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Effect of a self-care educational intervention to improve self-care adherence among patients with chronic heart failure: a clustered randomized controlled trial in Northwest Ethiopia.
Dessie, G, Burrowes, S, Mulugeta, H, Haile, D, Negess, A, Jara, D, Alem, G, Tesfaye, B, Zeleke, H, Gualu, T, et al
BMC cardiovascular disorders. 2021;(1):374
Abstract
BACKGROUND As the burden of cardiovascular disease increases in sub-Saharan Africa, there is a growing need for low-cost interventions to mitigate its impact. Providing self-care health education to patients with chronic heart failure (CHF) is recommended as an intervention to prevent complications, improve quality of life, and reduce financial burdens on fragile health systems. However, little is known about health education's effectiveness at improving CHF self-management adherence in sub-Saharan Africa. Therefore the present study aimed to assess the effectiveness of an educational intervention to improve self-care adherence among patients with CHF at Debre Markos and Felege Hiwot Referral Hospitals in Northwest Ethiopia. METHODS To address this gap, we adapted a health education intervention based on social cognitive theory comprising of intensive four-day training and, one-day follow-up sessions offered every four months. Patients also received illustrated educational leaflets. We then conducted a clustered randomized control trial of the intervention with 186 randomly-selected patients at Debre Markos and Felege Hiwot referral hospitals. We collected self-reported data on self-care behavior before each educational session. We analyzed these data using a generalized estimating equations model to identify health education's effect on a validated 8-item self-care adherence scale. RESULTS Self-care adherence scores were balanced at baseline. After the intervention, patients in the intervention group (n = 88) had higher adherence scores than those in the control group (n = 98). This difference was statistically significant (β = 4.15, p < 0.05) and increased with each round of education. Other factors significantly associated with adherence scores were being single (β = - 0.25, p < 0.05), taking aspirin (β = 0.76, p < 0.05), and having a history of hospitalization (β = 0.91, p < 0.05). CONCLUSIONS We find that self-care education significantly improved self-care adherence scores among CHF patients. This suggests that policymakers should consider incorporating self-care education into CHF management. TRIAL REGISTRATION NUMBER PACTR201908812642231.
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A Single Motivational Lecture Can Promote Modest Weight Loss: A Randomized Controlled Trial.
Nakata, Y, Sasai, H, Tsujimoto, T, Hashimoto, K, Kobayashi, H
Obesity facts. 2020;(2):267-278
Abstract
BACKGROUND Obesity is a public health problem worldwide. To widely disseminate weight-loss interventions across the target population, a cost-effective approach is needed. OBJECTIVE We aimed to test whether a single motivational lecture could promote weight loss. METHODS Our study was a 3-month randomized controlled trial, and we recruited participants via local newspaper advertisements in 3 cities in Ibaraki Prefecture, Japan, and randomly assigned them to a control group (no intervention) and an intervention group, who attended a single motivational lecture lasting approximately 2 h. No other lectures or textbooks were provided. The eligibility criteria included an age of 40-64 years, a body mass index (BMI) of 25-40 kg/m2, and the presence of at least 1 component of metabolic syndrome. The primary outcome was body weight change at 3 months. RESULTS We enrolled 145 eligible participants with a mean age of 53.8 ± 7.1 years and a BMI of 28.5 ± 3.1 kg/m2. The 3-month body weight change in the control and intervention groups was -0.65 kg (95% confidence interval [CI] -1.09 to -0.20) and -2.48 kg (95% CI -3.01 to -1.95), respectively. The between-group difference was 1.83 kg (95% CI 1.15-2.51). CONCLUSIONS The significant difference suggested that a single motivational lecture is an effective option to promote modest weight loss in the short term.
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Effect of a participatory patient education programme (NExt EDucation) in group-based patient education among Danes with type 2 diabetes.
