trial to reduce diabetes distress.

Fisher Lawrence L Hessler Danielle D Glasgow Russell E RE Arean Patricia A PA Masharani Umesh U Naranjo Diana D Strycker Lisa A LA

Diabetes care 20130604 9

<h4>Objective</h4>To compare three interventions to reduce diabetes distress (DD) and improve self-management among non-clinically depressed adults with type 2 diabetes mellitus (T2DM).<h4>Research design and methods</h4>In REDEEM, 392 adults with T2DM and DD were randomized to computer-assisted self-management (CASM), CASM plus DD-specific problem solving (CAPS), or a computer-administered minimal supportive intervention. Primary outcomes were Diabetes Distress Scale (DDS) total, the Emotional ...[more]

PMID: 23735726

Similar Datasets

Project description:BackgroundThis report describes how we refined a protocol for a pragmatic comparative effectiveness study of two models of an evidence-based diabetes shared medical appointment intervention and used the PRECIS-2 rating system to evaluate these adaptations.MethodsWe report primary data collected between June and August 2019, and protocol refinements completed between 2018 and 2020. Twenty-two members of the study team collaborated in protocol refinement and completed the PRECIS-2 ratings of study pragmatism. We discuss study design refinements made to achieve the desired level of pragmatism vs. experimental control for each of the nine PRECIS-2 dimensions. Study team members received training on PRECIS-2 scoring and were asked to rate the study protocol on the nine PRECIS-2 dimensions. Ratings were compared using descriptive statistics.ResultsIn general, the PRECIS-2 ratings revealed high levels of pragmatism, but somewhat less pragmatic ratings on the categories of Delivery and Organization (costs and resources). This variation was purposeful, and we provide the rationale for and steps taken to obtain the targeted level of pragmatism on each PRECIS-2 dimension, as well as detail design changes made to a) make the design more pragmatic and b) address COVID-19 issues. There was general agreement among team members and across different types of stakeholders on PRECIS-2 ratings.ConclusionsWe discuss lessons learned from use of PRECIS-2 and experiences in refining the study to be maximally pragmatic on some dimensions and less so on other dimensions. This paper expands on prior research by describing actions to achieve higher levels of pragmatism and revise our protocol fit to the changed context. We make recommendations for future use of PRECIS-2 to help address changing context and other strategies for the planning of and transparent reporting on pragmatic research and comparative effectiveness research.Trial registrationClinicaltrials.gov Registration ID: NCT03590041 .

Project description:BackgroundFollowing the introduction of a computerised diabetes register in part of the northeast of England, care initially improved but then plateaued. We therefore enhanced the existing diabetes register to address these problems. The aim of the trial was to evaluate the effectiveness and efficiency of an area wide 'extended,' computerised diabetes register incorporating a full structured recall and management system, including individualised patient management prompts to primary care clinicians based on locally-adapted, evidence-based guidelines.MethodsThe study design was a pragmatic, cluster randomised controlled trial, with the general practice as the unit of randomisation. Set in 58 general practices in three Primary Care Trusts in the northeast of England, the study outcomes were the clinical process and outcome variables held on the diabetes register, patient-reported outcomes, and service and patient costs. The effect of the intervention was estimated using generalised linear models with an appropriate error structure. To allow for the clustering of patients within practices, population averaged models were estimated using generalized estimating equations.ResultsPatients in intervention practices were more likely to have at least one diabetes appointment recorded (OR 2.00, 95% CI 1.02, 3.91), to have a recording of a foot check (OR 1.87, 95% CI 1.09, 3.21), have a recording of receiving dietary advice (OR 2.77, 95% CI 1.22, 6.29), and have a recording of blood pressure (BP) (OR 2.14, 95% CI 1.06, 4.36). There was no difference in mean HbA1c or BP levels, but the mean cholesterol level in patients from intervention practices was significantly lower (-0.15 mmol/l, 95% CI -0.25, -0.06). There were no differences in patient-reported outcomes or in patient-reported use of drugs, or uptake of health services. The average cost per patient was not significantly different between the intervention and control groups. Costs incurred in administering the system at the register and in general practice were in addition to these.ConclusionThis study has shown benefits from an area-wide, computerised diabetes register incorporating a full structured recall and individualised patient management system. However, these benefits were achieved at a cost. In future, these costs may fall as electronic data exchange becomes a reliable reality.Trial registrationInternational Standard Randomised Controlled Trial Number (ISRCTN) Register, ISRCTN32042030.

