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Effect of Behaviorally Designed Gamification With Social Incentives on Lifestyle Modification Among Adults With Uncontrolled Diabetes: A Randomized Clinical Trial.
Patel, MS, Small, DS, Harrison, JD, Hilbert, V, Fortunato, MP, Oon, AL, Rareshide, CAL, Volpp, KG
JAMA network open. 2021;(5):e2110255
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Abstract
IMPORTANCE Gamification is increasingly being used to promote healthy behaviors. However, it has not been well tested among patients with chronic conditions and over longer durations. OBJECTIVE To test the effectiveness of behaviorally designed gamification interventions to enhance support, collaboration, or competition to promote physical activity and weight loss among adults with uncontrolled type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS A 4-arm randomized clinical trial with a 1-year intervention was conducted from January 23, 2017, to January 27, 2020, with remotely monitored intervention. Analyses were conducted between February 10 and October 6, 2020. Participants included 361 adults with type 2 diabetes with hemoglobin A1c levels greater than or equal to 8% and body mass index greater than or equal to 25. INTERVENTIONS All participants received a wearable device, smart weight scale, and laboratory testing. Participants in the control group received feedback from their devices but no other interventions. Participants in the gamification arms conducted goal setting and were entered into a 1-year game designed using insights from behavioral economics with points and levels for achieving step goals and weight loss targets. The game varied by trial arm to promote either support, collaboration, or competition. MAIN OUTCOMES AND MEASURES Co-primary outcomes included daily step count, weight, and hemoglobin A1c level. Secondary outcome was low-density lipoprotein cholesterol level. Intention-to-treat analysis was used. RESULTS Participants had a mean (SD) age of 52.5 (10.1) years; hemoglobin A1c level, 9.6% (1.6%); daily steps, 4632 (2523); weight, 107.4 kg (20.8 kg); and body mass index, 37.1 (6.6). Of the 361 participants, 202 (56.0%) were women, 143 (39.6%) were White, and 185 (51.2%) were Black; with 87 (24.1%) randomized to control; 92 (25.4%) randomized to gamification with support and intervention; 95 (26.3%) randomized to gamification with collaboration; and 87 (24.1%) randomized to gamification with competition. Compared with the control group over 1 year, there was a significant increase in mean daily steps from baseline among participants receiving gamification with support (adjusted difference relative to control group, 503 steps; 95% CI, 103 to 903 steps; P = .01) and competition (606 steps; 95% CI, 201 to 1011 steps; P = .003) but not collaboration (280 steps; 95% CI, -115 to 674 steps; P = .16). All trial arms had significant reductions in weight and hemoglobin A1c levels from baseline, but there were no significant differences between any of the intervention arms and the control arm. There was only 1 adverse event reported that may have been related to the trial (arthritic knee pain). CONCLUSIONS AND RELEVANCE Among adults with uncontrolled type 2 diabetes, a behaviorally designed gamification intervention in this randomized clinical trial significantly increased physical activity over a 1-year period when designed to enhance either support or competition but not collaboration. No differences between intervention and control groups were found for other outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02961192.
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Efficacy of a Low-Dose Diosmin Therapy on Improving Symptoms and Quality of Life in Patients with Chronic Venous Disease: Randomized, Double-Blind, Placebo-Controlled Trial.
Serra, R, Ielapi, N, Bitonti, A, Candido, S, Fregola, S, Gallo, A, Loria, A, Muraca, L, Raimondo, L, Velcean, L, et al
Nutrients. 2021;(3)
Abstract
Chronic Venous Disease (CVD) is a common medical condition affecting up to 80% of the general population. Clinical manifestations can range from mild to more severe signs and symptoms that contribute to the impairment of the quality of life (QoL) of affected patients. Among treatment options, venoactive drugs such as diosmin are widely used in the symptomatic treatment in all clinical stages. The aim of this study is to determine the effectiveness of a new formulated diosmin in relieving symptoms and improving QoL in patients suffering from CVD. In this randomized, double-blind, placebo-controlled, multicenter clinical study, CVD patients with a Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system between C2 and C4 were randomized to receive a bioavailable diosmin (as μsmin® Plus) 450 mg tablet once daily or a placebo for 8 weeks. Clinical symptoms and QoL were monitored using the measurement of leg circumference, visual analogue scale (VAS) for pain, Global Index Score (GIS) and Venous Clinical Severity Score (VCSS). A total of 72 subjects completed the study. From week 4, leg edema was significantly decreased in the active group (p < 0.001). An improvement in the VAS score was observed in the active group compared to placebo at the end of treatment (p < 0.05). GIS and VCSS scores were significantly improved in the active group at week 8 (p < 0.001). No treatment related-side effects were recorded. The results of this study showed that the administration of low-dose μsmin® Plus was safe and effective in relieving symptoms and improving QoL in subjects with CVD.