Christoffersen, LA, Hansen, AK, Pals, RA, Willaing, I, Siersma, V, Olesen, K
Chronic illness. 2020;(3):226-236
Abstract
OBJECTIVE To assess the effect of a participatory group-based education programme for individuals with type 2 diabetes, Next Education. METHOD In a quasi-experimental study, individuals with type 2 diabetes were recruited from 14 Danish municipalities with a patient education programme. Eight municipalities using Next Education were intervention sites; six control sites used usual group-based education programmes. Data were collected through questionnaires at baseline and at 3 and 12 months after programmes ended. Changes in quality of life (EQ-5D-5L), diabetes-related emotional distress (PAID-5), physical activity, diet, foot care and sense of coherence (SOC-13) were assessed in generalised linear mixed models. RESULTS At baseline, 310 participants (52.6% females, mean age 62.5 years [SD = 10.7] and a mean duration of type 2 diabetes of 6.9 years [SD = 8.4]) participated in Next Education (n = 234) or group-based education (n = 76) at control sites. Compared with participants at control sites, participants at intervention sites had significantly larger sense of coherence scores at 3 (9.4%, p = 0.03) and 12 (9.8%, p = 0.02) months of follow-up. Other measures did not differ significantly between groups. DISCUSSION It is likely that person-centeredness and high degrees of user participation at the intervention sites improved sense of coherence among Danes with type 2 diabetes.
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Evaluating the Effect of Comprehensive Intervention on Cerebro-Vascular Function in Population at High Risk of Stroke.
Liu, X, Gu, Y, Zhang, Y, Zhang, Y, Tan, X
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association. 2019;(9):2543-2554
Abstract
BACKGROUND Today there exists few intervention researches on cerebro-vascular function in populations at high risk of stroke in China. METHODS Patients more than 40 years old, with at least 1 of stroke risk factors were recruited from outpatient department in 3 hospitals. A quasi-experimental design was performed by assigning participants into 3 groups: comprehensive intervention group, health education group, and control group. Participants in the control group received no intervention but were informed of risk factors of stroke. For health education group, a health education class was performed. Except to the health education program, participants in the comprehensive intervention group received an additional health life and behavior guidance. RESULTS After the intervention, the Cerebro-Vascular Function Scores (CVFS) had significant differences among 3 groups (F = 5.252, P < 0.05). There was a significant increase in CVFS compared to the control group (P = 0.003, 95%CI: 1.552-8.493). Significantly changes in obesity were observed in comprehensive intervention group before and after the intervention (χ2 = 9.0747, P = 0.0026). The results of logistic regression showed that comprehensive intervention group had a significant decrease in prevalence of obesity (OR = 0.482, 95% CI: 0.242-0.961) compared to the control group. CONCLUSION Health education on stroke in a high-risk population combined with guidance on proper health life and behavior can be effective in preventing stroke.
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Structured lifestyle education for people with schizophrenia, schizoaffective disorder and first-episode psychosis (STEPWISE): randomised controlled trial.
Holt, RIG, Gossage-Worrall, R, Hind, D, Bradburn, MJ, McCrone, P, Morris, T, Edwardson, C, Barnard, K, Carey, ME, Davies, MJ, et al
The British journal of psychiatry : the journal of mental science. 2019;(2):63-73
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BACKGROUND Obesity is a major challenge for people with schizophrenia.AimsWe assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia. METHOD In this randomised controlled trial (study registration: ISRCTN19447796), we recruited adults with schizophrenia, schizoaffective disorder or first-episode psychosis from ten mental health organisations in England. Participants were randomly allocated to the STEPWISE intervention or treatment as usual. The 12-month intervention comprised four 2.5 h weekly group sessions, followed by 2-weekly maintenance contact and group sessions at 4, 7 and 10 months. The primary outcome was weight change after 12 months. Key secondary outcomes included diet, physical activity, biomedical measures and patient-related outcome measures. Cost-effectiveness was assessed and a mixed-methods process evaluation was included. RESULTS Between 10 March 2015 and 31 March 2016, we recruited 414 people (intervention 208, usual care 206) with 341 (84.4%) participants completing the trial. At 12 months, weight reduction did not differ between groups (mean difference 0.0 kg, 95% CI -1.6 to 1.7, P = 0.963); physical activity, dietary intake and biochemical measures were unchanged. STEPWISE was well-received by participants and facilitators. The healthcare perspective incremental cost-effectiveness ratio was £246 921 per quality-adjusted life-year gained. CONCLUSIONS Participants were successfully recruited and