The helping older people engage (HOPE) study: Protocol & COVID modifications for a randomized trial.

Objectives: Evidence-based strategies to reduce loneliness in later life are needed because loneliness impacts all domains of health, functioning, and quality of life. Volunteering is a promising strategy, as a large literature of observational studies documents associations between volunteering and better health and well-being. However, relatively few studies have used randomized controlled trials (RCTs) to examine benefits of volunteering, and none have examined loneliness. The primary objective of the Helping Older People Engage (HOPE) study is to examine the social-emotional benefits of a social volunteering program for lonely older adults. This manuscript describes the rationale and design of the trial. Methods: We are randomly assigning adults aged 60 or older (up to 300) who report loneliness to 12 months of either AmeriCorps Seniors volunteering program or an active control (self-guided life review). Co-primary outcomes are assessed via self-report-loneliness (UCLA Loneliness Scale) and quality of life (WHOQOL-Bref). Enrollment was completed in May 2022 and follow-up assessments will continue through May 2023, with completion of primary outcomes soon thereafter. Conclusions: Since older adults who report loneliness are less likely to actively seek out volunteering opportunities, if results support efficacy of volunteering for reducing loneliness, dissemination and scaling up efforts may involve connecting primary care patients who are lonely with AmeriCorps Seniors through aging services agencies.This RCT is registered at clinicaltrials.gov (NCT03343483).

Cost-effectiveness of cardiac resynchronization therapy in the MADIT-CRT trial.

BACKGROUND: The Multicenter Automatic Defibrillator Implantation Trial-Cardiac Resynchronization Therapy (MADIT-CRT) trial demonstrated that cardiac resynchronization therapy (CRT) when added to the implantable cardiac defibrillator (ICD) reduces risk of heart failure or death in minimally symptomatic patients with reduced cardiac ejection fraction and wide QRS complex. OBJECTIVES: To evaluate 4-year cost-effectiveness of CRT-ICD compared to ICD alone using MADIT-CRT data. RESEARCH DESIGN: Patients enrolled in the trial were randomized to implantation of either ICD or CRT-ICD in a 2:3 ratio, with up to 4-year follow-up period. Cost-effectiveness analyses were conducted, and sensitivity analyses by age, gender, and left bundle branch block (LBBB) conduction pattern were performed. SUBJECTS: A total of 1,271 patients with ICD or CRT-ICD (US centers only) who reported healthcare utilization and health-related quality of life data. MEASURES: We used the EQ-5D (US weights) to assess patient HRQOL and translated utilization data to costs using national Medicare reimbursement rates. RESULTS: Average 4-year healthcare expenditures in CRT-ICD patients were higher than costs of ICD patients ($62,600 vs 57,050, P = 0.015), mainly due to the device and implant-related costs. The incremental cost-effectiveness ratio of CRT-ICD compared to ICD was $58,330/quality-adjusted life years (QALY) saved. The cost effectiveness improved with longer time horizon and for the LBBB subgroup ($7,320/QALY), with no cost-effectiveness benefit being evident in the non-LBBB group. CONCLUSIONS: In minimally symptomatic patients with low ejection fraction and LBBB, CRT-ICD is cost effective within 4-year horizon when compared to ICD-only.

Cardiac resynchronization and quality of life in patients with minimally symptomatic heart failure.

OBJECTIVES: This study compared the quality of life (QOL) of patients with cardiac resynchronization therapy (CRT) and an implantable cardioverter-defibrillator (ICD) to patients with an ICD only. BACKGROUND: CRT with ICD is associated with a reduction in heart failure risk among minimally symptomatic patients. It is unknown whether this improves QOL. METHODS: This study uses the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) data. The MADIT-CRT enrolled 1,820 patients at 110 centers across 14 countries. Patients had ischemic cardiomyopathy (New York Heart Association [NYHA] functional class I or II) or nonischemic cardiomyopathy (NYHA functional class II only), sinus rhythm, an ejection fraction of 30% or less, and prolonged intraventricular conduction with a QRS duration of 130 ms or more. QOL was evaluated on the 1,699 patients with baseline and follow-up measures using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Six dimensions (Physical Limitation, Symptom Stability, Symptom Frequency, Symptom Burden, Quality of Life, and Social Limitations) and 3 summary scores (Total Symptom, Clinical Summary, and Overall Summary) were analyzed. RESULTS: During an average follow-up of 2.4 years, the CRT-ICD group had greater improvement than the ICD-only group on all KCCQ measures (p < 0.05 on each scale). These differences were significant among patients with left bundle branch block conduction disturbance (n = 1,204, p < 0.01 on each scale), but not among patients without left bundle branch block (n = 494). CONCLUSIONS: Compared with patients with ICD only, CRT-ICD is associated with greater improvement in QOL among relatively asymptomatic patients, specifically among those with left bundle branch conduction disturbance.