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Adding web-based behavioural support to exercise referral schemes for inactive adults with chronic health conditions: the e-coachER RCT.
Taylor, AH, Taylor, RS, Ingram, WM, Anokye, N, Dean, S, Jolly, K, Mutrie, N, Lambert, J, Yardley, L, Greaves, C, et al
Health technology assessment (Winchester, England). 2020;(63):1-106
Abstract
BACKGROUND There is modest evidence that exercise referral schemes increase physical activity in inactive individuals with chronic health conditions. There is a need to identify additional ways to improve the effects of exercise referral schemes on long-term physical activity. OBJECTIVES To determine if adding the e-coachER intervention to exercise referral schemes is more clinically effective and cost-effective in increasing physical activity after 1 year than usual exercise referral schemes. DESIGN A pragmatic, multicentre, two-arm randomised controlled trial, with a mixed-methods process evaluation and health economic analysis. Participants were allocated in a 1 : 1 ratio to either exercise referral schemes plus e-coachER (intervention) or exercise referral schemes alone (control). SETTING Patients were referred to exercise referral schemes in Plymouth, Birmingham and Glasgow. PARTICIPANTS There were 450 participants aged 16-74 years, with a body mass index of 30-40 kg/m2, with hypertension, prediabetes, type 2 diabetes, lower limb osteoarthritis or a current/recent history of treatment for depression, who were also inactive, contactable via e-mail and internet users. INTERVENTION e-coachER was designed to augment exercise referral schemes. Participants received a pedometer and fridge magnet with physical activity recording sheets, and a user guide to access the web-based support in the form of seven 'steps to health'. e-coachER aimed to build the use of behavioural skills (e.g. self-monitoring) while strengthening favourable beliefs in the importance of physical activity, competence, autonomy in physical activity choices and relatedness. All participants were referred to a standard exercise referral scheme. PRIMARY OUTCOME MEASURE Minutes of moderate and vigorous physical activity in ≥ 10-minute bouts measured by an accelerometer over 1 week at 12 months, worn ≥ 16 hours per day for ≥ 4 days including ≥ 1 weekend day. SECONDARY OUTCOMES Other accelerometer-derived physical activity measures, self-reported physical activity, exercise referral scheme attendance and EuroQol-5 Dimensions, five-level version, and Hospital Anxiety and Depression Scale scores were collected at 4 and 12 months post randomisation. RESULTS Participants had a mean body mass index of 32.6 (standard deviation) 4.4 kg/m2, were referred primarily for weight loss and were mostly confident self-rated information technology users. Primary outcome analysis involving those with usable data showed a weak indicative effect in favour of the intervention group (n = 108) compared with the control group (n = 124); 11.8 weekly minutes of moderate and vigorous physical activity (95% confidence interval -2.1 to 26.0 minutes; p = 0.10). Sixty-four per cent of intervention participants logged on at least once; they gave generally positive feedback on the web-based support. The intervention had no effect on other physical activity outcomes, exercise referral scheme attendance (78% in the control group vs. 75% in the intervention group) or EuroQol-5 Dimensions, five-level version, or Hospital Anxiety and Depression Scale scores, but did enhance a number of process outcomes (i.e. confidence, importance and competence) compared with the control group at 4 months, but not at 12 months. At 12 months, the intervention group incurred an additional mean cost of £439 (95% confidence interval -£182 to £1060) compared with the control group, but generated more quality-adjusted life-years (mean 0.026, 95% confidence interval 0.013 to 0.040), with an incremental cost-effectiveness ratio of an additional £16,885 per quality-adjusted life-year. LIMITATIONS A significant proportion (46%) of participants were not included in the primary analysis because of study withdrawal and