Faculty Opinions recommendation of Weight monitoring in patients with severe heart failure (WISH). A randomized controlled trial.

Peritoneal ultrafiltration (PuF) has been employed for severe heart failure (HF), but evidence for its benefit is lacking. The Peritoneal Dialysis for Heart Failure (PDHF) study was a multicenter prospective randomized controlled trial which aimed to investigate this issue. The trial stopped early due to inadequate recruitment. We describe methods, trial activity, and lessons learned. The trial aimed to recruit 130 participants with severe diuretic-resistant HF (New York Heart Association [NYHA] 3/4) and chronic kidney disease (CKD) stage 3/4 on optimal medical treatment for ≥ 4 weeks from 6 UK centers. Participants were randomized to either continuation of conventional HF treatment or to additionally receiving PuF (1 overnight exchange using Icodextrin dialysate). Primary outcome was change in 6-minute walk test (6MWT) between baseline and 28 weeks (end of trial). Secondary outcomes were changes in patient reported quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire, short form 36 (SF 36) health survey results, hospitalization, and mortality. Over a 2-year period, 290 patients were screened from which only 20 met inclusion criteria and 10 were recruited. Reasons for ineligibility were fluctuating estimated glomerular filtration rate (eGFR), suboptimal HF treatment, frailty, and patients being too unwell for randomization. Barriers to recruitment included patient frailty, with some participants considered only when they were at end of life, unwillingness to engage in an invasive therapy, and suboptimal coordination between cardiology and renal services. This is a challenging patient group in which to perform research, and lessons learned from the peritoneal dialysis (PD)-HF trial will be helpful in the planning of future studies in this area.

Download Full-text

Sensor-controlled digital game and heart failure self-management behaviors: A feasibility randomized controlled trial study (Preprint)

10.2196/preprints.29044 ◽

2021 ◽

Author(s):

Kavita Radhakrishnan ◽

Christine Julien ◽

Thomas Baranowski ◽

Matthew O'Hair ◽

Grace Lee ◽

...

Keyword(s):

Physical Activity ◽

Heart Failure ◽

Older Adults ◽

Randomized Controlled Trial ◽

Functional Status ◽

Controlled Trial ◽

Intervention Group ◽

Self Management ◽

Randomized Controlled ◽

Weight Monitoring

BACKGROUND Poor self-management of heart failure (HF) contributes to devastating health consequences. Our innovative sensor-controlled digital game (SCDG) integrates data from sensors to trigger game rewards, progress, and feedback based on HF individuals’ real-time behaviors. OBJECTIVE To compare daily weight-monitoring and physical activity behavior adherence by older adults using a SCDG intervention versus a sensor-only intervention, in a feasibility randomized controlled trial. METHODS English-speaking HF adults aged ≥55 years who owned a smartphone and could walk unassisted were recruited from Texas and Oklahoma from November 2019 to August 2020. Both groups were given activity tracker and smart weight scale sensors to track behaviors for 12 weeks. Feasibility outcomes of recruitment, retention, intervention engagement, and satisfaction were assessed. Besides daily weight-monitoring and physical activity adherence, participants’ knowledge, functional status, quality of life (QoL), self-reported HF behaviors, motivation to engage in behaviors, and HF-related hospitalization were also compared between the groups at baseline, 6, 12, and 24 weeks. RESULTS Participants (N=38; intervention n=19; control n=19) with HF were enrolled (47% female, 47% ≥65 years, 55% HF hospitalization in past 6 months, 76% White); 82% of patients (n=31; intervention, 15/19, 79%; control, 16/19, 84%) had both weight monitoring and physical activity data at the end of 12 weeks and 71% (n =27; intervention, 14/19, 74%; control, 13/19, 68%) participated in follow-up assessments at 24 weeks. For the intervention group participants who installed the SCDG app (n=15), the number of days each player opened the game app was strongly associated with the number of days the player engaged in weight-monitoring (r=0.72, P=0.04) and with the number of days with physical activity step data (r=0.9, P < 0.001). Participants who completed the satisfaction survey (intervention, n=13) reported that the SCDG was easy to use. Trends of improvement in daily weight-monitoring and physical activity in the intervention group and within-group improvements in HF functional status, QoL, knowledge, self-efficacy, and HF hospitalization in both groups were observed in this feasibility trial. CONCLUSIONS Playing an SCDG on smartphones was feasible and acceptable for older adults with HF for motivating daily weight monitoring and physical activity. A larger efficacy trial of the SCDG intervention will be needed to validate trends of improvement in daily weight monitoring and physical activity behaviors. CLINICALTRIAL Clinicaltrials.gov NCT03947983; https://clinicaltrials.gov/ct2/show/NCT03947983

Download Full-text