retained, indicating a strong interest in weight interventions; however, the STEPWISE intervention was neither clinically nor cost-effective. Further research is needed to determine how to manage overweight and obesity in people with schizophrenia.Declaration of interestR.I.G.H. received fees for lecturing, consultancy work and attendance at conferences from the following: Boehringer Ingelheim, Eli Lilly, Janssen, Lundbeck, Novo Nordisk, Novartis, Otsuka, Sanofi, Sunovion, Takeda, MSD. M.J.D. reports personal fees from Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca, Janssen, Servier, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals International Inc.; and, grants from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, Janssen. K.K. has received fees for consultancy and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Servier and Merck Sharp & Dohme. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim and Merck Sharp & Dohme. K.K. has received funds for research, honoraria for speaking at meetings and has served on advisory boards for Lilly, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk. D.Sh. is expert advisor to the NICE Centre for guidelines; board member of the National Collaborating Centre for Mental Health (NCCMH); clinical advisor (paid consultancy basis) to National Clinical Audit of Psychosis (NCAP); views are personal and not those of NICE, NCCMH or NCAP. J.P. received personal fees for involvement in the study from a National Institute for Health Research (NIHR) grant. M.E.C. and Y.D. report grants from NIHR Health Technology Assessment, during the conduct of the study; and The Leicester Diabetes Centre, an organisation (employer) jointly hosted by an NHS Hospital Trust and the University of Leicester and who is holder (through the University of Leicester) of the copyright of the STEPWISE programme and of the DESMOND suite of programmes, training and intervention fidelity framework that were used in this study. S.R. has received honorarium from Lundbeck for lecturing. F.G. reports personal fees from Otsuka and Lundbeck, personal fees and non-financial support from Sunovion, outside the submitted work; and has a family member with professional links to Lilly and GSK, including shares. F.G. is in part funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research & Care Funding scheme, by the Maudsley Charity and by the Stanley Medical Research Institute and is supported by the by the Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.
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The dietary education trial in carbohydrate counting (DIET-CARB Study): study protocol for a randomised, parallel, open-label, intervention study comparing different approaches to dietary self-management in patients with type 1 diabetes.
Ewers, B, Vilsbøll, T, Andersen, HU, Bruun, JM
BMJ open. 2019;(9):e029859
Abstract
INTRODUCTION Clinical guidelines recommend that patients with type 1 diabetes (T1D) learn carbohydrate counting or similar methods to improve glycaemic control. Although systematic educating in carbohydrate counting is still not offered as standard-of-care for all patients on multiple daily injections (MDI) insulin therapy in outpatient diabetes clinics in Denmark. This may be due to the lack of evidence as to which educational methods are the most effective for training patients in carbohydrate counting. The objective of this study is to compare the effect of two different educational programmes in carbohydrate counting with the usual dietary care on glycaemic control in patients with T1D. METHODS AND ANALYSIS The study is designed as a randomised controlled trial with a parallel-group design. The total study duration is 12 months with data collection at baseline, 6 and 12 months. We plan to include 231 Danish adult patients with T1D. Participants will be randomised to one of three dietician-led interventions: (1) a programme in basic carbohydrate counting, (2) a programme in advanced carbohydrate counting including an automated bolus calculator or (3) usual dietary care. The primary outcome is changes in glycated haemoglobin A1c or mean amplitude of glycaemic excursions from baseline to end of the intervention period (week 24) between and within each of the three study groups. Other outcome measures include changes in other parameters of plasma glucose variability (eg, time in range), body weight and composition, lipid profile, blood pressure, mathematical literacy skills, carbohydrate estimation accuracy, dietary intake, diet-related quality of life, perceived competencies in dietary management of diabetes and perceptions of an autonomy supportive dietician-led climate, physical activity and urinary biomarkers. ETHICS AND DISSEMINATION The protocol has been approved by the Ethics Committee of the Capital Region, Copenhagen, Denmark. Study findings will be disseminated widely through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER ClinicalTrials.gov Registry (NCT03623113).
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Assessment of Alimentación Normal con Ajuste de Insulina (ANAIS), a Spanish version of the DAFNE programme, in people with Type 1 diabetes: a randomized controlled parallel trial.
Sánchez-Hernández, RM, Alvarado-Martel, D, López-Plasencia, Y, Carrillo-Domínguez, A, Jiménez-Rodríguez, A, Rodríguez-Cordero, J, Vera-Elzo, T, Santana Del Pino, Á, Nóvoa-Mogollón, FJ, Wägner, AM
Diabetic medicine : a journal of the British Diabetic Association. 2019;(8):1037-1045
Abstract
AIM: To evaluate the effects of Alimentación Normal con Ajuste de Insulina (ANAIS), a group-based, therapeutic education programme for Type 1 diabetes based on a flexible insulin regimen adjusted to the individual's food intake. METHODS Participants with Type 1 diabetes and HbA1c levels of 53-86 mmol/mol (7-10%) were recruited from outpatient clinics at a tertiary care centre. They were randomized (using opaque, sealed envelopes, with a 2:1 treatment allocation ratio) to attend the training course immediately (immediate ANAIS; intervention group) or a year later (delayed ANAIS; control group). The main outcome was HbA1c level at 1 year. Secondary outcomes included lipid levels, weight, hypoglycaemic events, insulin dose, treatment satisfaction, self-perceived dietary freedom, quality of life and participant-defined goals. RESULTS A total of 48 participants were assigned to the intervention group and 32 to the control group. Twelve months after completing the training, adjusted HbA1c was not significantly different in the intervention group [64 ± 1.3 vs 68 ± 1.6 mmol/mol (8.0 ±0.1% vs 8.4 ±0.1%); P=0.081]. Treatment satisfaction was significantly higher in the intervention group, but no differences were found in hypoglycaemic events, weight, insulin dose or changes in dietary freedom. At 1 year after the intervention, 72% of the participants (vs 33% in the control group; P=0.046) reported exceeding their expectations regarding achievement of their main personal goal. CONCLUSION Promoting dietary freedom and empowering people with Type 1 diabetes through structured education programmes, such as ANAIS, improves treatment satisfaction and self-defined goals. No significant improvement in HbA1c level was achieved.
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COPD patients need more information about self-management: a cross-sectional study in Swedish primary care.
Sandelowsky, H, Krakau, I, Modin, S, Ställberg, B, Nager, A
Scandinavian journal of primary health care. 2019;(4):459-467
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Objective: In Sweden, patients with chronic conditions, such as chronic obstructive pulmonary disease (COPD), often receive education at specialized nurse-led clinics at primary health care centers (PHCCs). Identifying patients' needs for information about COPD is the key to individualized care. This study aimed to assess self-reported needs for information about COPD in primary care patients with either moderate (GOLD 2) or severe (GOLD 3) COPD and identify patient characteristics and exacerbation patterns associated with the findings.Design: A cross-sectional study.Setting: Twenty-four PHCCs in Stockholm, Sweden.Subjects: Randomly selected primary care patients with COPD in GOLD stages 2 and 3 (n = 542).Main outcome measures: The Lung Information Needs Questionnaire (LINQ) was used to assess perceived information needs. Spirometry results and descriptive, self-reported data on patient factors such as exacerbation history, treatment, smoking, weight/height, comorbidities, health care contacts, education and symptoms were collected.Results: Overall, the greatest reported needs were for information about self-management and diet. GOLD 2 patients (68%) expressed greater needs for information than GOLD 3 patients (32%). We found significant associations between high information needs and patient-related factors such as 'No assigned GP' (OR = 4.32 [95% CI 2.65-7.05]) and 'No contact with COPD nurse in the past 12 months' (OR = 1.83 [95% CI 1.19-2.81]).Conclusion: COPD patients felt they knew too little about self-management of their disease. Low information needs were strongly associated with continuity in patient-GP consultations and moderately associated with contact with a COPD nurse. These associations were strongest in patients with moderate COPD.Key points: As patients with COPD often have multimorbidity, identifying patients' needs for information about COPD is essential to providing individualized patient education and care. In this study of 542 patients from 24 Swedish primary care centers, we found that:Patients with COPD, particularly those with moderate airflow limitation (i.e. GOLD 2) felt they needed more information about COPD than currently provided by health care professionals in primary care.Low information needs were strongly associated with continuity in patient-GP consultations and moderately associated with contact with a COPD nurse. GPs' part in COPD patient education should not be overlooked, as individualized COPD care relies on GPs' expertise in managing patients with multimorbidity.