insufficient device wear-time, so the results must be interpreted with caution. The regression model fit for the primary outcome was poor because of the considerable proportion of participants [142/243 (58%)] who recorded no instances of ≥ 10-minute bouts of moderate and vigorous physical activity at 12 months post randomisation. FUTURE WORK The design and rigorous evaluation of cost-effective and scalable ways to increase exercise referral scheme uptake and maintenance of moderate and vigorous physical activity are needed among patients with chronic conditions. CONCLUSIONS Adding e-coachER to usual exercise referral schemes had only a weak indicative effect on long-term rigorously defined, objectively assessed moderate and vigorous physical activity. The provision of the e-coachER support package led to an additional cost and has a 63% probability of being cost-effective based on the UK threshold of £30,000 per quality-adjusted life-year. The intervention did improve some process outcomes as specified in our logic model. TRIAL REGISTRATION Current Controlled Trials ISRCTN15644451. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 63. See the NIHR Journals Library website for further project information.
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Effectiveness of embedding a specialist preventive care clinician in a community mental health service in increasing preventive care provision: A randomised controlled trial.
Fehily, CM, Bartlem, KM, Wiggers, JH, Wye, PM, Clancy, RV, Castle, DJ, Wilson, A, Rissel, CE, Wutzke, S, Hodder, RK, et al
The Australian and New Zealand journal of psychiatry. 2020;(6):620-632
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OBJECTIVE Clinical practice guidelines recommend that community mental health services provide preventive care for clients' chronic disease risk behaviours; however, such care is often not routinely provided. This study aimed to assess the effectiveness of offering clients an additional consultation with a specialist clinician embedded within a community mental health service, in increasing client-reported receipt of, and satisfaction with, preventive care. METHOD A randomised controlled trial was undertaken in one Australian community mental health service. Participants (N = 811) were randomised to receive usual care (preventive care in routine consultations; n = 405) or usual care plus the offer of an additional consultation with a specialist preventive care clinician (n = 406). Blinded interviewers assessed at baseline and 1-month follow-up the client-reported receipt of preventive care (assessment, advice and referral) for four key risk behaviours individually (smoking, poor nutrition, alcohol overconsumption and physical inactivity) and all applicable risks combined, acceptance of referrals and satisfaction with preventive care received. RESULTS Analyses indicated significantly greater increases in 12 of the 18 preventive care delivery outcomes in the intervention compared to the usual care condition from baseline to follow-up, including assessment for all risks combined (risk ratio = 4.00; 95% confidence interval = [1.57, 10.22]), advice for all applicable risks combined (risk ratio = 2.40; 95% confidence interval = [1.89, 6.47]) and offer of referral to applicable telephone services combined (risk ratio = 20.13; 95% confidence interval = [2.56, 158.04]). For each component of care, there was a significant intervention effect for at least one of the individual risk behaviours. Participants reported high levels of satisfaction with preventive care received, ranging from 77% (assessment) to 87% (referral), with no significant differences between conditions. CONCLUSION The intervention had a significant effect on the provision of the majority of recommended elements of preventive care. Further research is needed to maximise its impact, including identifying strategies to increase client uptake.
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The Effect of Active Plus, a Computer-Tailored Physical Activity Intervention, on the Physical Activity of Older Adults with Chronic Illness(es)-A Cluster Randomized Controlled Trial.