Project description:OBJECTIVE:To evaluate the effectiveness of a telephonic medication therapy management (MTM) service on reducing hospitalizations among home health patients. SETTING:Forty randomly selected, geographically diverse home health care centers in the United States. DESIGN:Two-stage, randomized, controlled trial with 60-day follow-up. All Medicare- insured home health care patients were eligible to participate. Twenty-eight consecutive patients within each care center were recruited and randomized to usual care or MTM intervention. The MTM intervention consisted of the following: (1) initial phone call by a pharmacy technician to verify active medications; (2) pharmacist-provided medication regimen review by telephone; and (3) follow-up pharmacist phone calls at day seven and as needed for 30 days. The primary outcome was 60-day all-cause hospitalization. DATA COLLECTION:Data were collected from in-home nursing assessments using the OASIS-C. Multivariate logistic regression modeled the effect of the MTM intervention on the probability of hospitalization while adjusting for patients' baseline risk of hospitalization, number of medications taken daily, and other OASIS-C data elements. PRINCIPAL FINDINGS:A total of 895 patients (intervention n = 415, control n = 480) were block-randomized to the intervention or usual care. There was no significant difference in the 60-day probability of hospitalization between the MTM intervention and control groups (Adjusted OR: 1.26, 95 percent CI: 0.89-1.77, p = .19). For patients within the lowest baseline risk quartile (n = 232), the intervention group was three times more likely to remain out of the hospital at 60 days (Adjusted OR: 3.79, 95 percent CI: 1.35-10.57, p = .01) compared to the usual care group. CONCLUSIONS:This MTM intervention may not be effective for all home health patients; however, for those patients with the lowest-risk profile, the MTM intervention prevented patients from being hospitalized at 60 days.

Project description:RationaleCommunication with family of critically ill patients is often poor and associated with family distress.ObjectivesTo determine if an intensive care unit (ICU) communication facilitator reduces family distress and intensity of end-of-life care.MethodsWe conducted a randomized trial at two hospitals. Eligible patients had a predicted mortality greater than or equal to 30% and a surrogate decision maker. Facilitators supported communication between clinicians and families, adapted communication to family needs, and mediated conflict.Measurements and main resultsOutcomes included depression, anxiety, and post-traumatic stress disorder (PTSD) among family 3 and 6 months after ICU and resource use. We identified 488 eligible patients and randomized 168. Of 352 eligible family members, 268 participated (76%). Family follow-up at 3 and 6 months ranged from 42 to 47%. The intervention was associated with decreased depressive symptoms at 6 months (P = 0.017), but there were no significant differences in psychological symptoms at 3 months or anxiety or PTSD at 6 months. The intervention was not associated with ICU mortality (25% control vs. 21% intervention; P = 0.615) but decreased ICU costs among all patients (per patient: $75,850 control, $51,060 intervention; P = 0.042) and particularly among decedents ($98,220 control, $22,690 intervention; P = 0.028). Among decedents, the intervention reduced ICU and hospital length of stay (28.5 vs. 7.7 d and 31.8 vs. 8.0 d, respectively; P < 0.001).ConclusionsCommunication facilitators may be associated with decreased family depressive symptoms at 6 months, but we found no significant difference at 3 months or in anxiety or PTSD. The intervention reduced costs and length of stay, especially among decedents. This is the first study to find a reduction in intensity of end-of-life care with similar or improved family distress. Clinical trial registered with www.clinicaltrials.gov (NCT 00720200).

Dataset Information

REDEEM: a pragmatic trial to reduce diabetes distress.

Publications

REDEEM: a pragmatic trial to reduce diabetes distress.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure