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Feasibility of a Sleep Self-Management Intervention in Pregnancy Using a Personalized Health Monitoring Device: Protocol for a Pilot Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Sleep disruptions are common during pregnancy and associated with increased risk of adverse maternal outcomes such as preeclampsia, gestational diabetes, prolonged labor, and cesarean birth. Given the morbidity associated with poor sleep, cost-effective approaches to improving sleep that can be disseminated in community or clinical settings are needed. Personal health monitor (PHM) devices offer an opportunity to promote behavior change, but their acceptability and efficacy at improving sleep in pregnant women are unknown. OBJECTIVE:The goal of the paper is to describe the protocol for an ongoing pilot randomized controlled trial that aims to establish the feasibility, acceptability, and preliminary efficacy of using a PHM device (Shine 2, Misfit) to promote sleep during pregnancy. METHODS:The proposed pilot study is a 12-week, parallel arm, randomized controlled trial. Pregnant women, at 24 weeks gestation, will be randomized at a 1:1 ratio to a 12-week sleep education plus PHM device group or a sleep education alone comparison group. The primary outcomes will be measures of feasibility (ie, recruitment, enrollment, adherence) and acceptability (ie, participant satisfaction). The secondary outcomes will be self-reported sleep quality and duration, excessive daytime sleepiness, fatigue, and depressive symptoms. RESULTS:Recruitment for this study began in September 2017 and ended in March 2018. Data collection for the primary and secondary aims was completed in August 2018. We anticipate that the data analysis for primary and secondary aims will be completed by December 2019. The results from this trial will inform the development of a larger National Institutes of Health grant application to test the efficacy of an enhanced version of the sleep intervention that we plan to submit in the year 2020. CONCLUSIONS:This study will be the first to apply a PHM device as a tool for promoting self-management of sleep among pregnant women. PHM devices have the potential to facilitate behavioral interventions because they include theory-driven, self-regulatory techniques such as behavioral self-monitoring. The results of the study will inform the development of a sleep health intervention for pregnant women. TRIAL REGISTRATION:ClinicalTrials.gov NCT03783663; https://clinicaltrials.gov/ct2/show/NCT03783663 (Archived by WebCite at http://www.webcitation.org/779Ou8hon). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/12455.

SUBMITTER: Hawkins M

PROVIDER: S-EPMC6658274 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Feasibility of a Sleep Self-Management Intervention in Pregnancy Using a Personalized Health Monitoring Device: Protocol for a Pilot Randomized Controlled Trial.

Hawkins Marquis M Iradukunda Favorite F Paterno Mary M

JMIR research protocols 20190529 5

<h4>Background</h4>Sleep disruptions are common during pregnancy and associated with increased risk of adverse maternal outcomes such as preeclampsia, gestational diabetes, prolonged labor, and cesarean birth. Given the morbidity associated with poor sleep, cost-effective approaches to improving sleep that can be disseminated in community or clinical settings are needed. Personal health monitor (PHM) devices offer an opportunity to promote behavior change, but their acceptability and efficacy at ...[more]

PMID: 31144670

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Project description:BackgroundTo support effective self-management after kidney transplantation, a holistic nurse-led self-management support intervention was developed using the Intervention Mapping approach. The primary aim was to evaluate the feasibility, acceptability and fidelity of the intervention for kidney transplant recipients and professionals. The secondary aim was to explore preliminary effects on outcomes.MethodsA pilot study was conducted in 2015-2017 to evaluate the intervention. Nurse Practitioners (NP) guided recipients in assessing 14 life areas using the Self-Management Web. Participants were supported in developing self-regulation skills which can be applied to self-management of the illness. Strategies included goal setting, action planning, and promotion of motivation and self-efficacy. Adult recipients from an outpatient clinic of a Dutch University Hospital who underwent their transplant at least 1 month ago, were invited to participate. NPs, nephrologists and recipients were interviewed to assess feasibility, fidelity and implementation experience. Consultations were videoed and analysed to assess fidelity. To assess the preliminary effects, the intervention group completed baseline (T0) and follow-up (T1) questionnaires on self-management behavior, self-efficacy, quality of life and quality of care. A historical control group of kidney transplant recipients completed the same questionnaires at T1.ResultsTwenty-seven recipients agreed to participate in the intervention group, of which 24 completed the intervention and 16 completed baseline and follow-up surveys. The control group consisted of 33 recipients. Professionals and recipients appraised the open, holistic focus of the intervention as a welcome addition to standard care and felt that this helped to build a relationship of trust. Recipients also felt they became more competent in problem-solving skills. The within-group analysis showed no significant increase in patients' self-management skills. The between-groups analysis showed significantly higher medication adherence among the intervention group (P = 0.03; G = 0.81). The within-groups analysis showed a significantly higher perceived quality of care (P = 0.02) in the intervention group.ConclusionThis holistic nurse-led self-management support intervention was found to be feasible and acceptable by professionals and recipients alike. This pilot had a small sample therefore further research is needed into the potential effects on self-management behavior and well-being of transplant recipients. ISRCTN Trial Registry: ISRCTN15057632 (registered retrospectively on 20-07-2018).