Volders, E, Bolman, CAW, de Groot, RHM, Verboon, P, Lechner, L
International journal of environmental research and public health. 2020;(7)
Abstract
eHealth interventions aimed at improving physical activity (PA) can reach large populations with few resources and demands on the population as opposed to centre-based interventions. Active Plus is a proven effective computer-tailored PA intervention for the older adult population focusing on PA in daily life. This manuscript describes the effects of the Active Plus intervention (N = 260) on PA of older adults with chronic illnesses (OACI), compared to a waiting list control group (N = 325). It was part of a larger randomized controlled trial (RCT) on the effects of the Active Plus intervention on cognitive functioning. OACI (≥65 years) with at least one chronic illness were allocated to one of the conditions. Intervention group participants received PA advice. Baseline and follow-up measurements were assessed after 6 and 12 months. Intervention effects on objectively measured light PA (LPA) and moderate-to-vigorous PA (MVPA) min/week were analysed with multilevel linear mixed-effects models adjusted for the clustered design. Intervention effects on self-reported MVPA min/week on common types of PA were analysed with two-part generalized linear mixed-effects models adjusted for the clustered design. The dropout rate was 19.1% after 6 months and 25.1% after 12 months. Analyses showed no effects on objectively measured PA. Active Plus increased the likelihood to perform self-reported cycling and gardening at six months and participants who cycled increased their MVPA min/week of cycling. Twelve months after baseline the intervention increased the likelihood to perform self-reported walking and participants who cycled at 12 months increased their MVPA min/week of cycling. Subgroup analyses showed that more vulnerable participants (higher degree of impairment, age or body mass index) benefitted more from the intervention on especially the lower intensity PA outcomes. In conclusion, Active Plus only increased PA behaviour to a limited extent in OACI 6 and 12 months after baseline measurements. The Active Plus intervention may yet be not effective enough by itself in OACI. A blended approach, where this eHealth intervention and face-to-face contact are combined, is advised to improve the effects of Active Plus on PA in this target group.
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The effect of Active Plus, a computer-tailored physical activity intervention, on cognitive functioning of elderly people with chronic illness(es) - study protocol for a randomized controlled trial.
Volders, E, Bolman, CAW, de Groot, RHM, Lechner, L
BMC public health. 2019;(1):1197
Abstract
BACKGROUND Physical activity not only is beneficial to a person's health, but can also have a positive influence on cognitive functioning. However, elderly people with chronic illness(es) often do not meet the physical activity guidelines. Physical activity programs for the elderly exist, but these are often expensive and not easily accessible to the elderly with chronic illness(es). In addition, the beneficial effects of these physical activity programs on cognitive functioning have never been specifically tested in this target group. Hence, this randomized controlled trial aims to test whether Active Plus, a proven effective physical activity intervention, is able to improve the cognitive functioning of elderly people with chronic illness(es) or to slow down cognitive decline. In addition, it studies what kind of activity, intensity, duration and frequency of physical activity most strongly influence cognitive functioning. METHODS A randomized controlled trial is performed, comparing the Active Plus intervention group to a waiting list control group. In total 540 older adults (≥65 years) with at least one chronic illness that limits mobility are recruited from 7 municipalities. Comparable neighborhoods within a municipality are randomly allocated to the intervention or control group. Baseline and follow-up measurements after 6 and 12 months assess cognitive functioning and physical activity behavior, measured both objectively with an accelerometer and subjectively with a self-report questionnaire. Multilevel analyses are conducted to assess effects on cognitive functioning, including analyses on moderation effects for physical activity type, frequency, duration and intensity. DISCUSSION To our knowledge this is the first study to investigate effectiveness of a physical activity program on cognitive functioning in elderly people suffering from a broad range of chronic illnesses. If proven effective Active Plus would be a very cost effective intervention not only to increase physical activity, but also to improve cognitive functioning or slow down cognitive decline. Up till now clear evidence is lacking on the kind of physical activity, intensity, duration and frequency needed to achieve cognitive benefits. By measuring both with accelerometers and self-report questionnaires we hope to gain insight in these processes. TRIAL REGISTRATION Nederlands Trial Register NL6005 ; Date of Registration 21-03-2017.
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[Effect of a Physical activity program on self-esteem in subjects with chronic diseases. 'Pas a Pas' community intervention trial].
