The rapid development of a novel kidney-specific digital intervention for self-management of physical activity and emotional well-being during the COVID-19 pandemic and beyond: Kidney Beam.
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ABSTRACT:
SUBMITTER: Mayes J
PROVIDER: S-EPMC8690269 | biostudies-literature | 2022 Mar
REPOSITORIES: biostudies-literature
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The rapid development of a novel kidney-specific digital intervention for self-management of physical activity and emotional well-being during the COVID-19 pandemic and beyond: Kidney Beam.
Mayes Juliet J Billany Roseanne E RE Vadaszy Noemi N Young Hannah M L HML Castle Ellen M EM Bishop Nicolette C NC Bramham Kate K Nixon Andrew C AC Wilkinson Thomas J TJ Hamilton Alexander J AJ Saynor Zoe L ZL Chilcot Joseph J Picariello Federica F Macdonald Jamie J Greenwood Sharlene A SA
Clinical kidney journal 20211204 3
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Project description:This trial assessed the feasibility and acceptability of Kidney BEAM, a physical activity and emotional well-being self-management digital health intervention (DHI) for people with chronic kidney disease (CKD), which offers live and on-demand physical activity sessions, educational blogs and videos, and peer support. In this mixed-methods, multicentre randomised waitlist-controlled internal pilot, adults with established CKD were recruited from five NHS hospitals and randomised 1:1 to Kidney BEAM or waitlist control. Feasibility outcomes were based upon a priori progression criteria. Acceptability was primarily explored via individual semi-structured interviews (n = 15). Of 763 individuals screened, n = 519 (68%, 95% CI 65 to 71%) were eligible. Of those eligible, n = 303 (58%, 95% CI 54-63%) did not respond to an invitation to participate by the end of the pilot period. Of the 216 responders, 50 (23%, 95% CI 18-29%) consented. Of the 42 randomised, n = 22 (10 (45%) male; 49 ± 16 years; 14 (64%) White British) were allocated to Kidney BEAM and n = 20 (12 (55%) male; 56 ± 11 years; 15 (68%) White British) to the waitlist control group. Overall, n = 15 (30%, 95% CI 18-45%) withdrew during the pilot phase. Participants completed a median of 14 (IQR 5-21) sessions. At baseline, 90-100% of outcome data (patient reported outcome measures and a remotely conducted physical function test) were completed and 62-83% completed at 12 weeks follow-up. Interview data revealed that remote trial procedures were acceptable. Participants' reported that Kidney BEAM increased their opportunity and motivation to be physically active, however, lack of time remained an ongoing barrier to engagement with the DHI. An randomised controlled trial of Kidney BEAM is feasible and acceptable, with adaptations to increase recruitment, retention and engagement.Trial registration NCT04872933. Date of first registration 05/05/2021.
| S-EPMC10771473 | biostudies-literature
Project description:BackgroundPhysical activity and emotional self-management has the potential to enhance health-related quality of life (HRQoL), but few people with chronic kidney disease (CKD) have access to resources and support. The Kidney BEAM trial aims to evaluate whether an evidence-based physical activity and emotional wellbeing self-management programme (Kidney BEAM) leads to improvements in HRQoL in people with CKD.MethodsThis was a prospective, multicentre, randomised waitlist-controlled trial, with health economic analysis and nested qualitative studies. In total, three hundred and four adults with established CKD were recruited from 11 UK kidney units. Participants were randomly assigned to the intervention (Kidney BEAM) or a wait list control group (1:1). The primary outcome was the between-group difference in Kidney Disease Quality of Life (KDQoL) mental component summary score (MCS) at 12 weeks. Secondary outcomes included the KDQoL physical component summary score, kidney-specific scores, fatigue, life participation, depression and anxiety, physical function, clinical chemistry, healthcare utilisation and harms. All outcomes were measured at baseline and 12 weeks, with long-term HRQoL and adherence also collected at six months follow-up. A nested qualitative study explored experience and impact of using Kidney BEAM.Results340 participants were randomised to Kidney BEAM (n = 173) and waiting list (n = 167) groups. There were 96 (55%) and 89 (53%) males in the intervention and waiting list groups respectively, and the mean (SD) age was 53 (14) years in both groups. Ethnicity, body mass, CKD stage, and history of diabetes and hypertension were comparable across groups. The mean (SD) of the MCS was similar in both groups, 44.7 (10.8) and 45.9 (10.6) in the intervention and waiting list groups respectively.ConclusionResults from this trial will establish whether the Kidney BEAM self management programme is a cost-effective method of enhancing mental and physical wellbeing of people with CKD.Trial registrationNCT04872933. Registered 5th May 2021.