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A Targeted Self-Management Approach for Reducing Stroke Risk Factors in African American Men Who Have Had a Stroke or Transient Ischemic Attack.
Sajatovic, M, Tatsuoka, C, Welter, E, Colon-Zimmermann, K, Blixen, C, Perzynski, AT, Amato, S, Cage, J, Sams, J, Moore, SM, et al
American journal of health promotion : AJHP. 2018;(2):282-293
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PURPOSE This study compared a novel self-management (TargetEd MAnageMent Intervention [TEAM]) versus treatment as usual (TAU) to reduce stroke risk in African American (AA) men. DESIGN Six-month prospective randomized controlled trial with outcomes evaluated at baseline, 3 months, and 6 months. SETTING Academic health center. PARTICIPANTS Thirty-eight (age < 65) AA men who had a stroke or transient ischemic attack and a Barthel index score of >60 were randomly assigned to TEAM (n = 19) or TAU (n = 19). INTERVENTION Self-management training, delivered in 1 individual and 4 group sessions (over 3 months). MEASURES Blood pressure, glycosylated hemoglobin (HbA1c), lipids, medication adherence, weight, and standardized measures of health behaviors (diet, exercise, smoking, substances), depression, and quality of life. Qualitative assessments evaluated the perspectives of TEAM participants. ANALYSIS T tests for paired differences and nonparametric tests. Thematic content qualitative analysis. RESULTS Mean age was 52.1 (standard deviation [SD] = 7.4) and mean body mass index was 31.4 (SD = 7.4). Compared to TAU, TEAM participants had significantly lower mean systolic blood pressure by 24 weeks, and there was also improvement in HbA1c and high-density lipoprotein cholesterol ( P = .03). Other biomarker and health behaviors were similar between groups. Qualitative results suggested improved awareness of risk factors as well as positive effects of group support.
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Telemedicine cardiovascular risk reduction in veterans: The CITIES trial.
Bosworth, HB, Olsen, MK, McCant, F, Stechuchak, KM, Danus, S, Crowley, MJ, Goldstein, KM, Zullig, LL, Oddone, EZ
American heart journal. 2018;:122-129
Abstract
BACKGROUND Comprehensive programs addressing tailored patient self-management and pharmacotherapy may reduce barriers to cardiovascular disease (CVD) risk reduction. METHODS This is a 2-arm (clinical pharmacist specialist-delivered, telehealth intervention and education control) randomized controlled trial including Veterans with poorly controlled hypertension and/or hypercholesterolemia. Primary outcome was Framingham CVD risk score at 6 and 12 months, with systolic blood pressure; diastolic blood pressure; total cholesterol; low-density lipoprotein; high-density lipoprotein; body mass index; and, for those with diabetes, HbA1c as secondary outcomes. RESULTS Among 428 Veterans, 50% were African American, 85% were men, and 33% had limited health literacy. Relative to the education control group, the clinical pharmacist specialist-delivered intervention did not show a reduction in CVD risk score at 6 months (-1.8, 95% CI -3.9 to 0.3; P = .10) or 12 months (-0.3, 95% CI -2.4 to 1.7; P = .74). No differences were seen in systolic blood pressure, diastolic blood pressure, or low-density lipoprotein at 6 or 12 months. We did observe a significant decline in total cholesterol at 6 months (-7.0, 95% CI -13.4 to -0.6; P = .03) in the intervention relative to education control group. Among patients in the intervention group, 34% received at least 5 of the 12 planned intervention calls and were considered "compliers." A sensitivity analysis of the "complier average causal effect" of intervention compared to control showed a mean difference in CVD risk score reduction of 5.7 (95% CI -12.0 to 0.7) at 6 months and -1.7 (95% CI -7.6 to 4.8) at 12 months. CONCLUSIONS Despite increased access to pharmacist resources, we did not observe significant improvements in CVD risk for patients randomized to the intervention compared to education control over 12 months. However, the intervention may have positive impact among those who actively participate, particularly in the short term.