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Effectiveness and cost-effectiveness of a self-management group program to improve social participation in patients with neuromuscular disease and chronic fatigue: protocol of the Energetic study.

ABSTRACT: Chronic fatigue is present in more than 60% of the patients with a neuromuscular disease and can be their most disabling symptom. In combination with other impairments, fatigue often results in low levels of physical activity and decreased social participation, leading to high societal costs. 'Energetic' is a self-management group program aimed at improving social participation, physical endurance and alleviating fatigue in these patients. The primary aim of this study is to evaluate the effectiveness and cost-effectiveness of the Energetic program.A multicentered, assessor-blinded, two-armed randomized controlled trial is conducted with evaluations at inclusion and four, seven and fifteen months later. The study includes patients with a neuromuscular disease and chronic fatigue and, when present, their caregivers. The participants are randomized (ratio 1:1) to either an intervention group, receiving the Energetic program, or a control group, receiving usual care (i.e., no specific intervention). The Energetic program covers four months and includes four modules: 1) individually tailored aerobic exercise training; 2) education about aerobic exercise; 3) self-management training in applying energy conservation strategies; and 4) implementation and relapse prevention in daily life. Two months after cessation of the program a booster session is provided. The primary outcome is the perceived performance score of the Canadian Occupational Performance Measure (COPM). Secondary outcomes include the COPM-satisfaction score, and measures of fatigue, physical endurance, activity engagement, mood, and self-efficacy. Caregiver burden is also evaluated as a secondary outcome. Health-related quality of life and medical and societal costs are assessed to estimate cost-effectiveness of the program.The Energetic study is the first randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a combined physical and self-management group training program for improving social participation, physical endurance and alleviating fatigue in patients with neuromuscular diseases. It will generate new insights in (cost-)effective rehabilitation strategies for these incurable conditions.Clinicaltrials.gov NCT02208687 .

SUBMITTER: Veenhuizen Y

PROVIDER: S-EPMC4411708 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Effectiveness and cost-effectiveness of a self-management group program to improve social participation in patients with neuromuscular disease and chronic fatigue: protocol of the Energetic study.

Veenhuizen Yvonne Y Cup Edith H C EH Groothuis Jan T JT Hendriks Jan C M JC Adang Eddy M M EM van Engelen Baziel G M BG Geurts Alexander C H AC

BMC neurology 20150419

<h4>Background</h4>Chronic fatigue is present in more than 60% of the patients with a neuromuscular disease and can be their most disabling symptom. In combination with other impairments, fatigue often results in low levels of physical activity and decreased social participation, leading to high societal costs. 'Energetic' is a self-management group program aimed at improving social participation, physical endurance and alleviating fatigue in these patients. The primary aim of this study is to e ...[more]

PMID: 25913823

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Project description:IntroductionLess than half of all U.S. adults meet the 2008 Physical Activity Guidelines. Leader behaviors and group cohesion have been associated with increased participation or adherence in sports team and exercise class settings. Physical activity interventions in community settings that encompass these factors may enhance intervention adherence. The purpose of this study is to examine the impact of Community Health Promoter leader behaviors and group cohesion on participation in a walking group intervention among racially/ethnically diverse adults in low to moderate-income communities in Detroit, Michigan.DesignData for the current study were drawn from the Walk Your Heart to Health (WYHH) data set. WYHH was a multisite cluster RCT with a lagged intervention and outcome measurements at baseline and 4, 8, and 32 weeks. Pooled survey data from both intervention arms were used for the current study. Data were analyzed between August 2013 and October 2014.Setting/participantsA total of 603 non-Hispanic black, non-Hispanic white, and Hispanic adults across five cohorts that began the 32-week WYHH intervention between March 2009 and October 2011.InterventionThe intervention was a 32-week walking group program hosted by community- and faith-based organizations and facilitated by Community Health Promoters. Walking groups met three times per week for 90 minutes per session. To promote participation in or adherence to WYHH, Community Health Promoters used evidence-based strategies to facilitate group cohesion. Group members assumed increasing leadership responsibility for facilitating sessions over time.Main outcome measuresParticipation in WYHH as measured by consistency of attendance.ResultsCommunity Health Promoter leader behaviors were positively associated with participation in WYHH. Social but not task cohesion was significantly associated with consistent participation. Social cohesion may mediate the relationship between leader behaviors and walking group participation.ConclusionsProviding leaders with training to build socially cohesive groups may help motivate individuals to continue participation in community-based physical activity programs.

Project description:BackgroundFatigue and its negative impact on life participation are top research priorities of people on chronic dialysis therapy. Energy management education (EME) is a fatigue management approach that teaches people to use practical strategies (eg, prioritizing, using efficient body postures, organizing home environments) to manage their energy expenditure during everyday life.ObjectiveThe aim of this study is to explore whether EME is associated with improvements in fatigue and life participation in adults on chronic dialysis.DesignFive single-case interrupted time-series AB studies, and follow-up qualitative interviews.SettingThe hemodialysis and peritoneal dialysis units at an academic hospital in Toronto, Canada.PatientsIn total, 5 patients on chronic dialysis therapy were purposively selected to represent diversity in age, gender, and modality.MeasurementsBrief questionnaires assessing fatigue and life participation were administered weekly during the baseline and intervention periods. Additional validated questionnaires (the Fatigue Impact Scale, 36-Item Short-Form Health Survey [SF-36] Vitality Scale, and Canadian Occupational Performance Measure) were also administered at baseline and post-intervention.MethodsAll participants underwent "The PEP Program," a personalized, web-supported EME program designed to meet the needs of people on dialysis. During the program, participants complete 2 brief web modules about energy management, and then use energy management principles and a problem-solving framework to work on 3 life participation goals during sessions with a trained program administrator. Data were analyzed using visual analysis and the Tau-U statistic for the weekly time-series data, and thematic analysis for the qualitative interviews.ResultsThree of 5 participants displayed a consistently positive response to the Personal Energy Planning (PEP) program across multiple measures of fatigue and life participation. Tau-U effect size estimates ranged from small to moderate, according to the time-series data. All 5 participants expressed that the program had benefited them in qualitative follow-up interviews, with the most common reported benefit being that the program made day-to-day activities easier. The format of the program was also said to be feasible and convenient.LimitationsAn exploratory, proof-of-concept study that used a small set of participants and lacked an active control comparison.ConclusionsThe PEP program might have potential for improving fatigue-related outcomes in people on chronic dialysis. Larger, controlled studies of the program are warranted.