| S-EPMC10152439 | biostudies-literature
Project description:BackgroundIn people living with polycystic kidney disease (PKD), physical inactivity may contribute to poor health-related quality of life (HRQoL). To date, no research has elucidated the impact of a PKD-specific physical activity programme on HRQoL and physical health. This substudy of the Kidney BEAM Trial evaluated the impact of a PKD-specific 12-week educational and physical activity digital health intervention for people living with PKD.MethodsThis study was a mixed-methods, single-blind, randomized waitlist-controlled trial. Sixty adults with a diagnosis of PKD were randomized 1:1 to the intervention or a waitlist control group. Primary outcome was difference in the Kidney Disease QoL Short Form 1.3 Mental Component Summary (KDQoL-SF1.3 MCS) between baseline and 12 weeks. Six participants completed individualized semi-structured interviews.ResultsAll 60 individuals (mean 53 years, 37% male) were included in the intention-to-treat analysis. At 12 weeks, there was a significant difference in mean adjusted change in KDQoL MCS score between the intervention group and waitlist control [4.2 (95% confidence interval 1.0-7.4) arbitrary units, P = .012]. Significant between-group differences in KDQoL subscales-burden of kidney disease (P = .034), emotional wellbeing (P = .001) and energy/fatigue (P = .001)-were also achieved. There was no significant between-group difference in KDQoL PCS scores (P = .505). Per-protocol analyses revealed significant between group differences in the PAM-13 patient activation score (P = .010) and body mass (P = .027). Mixed-methods analyses revealed key influences of the programme, including opportunities for peer support and to build on new skills and knowledge, as well as the empowerment and self-management.ConclusionA PKD-specific digital health educational and physical activity intervention is acceptable and has the potential to improve HRQoL. Further research is needed to better understand how specific education and lifestyle management may help to support self-management behaviour.
| S-EPMC11892433 | biostudies-literature
Project description:AimCancer remains a disease with a significant impact on morbidity and mortality but also on quality of life. This prospective randomized pilot study investigated the effects of a sound intervention on physical and emotional well-being in outpatients with cancer.MethodsTwo self-applied sound interventions were used for this purpose, either active "music playing" with a body monochord or passive sound intervention with headphones to listen to a given music compilation. Interventions were carried out over a period of 4 weeks for at least 15 min in the evening before bedtime. The following self-assessment questionnaires were completed both at baseline and after 4 weeks to evaluate the response: the Pittsburgh Sleep Quality Index (PSQI), the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), Visual Analogue Scale (VAS) for pain and fatigue, and the Fear of Progression (FoP) questionnaire. Primary endpoint of this exploratory trial was to describe the rate of patients with improvement in at least one dimension without worsening of any other.Results73 patients (29 male, 44 female) were included in the study and randomized to either active (n = 34, 47%) or passive sound intervention (n = 39, 53%). Median age was 52.0 years (range 21-79). Fourteen patients (19%) stated that they were musically active. The sound intervention was carried out on a median of 26 days (range 5-28). A higher percentage of patients in the passive group reached the primary endpoint: n = 15 (39%) versus n = 9 (27%). Response differences in favour of the passive group were seen with the VAS fatigue and with QLQ-30 questionnaires. Overall, an improvement in QLQ-30 questionnaire was seen in 12 patients (31%) in the passive group versus 3 patients (9%). Moreover, sound intervention significantly improved social functioning and shortness of breath in the passive group according to QLQ-C30. Significant improvements were also noticed in the passive group in terms of affective reactions as a domain of the FoP questionnaire. No effects on pain or sleep quality could be observed.ConclusionA 4-week self-administered sound intervention was feasible in outpatients suffering from cancer. Using a panel of 5 questionnaires, passive sound interventions appeared to be more likely to positively influence patient-reported outcomes. In particular, a positive impact was documented in social functioning and fatigue.
| S-EPMC10015753 | biostudies-literature
Project description:Following kidney donation, short-term quality of life outcomes compare favorably to US normative data but long-term effects on mood are not known. In the Renal and Lung Living Donors Evaluation Study (RELIVE), records from donations performed 1963-2005 were reviewed for depression and antidepressant use predonation. Postdonation, in a cross-sectional cohort design 2010-2012, donors completed the Patient Health Questionnaire (PHQ-9) depression screening instrument, the Life Orientation Test-Revised, 36-Item Short Form Health Survey and donation experience questions. Of 6909 eligible donors, 3470 were contacted and 2455 participated (71%). The percent with depressive symptoms (8%; PHQ-9>10) was similar to National Health and Nutrition Examination Survey participants (7%, p=0.30). Predonation psychiatric disorders were more common in unrelated than related donors (p=0.05). Postdonation predictors of depressive symptoms included nonwhite race OR=2.00, p=0.020), younger age at donation (OR=1.33 per 10 years, p=0.002), longer recovery time from donation (OR=1.74, p=0.0009), greater financial burden (OR=1.32, p=0.013) and feeling morally obligated to donate (OR=1.23, p=0.003). While cross-sectional prevalence of depression is comparable to population normative data, some factors identifiable around time of donation, including longer recovery, financial stressors, younger age and moral obligation to donate may identify donors more likely to develop future depression, providing an opportunity for intervention.
