Dataset Information

Evaluating the effectiveness of an empowerment program for self-care in type 2 diabetes: a cluster randomized trial.

ABSTRACT:

Background

The prevalence of type 2 diabetes mellitus is increasing substantially worldwide, leading to serious economic effects, complications and deaths. This study evaluated the effectiveness of an empowerment program providing support for psychosocial, behavioral, and clinical aspects of diabetes to help Brazilian users of public health services obtain metabolic control of this condition.

Methods

In this cluster randomized trial, participants aged 30-80 diagnosed with type 2 diabetes were recruited from ten Brazilian public health units in 2014 and 2015. Five units were randomly assigned to receive the empowerment program based on a behavior change protocol, and five continued to receive only conventional treatment. The primary outcome was the biochemical and anthropometric parameters, and the secondary outcomes were self-care, attitude, knowledge and empowerment related to diabetes. The effect of the experiment was defined as the percentage variation between the values at the initial and final periods. To evaluate this effect and to compare it in the two groups, tests were used for paired and independent samples, respectively.

Results

There were 238 participants: 127 and 111 in the intervention and control group, respectively. For glycated hemoglobin, the mean effect in the control and intervention groups was 3.93 and -5.13, respectively (p < 0.001). Levels of glycated hemoglobin and other metabolic indicators, as well as the most part of the secondary outcomes showed a significant difference in the experimental group compared to the control group.

Conclusions

The empowerment program improved metabolic control of type 2 diabetes in Brazilian users.

Trial registration

NCT02132338 - April 22, 2014.

SUBMITTER: Cortez DN

PROVIDER: S-EPMC5219728 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Publications

Evaluating the effectiveness of an empowerment program for self-care in type 2 diabetes: a cluster randomized trial.

Cortez Daniel Nogueira DN Macedo Maísa Mara Lopes MM Souza Débora Aparecida Silva DA Dos Santos Jéssica Caroline JC Afonso Gesana Sousa GS Reis Ilka Afonso IA Torres Heloísa de Carvalho HC

BMC public health 20170106 1

<h4>Background</h4>The prevalence of type 2 diabetes mellitus is increasing substantially worldwide, leading to serious economic effects, complications and deaths. This study evaluated the effectiveness of an empowerment program providing support for psychosocial, behavioral, and clinical aspects of diabetes to help Brazilian users of public health services obtain metabolic control of this condition.<h4>Methods</h4>In this cluster randomized trial, participants aged 30-80 diagnosed with type 2 d ...[more]

PMID: 28061840

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Project description:ImportanceStrategies that enhance self-care of patients with heart failure reduce mortality and health care use.ObjectiveTo examine whether an empowerment-based self-care education program was more effective and cost-effective to improve self-care, health status, and hospital service use than a didactic education program in patients with heart failure.Design, setting, and participantsIn this double-blind randomized clinical trial, a consecutive sample of 988 patients with heart failure from the cardiac clinics of 2 regional hospitals underwent eligibility screening from February 1, 2017, to May 31, 2019, using the criteria of age of 55 years or older, heart failure diagnosed 6 months before screening, and New York Heart Association class II to IV. A total of 236 participants were randomized to the empowerment (n = 118) or education (n = 118) group.InterventionsThe 12-week, group-based, empowerment-based education program included self-care assessment, goal-orientated actions in symptom recognition and response, fluid and dietary modification, and lifestyle management. Didactic education covered the same topics without empowerment strategies.Main outcomes and measuresThe primary outcome was self-care measured by the Self-care Heart Failure Index (SCHFI) maintenance, management, and symptom perception subscales at posttest and 3-month end points. Secondary outcomes included measures of knowledge, confidence, health-related quality of life, and health service use. Direct, indirect, and social costs of the 2 programs were collected for cost-effectiveness analysis.ResultsA total of 236 Chinese patients (mean [SD] age, 70 [8.0] years; 149 [63.1%] men) were included in the study. The empowerment group reported significantly greater improvement in SCHFI management scores (mean difference, 13.76; 95% CI, 5.89-21.62; Cohen d = 0.46 at posttest and Cohen d = 0.35 at 3 months) and symptom perception scores (mean difference, 20.36; 95% CI, 13.98-26.75; Cohen d = 0.84 at posttest and Cohen d = 0.61 at 3 months). The empowerment group had lower risks of emergency department attendance (incidence rate ratio, 0.55; 95% CI, 0.31-0.95; P = .03) and hospital admission (incidence rate ratio, 0.38; 95% CI, 0.21-0.68; P = .001) and better improved self-care knowledge (change in score [empowerment minus education], 1.29; 95% CI, 0.48-2.09) and confidence (change in score [empowerment minus education], 7.98; 95% CI, 1.91-14.05). Empowerment was cost-saving and cost-effective at T2 compared with the education group for quality-adjusted life-years, with an incremental cost-effectiveness ratio of -114 485.Conclusion and relevanceIn this randomized clinical trial, an empowerment approach led to clinically relevant improvement in symptom perception and self-care management among patients with heart failure. Its cost-effectiveness in improving these prognostic factors also benefits the patient-reported outcome.Trial registrationChinese Clinical Trial Registry: ChiCTR-IOR-16008254.

Project description:Five to 25 percent of residents in aged care settings have a combined hearing and visual sensory impairment. Usual care is generally restricted to single sensory impairment, neglecting the consequences of dual sensory impairment on social participation and autonomy. The aim of this study is to evaluate the effectiveness of a self-management program for seniors who acquired dual sensory impairment at old age.In a cluster randomized, single-blind controlled trial, with aged care settings as the unit of randomization, the effectiveness of a self-management program will be compared to usual care. A minimum of 14 and maximum of 20 settings will be randomized to either the intervention cluster or the control cluster, aiming to include a total of 132 seniors with dual sensory impairment. Each senior will be linked to a licensed practical nurse working at the setting. During a five to six month intervention period, nurses at the intervention clusters will be trained in a self-management program to support and empower seniors to use self-management strategies. In two separate diaries, nurses keep track of the interviews with the seniors and their reflections on their own learning process. Nurses of the control clusters offer care as usual. At senior level, the primary outcome is the social participation of the seniors measured using the Hearing Handicap Questionnaire and the Activity Card Sort, and secondary outcomes are mood, autonomy and quality of life. At nurse level, the outcome is job satisfaction. Effectiveness will be evaluated using linear mixed model analysis.The results of this study will provide evidence for the effectiveness of the Self-Management Program for seniors with dual sensory impairment living in aged care settings. The findings are expected to contribute to the knowledge on the program's potential to enhance social participation and autonomy of the seniors, as well as increasing the job satisfaction of the licensed practical nurses. Furthermore, an extensive process evaluation will take place which will offer insight in the quality and feasibility of the sampling and intervention process. If it is shown to be effective and feasible, this Self-Management Program could be widely disseminated.ClinicalTrials.gov, NCT01217502.

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.

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Dataset Information

Evaluating the effectiveness of an empowerment program for self-care in type 2 diabetes: a cluster randomized trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

Evaluating the effectiveness of an empowerment program for self-care in type 2 diabetes: a cluster randomized trial.

Similar Datasets

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