Villalobos, F, Vinuesa, A, Pedret, R, Reche, A, Domínguez, E, Arija, V, ,
Atencion primaria. 2019;(4):236-244
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AIM: To evaluate the effectiveness of a 9 months of supervised Physical Activity (PA) Program with sociocultural activities, on self-esteem and its association on the control of chronic diseases in adult primary care users. DESIGN Multicenter, randomized, controlled community intervention. LOCATION 4 Primary care centers in Reus-Tarragona, Spain. PARTICIPANTS 364 subjects, randomized to the Control Group (CG=104) and Intervention Group (IG=260). INTERVENTION Supervised walking program of 120min/week with sociocultural activities once a month. MAIN MEASUREMENTS At baseline and at post-intervention we assessed: PA (IPAQ-S), self-esteem (Rosenberg scale) and cardiovascular indicators: smoking, systolic (SBP) and diastolic (DBP) blood pressure, serum LDL and HDL cholesterol, and serum glucose. Sociodemographic characteristics and diagnostic of chronic diseases are recorded. RESULTS The Program increased the PA in the IG (P=.001), while it decreased in the CG (P=.002), and also the self-esteem in the group of participants (1.28 points, P=.006) and in the groups with diagnoses of hypertension (1.60 points, P=.005), dyslipidemia (1.62 points, P=.012), excess weight (1.24 points, P=.011) or anxiety/depression (1.53 points, P=.045), assessed by multivariate statistical models. The increase in self-esteem during the intervention decreased SBP -0.5mmHg (P=.030) in the hypertension group, regardless of baseline SBP and the effect of the intervention. CONCLUSION The PA program increased the PA and self-esteem in adult primary care users. The increase of self-esteem improved the control of SBP in hypertensive patients.
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Impact of a Translated Disease Self-Management Program on Employee Health and Productivity: Six-Month Findings from a Randomized Controlled Trial.
Smith, ML, Wilson, MG, Robertson, MM, Padilla, HM, Zuercher, H, Vandenberg, R, Corso, P, Lorig, K, Laurent, DD, DeJoy, DM
International journal of environmental research and public health. 2018;(5)
Abstract
Disease management is gaining importance in workplace health promotion given the aging workforce and rising chronic disease prevalence. The Chronic Disease Self-Management Program (CDSMP) is an effective intervention widely offered in diverse community settings; however, adoption remains low in workplace settings. As part of a larger NIH-funded randomized controlled trial, this study examines the effectiveness of a worksite-tailored version of CDSMP (wCDSMP [n = 72]) relative to CDSMP (‘Usual Care’ [n = 109]) to improve health and work performance among employees with one or more chronic conditions. Multiple-group latent-difference score models with sandwich estimators were fitted to identify changes from baseline to 6-month follow-up. Overall, participants were primarily female (87%), non-Hispanic white (62%), and obese (73%). On average, participants were age 48 (range: 23⁻72) and self-reported 3.25 chronic conditions (range: 1⁻16). The most commonly reported conditions were high cholesterol (45%), high blood pressure (45%), anxiety/emotional/mental health condition (26%), and diabetes (25%). Among wCDSMP participants, significant improvements were observed for physically unhealthy days (uΔ = −2.07, p = 0.018), fatigue (uΔ = −2.88, p = 0.002), sedentary behavior (uΔ = −4.49, p = 0.018), soda/sugar beverage consumption (uΔ = −0.78, p = 0.028), and fast food intake (uΔ = −0.76, p = 0.009) from baseline to follow-up. Significant improvements in patient⁻provider communication (uΔ = 0.46, p = 0.031) and mental work limitations (uΔ = −8.89, p = 0.010) were also observed from baseline to follow-up. Relative to Usual Care, wCDSMP participants reported significantly larger improvements in fatigue, physical activity, soda/sugar beverage consumption, and mental work limitations (p < 0.05). The translation of Usual Care (content and format) has potential to improve health among employees with chronic conditions and increase uptake in workplace settings.
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The BETTER WISE protocol: building on existing tools to improve cancer and chronic disease prevention and screening in primary care for wellness of cancer survivors and patients - a cluster randomized controlled trial embedded in a mixed methods design.