| S-EPMC4205186 | biostudies-literature
Project description:IntroductionThere is inequity in the provision of physical rehabilitation services for people living with chronic kidney disease (CKD). The Kidney BEAM trial evaluated the clinical value and cost effectiveness of a physical activity digital health intervention (DHI) in CKD.MethodsIn a single-blind, 11 center, randomized controlled trial, 340 adult participants with CKD were randomly assigned to either the Kidney BEAM physical activity DHI or a waitlist control. This study assessed the difference in the Kidney Disease Quality of Life Short Form 1.3 Mental Component Summary (KDQoL-SF1.3 MCS) between intervention and control groups at 6-months, and cost-effectiveness of the intervention.ResultsAt 6-months, there was a significant difference in mean adjusted change in KDQoL MCS score between Kidney BEAM and waitlist control (intention-to-treat adjusted mean: 5.9 [95% confidence interval, CI: 4.4-7.5] arbitrary units [AU], P < 0.0001), and a 93% and 98% chance of the intervention being cost-effective at a willingness-to-pay threshold of £20,000 and £30,000 per quality-adjusted life year gained.ConclusionThe Kidney BEAM physical activity DHI is a clinically valuable and cost-effective means to improve mental health-related quality of life (HRQoL) in people with CKD (trial registration no. NCT04872933).
| S-EPMC11551101 | biostudies-literature
Project description:BackgroundPsychological distress in the early postpartum period can have long-lasting deleterious effects on a mother's well-being and negatively affect her infant's development. Intervention approaches based in contemplative practices such as mindfulness and loving-kindness and compassion are intended to alleviate distress and cultivate well-being and can be delivered effectively as digital mental health interventions (DMHIs).ObjectiveTo understand the feasibility of engaging perinatal women in digital interventions, this study aimed to document participants' experiences in the Mums Minds Matter (MMM) study, a pilot randomized controlled trial comparing mindfulness, loving-kindness and compassion, and progressive muscle relaxation training delivered in a digital format and undertaken during pregnancy. To assess the different stages of engagement during and after the intervention, we adapted the connect, attend, participate, enact (CAPE) framework that is based on the idea that individuals go through different stages of engagement before they are able to enact change.MethodsThe MMM study was nested within a longitudinal birth cohort, The ORIGINS Project. We aimed to recruit 25 participants per randomization arm. Data were collected sequentially during the intervention through regular web-based surveys over 8 weeks, with opportunities to provide regular feedback. In the postintervention phase, qualitative data were collected through purposive sampling.ResultsOf 310 eligible women, 84 (27.1% [connect rate]) enrolled to participate in MMM. Of the remaining 226 women who did not proceed to randomization, 223 (98.7%) failed to complete the baseline surveys and timed out of eligibility (after 30 weeks' gestation), and 3 (1.3%) displayed high psychological distress scores. Across all program groups, 17 (20% [attend rate]) of the 84 participants actively opted out, although more may have disengaged from the intervention but did not withdraw. The main reasons for withdrawal were busy life and other priorities. In this study, we assessed active engagement and ongoing skills use (participate and enact) through postintervention interviews. We undertook 15 participant interviews, conducted 1 month to 3 months after the intervention. Our results provide insights into participant barriers and enablers as well as app changes, such as the ability to choose topics, daily reminders, case studies, and diversity in sounds. Implementing a DMHI that is brief, includes frequent prompts or nudges, and is easily accessible is a key strategy to target perinatal women.ConclusionsOur research will enable future app designs that are sufficiently nuanced to maximize the uptake, engagement, and application of mental health skills and contemplative practices in the perinatal period. Providing convenient access to engaging and effective prevention programs is critical and should be part of prenatal self-care. Our research underscores the appeal and feasibility of digital intervention approaches based in contemplative practices for perinatal women.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) 12620000672954p; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000672954p.International registered report identifier (irrid)RR2-10.2196/19803.