Project description:ImportanceScreening for breast, cervical, and colorectal cancers in the United States has remained below the Healthy People 2020 goals, with evidence indicating that persistent screening disparities still exist. The US Department of Health and Human Services has emphasized cross-sectoral collaboration in aligning social determinants of health with public health and medical services. Examining the economics of intervening through these novel methods in the realm of cancer screening can inform program planners, health care providers, implementers, and policy makers.ObjectiveTo conduct a systematic review of economic evaluations of interventions leveraging social determinants of health to improve screening for breast, cervical, and colorectal cancer to guide implementation.Evidence reviewA systematic literature search for economic evidence was performed in MEDLINE, Embase, PsycINFO, Cochrane Library, Global Health, Scopus, Academic Search Complete, Business Source Complete, EconLit, CINAHL (Cumulative Index to Nursing and Allied Health Literature), ERIC (Education Resources Information Center), and Sociological Abstracts from January 1, 2004, to November 25, 2019. Included studies intervened on social determinants of health to improve breast, cervical, and colorectal cancer screening in the United States and reported intervention cost, incremental cost per additional person screened, and/or incremental cost per quality-adjusted life-year (QALY). Risk of bias was assessed along with qualitative assessment of quality to ensure complete reporting of economic measures, data sources, and analytic methods. In addition, included studies with modeled outcomes had to define structural elements and sources for input parameters, distinguish between programmatic and literature-derived data, and assess uncertainty.FindingsThirty unique articles with 94 706 real and 4.21 million simulated participants satisfied our inclusion criteria and were included in the analysis. The median intervention cost per participant was $123.87 (interquartile interval [IQI], $24.44-$313.19; 34 estimates). The median incremental cost per additional person screened was $250.37 (IQI, $44.67-$609.38; 17 estimates). Studies that modeled final economic outcomes had a median incremental cost per person of $122.96 (IQI, $46.96-$124.80; 5 estimates), a median incremental screening rate of 15% (IQI, 14%-20%; 5 estimates), and a median incremental QALY per person of 0.04 years (IQI, 0.006-0.06 year; 5 estimates). The median incremental cost per QALY gained of $3120.00 (IQI, $782.59-$33 600.00; 5 estimates) was lower than $50 000, an established, conservative threshold of cost-effectiveness.Conclusions and relevanceInterventions focused on social determinants of health to improve breast, cervical, and colorectal cancer screening appear to be cost-effective for underserved, vulnerable populations in the United States. The increased screening rates were associated with earlier diagnosis and treatment and in improved health outcomes with significant gains in QALYs. These findings represent the latest economic evidence to guide implementation of these interventions, which serve the dual purpose of enhancing health equity and economic efficiency.

Project description:IntroductionProject CLIQ (Community Link to Quit) was a proactive population-outreach strategy using an electronic health records-based smoker registry and interactive voice recognition technology to connect low- to moderate-income smokers with cessation counseling, medications, and social services. A randomized trial demonstrated that the program increased cessation. We evaluated the cost-effectiveness of CLIQ from a provider organization's perspective if implemented outside the trial framework.MethodsWe calculated the cost, cost per smoker, incremental cost per additional quit, and, secondarily, incremental cost per additional life year saved of the CLIQ system compared to usual care using data from a 2011-2013 randomized trial assessing the effectiveness of the CLIQ system. Sensitivity analyses considered economies of scale and initial versus ongoing costs.ResultsOver a 20-month period (the duration of the trial) the program cost US $283 027 (95% confidence interval [CI] $209 824-$389 072) more than usual care in a population of 8544 registry-identified smokers, 707 of whom participated in the program. The cost per smoker was $33 (95% CI 28-40), incremental cost per additional quit was $4137 (95% CI $2671-$8460), and incremental cost per additional life year saved was $7301 (95% CI $4545-$15 400). One-time costs constituted 28% of costs over 20 months. Ongoing costs were dominated by personnel costs (71% of ongoing costs). Sensitivity analyses showed sharp gains in cost-effectiveness as the number of identified smokers increased because of the large initial costs.ConclusionsThe CLIQ system has favorable cost-effectiveness compared to other smoking cessation interventions. Cost-effectiveness will be greatest for health systems with high numbers of smokers and with the high smoker participation rates.ImplicationsHealth information systems capable of establishing registries of patients who are smokers are becoming more prevalent. This economic analysis illustrates the cost implications for health care systems adopting a proactive tobacco treatment outreach strategy for low- and middle-income smokers. We find that under many circumstances, the CLIQ system has a favorable cost-per-quit compared to other population-based tobacco treatment strategies. The strategy could be widely disseminable if health systems leverage economies of scale.

Dataset Information

Effectiveness and cost-effectiveness of a self-management group program to improve social participation in patients with neuromuscular disease and chronic fatigue: protocol of the Energetic study.

Publications

Effectiveness and cost-effectiveness of a self-management group program to improve social participation in patients with neuromuscular disease and chronic fatigue: protocol of the Energetic study.

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