Manca, DP, Fernandes, C, Grunfeld, E, Aubrey-Bassler, K, Shea-Budgell, M, Lofters, A, Campbell-Scherer, D, Sopcak, N, O'Brien, MA, Meaney, C, et al
BMC cancer. 2018;(1):927
Abstract
BACKGROUND There is a pressing need to reduce the burden of chronic disease and improve healthcare system sustainability through improved cancer and chronic disease prevention and screening (CCDPS) in primary care. We aim to create an integrated approach that addresses the needs of the general population and the special concerns of cancer survivors. Building on previous research, we will develop, implement, and test the effectiveness of an approach that proactively targets patients to attend an individualized CCDPS intervention delivered by a Prevention Practitioner (PP). The objective is to determine if patients randomized to receive an individualized PP visit (vs standard care) have improved cancer surveillance and CCDPS outcomes. Implementation frameworks will help identify and address facilitators and barriers to the approach and inform future dissemination and uptake. METHODS/DESIGN The BETTER WISE project is a pragmatic two-arm cluster randomized controlled trial embedded in a mixed methods design, including a qualitative evaluation and an economic assessment. The intervention, informed by the expanded chronic care model and previous research, will be refined by engaging researchers, practitioners, policy makers, and patients. The BETTER WISE tool kit includes blended care pathways for cancer survivors (breast, colorectal, prostate) and CCDPS including lifestyle risk factors and screening for poverty. Patients aged 40-65, including both cancer survivors and general population patients, will be randomized at the physician level to an intervention group or to a wait-list control group. Once the intervention is completed, patients randomized to wait-list control will be invited to receive a prevention visit. The main outcome, calculated at 12-months follow-up, will be an individual patient-level summary composite index, defined as the proportion of CCDPS actions achieved relative to those for which the patient was eligible at baseline. A qualitative evaluation will capture information related to program outcome, implementation (facilitators and barriers), and sustainability. An economic assessment will examine the projected cost-benefit impact of investing in the BETTER WISE approach. DISCUSSION This project builds on existing work and engages end users throughout the process to develop, implement, and determine the effectiveness of a multi-faceted intervention that addresses CCDPS and cancer survivorship in primary care settings. TRIAL REGISTRATION ISRCTN21333761 . Registered on December 19, 2016.
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Indexes of the erythropoietin level in the blood plasma of chronic heart failure patients with anemia.
Zahidova, KK
Journal of basic and clinical physiology and pharmacology. 2018;(1):11-17
Abstract
BACKGROUND Anemia aggravates the disease course and the survival rate of chronic heart failure (CHF) patients. The purpose of the study was to investigate the level of erythropoietin (EPO) in CHF patients with anemic syndrome, with the aim to more accurately assess the severity of the disease and its treatment, depending on the anemia degree. METHODS Patients with ischemic CHF of I-IV functional class (FC) with and without anemia were examined (total number of patients=208, patients with anemia=174). The EPO was determined using the enzyme-linked immunosorbent assay. Before treatment, the patients underwent the following medical therapy: angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, long-acting nitrates, diuretics, digoxin, and beta-blockers at individual doses. Depending on the plasma EPO level, the CHF patients with anemia were divided into four randomized groups in terms of treatment. RESULTS Normal erythropoietinemia was found in 36.2% of the CHF patients with anemic syndrome (I-III FC), hypoerythropoietinemia in 44.8% (III-IV FC), and hypererythropoietinemia in 18.96% (III-V FC). The EPO level in the blood plasma of the patients with I-II FC CHF with hypoerythropoietinemia, who were treated with methoxy polyethylene glycol-epoetin β (MEB), increased by 2.2 times. Combination therapy with disease-modifying drugs and MEB led to a significant increase in the plasma EPO level in the CHF patients with hypoerythropoietinemia. CONCLUSIONS It was shown that the EPO level in patients with CHF and anemia did not always drop. Hypererythropoietinemia in patients with CHF and anemia leads to an unfavorable treatment prediction. This necessitates the investigation of the EPO level in all patients with CHF before and after treatment, with the aim of correcting the anemic syndrome. The research showed that the combined therapy of patients with CHF and anemia using MEB medication and iron with regard to the EPO level in the blood plasma improved their overall physical condition, reduced heart failure symptoms and hospitalization frequency, and demonstrated a clear tendency to reduce the general mortality rate.