| S-EPMC10618893 | biostudies-literature
Project description:IntroductionThe Kidney BEAM randomized controlled trial reported clinically meaningful and statistically significant improvements in mental health-related quality of life (HRQoL), physical function (sit-to-stand-60, but not the physical component of HRQoL) and patient activation after a 12-week physical activity digital health intervention (DHI). This study explores factors that contributed to the effectiveness of Kidney BEAM through mixed methods analyses.MethodsQuantitative data analysis was obtained from the recently published primary manuscript. Participants from the Kidney BEAM trial intervention group (n = 30) completed individualized semistructured interviews after the 12-week DHI. Interviews were analyzed using the framework method with inductive and deductive coding. Quantitative and qualitative data collection and analyses occurred concurrently, and independently, before combining using a mixed methods analysis with joint displays to triangulate datasets and further explore the primary findings.ResultsThe integrated mixed methods analyses facilitated explanation of the primary findings. The Kidney BEAM intervention was shown to have mental and physical wellbeing benefits and enhanced self-management in this cohort of people living with chronic kidney disease (CKD). Elements that contributed to the effectiveness of the intervention were reported, including the different functional levels and gradual progression of the program, shared lived experiences with other participants, self-monitoring, the sense of achievement, taking back control of their health, moving beyond medications, and feeling safe and confident to exercise.ConclusionElements of the Kidney BEAM intervention that contributed to the main quantitative trial findings were identified. This will allow researchers and practitioners to maximize the effectiveness of DHIs to enhance healthy behaviors in people living with CKD.
| S-EPMC11652097 | biostudies-literature
Project description:Pregnancy involves various physiological, physical, and social changes that can impact the mental health of the woman, causing her to have a stressful experience. Physical fitness (PF) is postulated as a powerful marker of health in this population. Therefore, this longitudinal study examined the association of PF with maternal emotional well-being and ill-being outcomes at 16th and 34th gestational weeks (g.w.) in a sample of 158 pregnant women (32.9 ± 4.7 years old). Self-reported PF was assessed with the valid and feasible International Fitness Scale [i.e., overall PF, cardiorespiratory fitness (CRF), muscular strength, speed-agility, and flexibility]; positive and negative affect, emotional intelligence, and resilience were measured using validated questionnaires specifically designed for this purpose. The results showed that women with greater overall PF and its components showed higher positive affect and lower negative affect (all, p < 0.05); greater emotional intelligence (all, p < 0.05); and greater resilience (all, p < 0.05), with similar results both in the 16th and the 34th g.w. These findings underscore the pivotal role of PF in promoting emotional health and resilience during pregnancy, thereby highlighting the need for integrating PF enhancement strategies in prenatal care programs.
| S-EPMC11395653 | biostudies-literature
Project description:BACKGROUND:Chronic conditions account for 75% of health care costs, and the impact of chronic illness is expected to grow over time. Although subjective well-being predicts better health outcomes, people with chronic conditions tend to report lower well-being. Improving well-being might mitigate costs associated with chronic illness; however, existing interventions can be difficult to access and draw from a single theoretical approach. Happify, a digital well-being intervention program drawing from multiple theoretical traditions to target well-being, has already been established as an efficacious means of improving well-being in both distressed and nondistressed users. OBJECTIVE:This study aimed to compare change in well-being over time after using Happify for users with and without a chronic condition. METHODS:Data were obtained from Happify users, a publicly available digital well-being program accessible via website or mobile phone app. Users work on tracks addressing a specific issue (eg, conquering negative thoughts) composed of games and activities based on positive psychology, cognitive behavioral therapy, and mindfulness principles. The sample included 821 users receiving at least 6 weeks' exposure to Happify (ranging from 42 to 179 days) who met other inclusion criteria. As part of a baseline questionnaire, respondents reported demographic information (age and gender) and whether they had any of the prespecified chronic conditions: arthritis, diabetes, insomnia, multiple sclerosis, chronic pain, psoriasis, eczema, or some other condition (450 reported a chronic condition, whereas 371 did not). Subjective well-being was assessed with the Happify Scale, a 9-item measure of positive emotionality and life satisfaction. To evaluate changes in well-being over time, a mixed effects linear regression model was fit for subjective well-being, controlling for demographics and platform usage. RESULTS:At baseline, users with a chronic condition had significantly lower subjective well-being (mean 38.34, SD 17.40) than users without a chronic condition (mean 43.65, SD 19.13). However, change trajectories for users with or without a chronic condition were not significantly different; both groups experienced equivalent improvements in well-being. We also found an effect for time from baseline (b=0.071; SE=0.010; P<.01) and number of activities completed (b=0.03; SE=0.009; P<.01), and a 2-way interaction between number of activities completed and time from baseline (b=0.0002; SE=0.00006; P<.01), such that completing more activities and doing so over increasingly longer periods produced improved well-being scores. CONCLUSIONS:Data from this study support the conclusion that users with a chronic condition experienced significant improvement over time. Despite reporting lower subjective well-being on the whole, their change trajectory while using Happify was equivalent to those without a chronic condition. Consistent with past research, users who completed more activities over a longer period showed the most improvement. In short, the presence of a chronic condition did not prevent users from showing improved well-being when using Happify.
| S-EPMC6996718 | biostudies-literature