Project description:BACKGROUND:The proliferation of wearable devices that collect activity and heart rate data has facilitated new ways to measure sleeping and waking durations unobtrusively and longitudinally. Most existing sleep/wake identification algorithms are based on activity only and are trained on expensive and laboriously annotated polysomnography (PSG). Heart rate can also be reflective of sleep/wake transitions, which has motivated its investigation herein in an unsupervised algorithm. Moreover, it is necessary to develop a personalized approach to deal with interindividual variance in sleep/wake patterns. OBJECTIVE:We aimed to develop an unsupervised personalized sleep/wake identification algorithm using multifaceted data to explore the benefits of incorporating both heart rate and activity level in these types of algorithms and to compare this approach's output with that of an existing commercial wearable device's algorithms. METHODS:In this study, a total of 14 community-dwelling older adults wore wearable devices (Fitbit Alta; Fitbit Inc) 24 hours a day and 7 days a week over period of 3 months during which their heart rate and activity data were collected. After preprocessing the data, a model was developed to distinguish sleep/wake states based on each individual's data. We proposed the use of hidden Markov models and compared different modeling schemes. With the best model selected, sleep/wake patterns were characterized by estimated parameters in hidden Markov models, and sleep/wake states were identified. RESULTS:When applying our proposed algorithm on a daily basis, we found there were significant differences in estimated parameters between weekday models and weekend models for some participants. CONCLUSIONS:Our unsupervised approach can be effectively implemented based on an individual's multifaceted sleep-related data from a commercial wearable device. A personalized model is shown to be necessary given the interindividual variability in estimated parameters.

Project description:Pregnant individuals rarely achieve moderate-to-vigorous intensity physical activity recommendations.Purpose The sedentary behavior reduction in pregnancy intervention (SPRING) pilot and feasibility randomized trial aimed to demonstrate feasibility, acceptability, and initial efficacy of a lower intensity intervention targeting reduced sedentary behavior and increased standing and steps.Methods First trimester pregnant individuals at risk for high sedentary behavior and adverse pregnancy outcomes (APO) were randomized 2:1 to a multi-component sedentary behavior reduction intervention or no-contact control. Intervention components included biweekly remote health coaching, wearable activity monitor, height-adjustable workstation, and a private Facebook group. Evidence-based behavioral targets included sedentary time < 9 h/day, increasing standing by 2-3 h/day, and ≥ 7500 steps/day. Participants completed all-remote assessments (baseline, second trimester, third trimester) of sedentary behavior and activity (thigh-worn activPAL) along with exploratory pregnancy health outcomes abstracted from medical records. Intervention effects vs. control were evaluated using generalized mixed models and an intention-to-treat approach. Intervention participants also provided feedback on perceived benefits and acceptability.Results Participants (34 intervention; 17 control) had mean age 32 years, were 83% White, with mean pre-pregnancy BMI 28 kg/m2. Retention was high (90% and 83% at second and third trimester follow-up visits). Intervention participants decreased sedentary time (-0.84 h/day, p = 0.019) and increased standing (+0.77 h/day, p = 0.003), but did not increase steps/day (+710, p = 0.257) compared to controls. Intervention participants reported many perceived benefits and identified the wearable, height-adjustable workstation, and behavioral lessons as most useful.Conclusion For pregnant individuals at risk for high sedentary behavior and APOs, a sedentary behavior reduction intervention is feasible, acceptable, and may offer a viable alternative to more intense physical activity recommendations during pregnancy. Further testing in a fully powered clinical trial is warranted.Trial registration NCT05093842 on clinicaltrials.gov.

Project description:BackgroundRaised blood pressure (BP) affects approximately 10% of pregnancies worldwide, and a high proportion of affected women develop pre-eclampsia. This study aimed to evaluate the feasibility of self-monitoring of BP in pregnancy in women at higher risk of pre-eclampsia.MethodsThis prospective cohort study of self-monitoring BP in pregnancy was carried out in two hospital trusts in Birmingham and Oxford and thirteen primary care practices in Oxfordshire. Eligible women were those defined by the UK National Institute for Health and Care Excellence (NICE) guidelines as at higher risk of pre-eclampsia. A total of 201 participants were recruited between 12 and 16 weeks of pregnancy and were asked to take two BP readings twice daily three times a week through their pregnancy. Primary outcomes were recruitment, retention and persistence of self-monitoring. Study recruitment and retention were analysed with descriptive statistics. Survival analysis was used to evaluate the persistence of self-monitoring and the performance of self-monitoring in the early detection of gestational hypertension, compared to clinic BP monitoring. Secondary outcomes were the mean clinic and self-monitored BP readings and the performance of self-monitoring in the detection of gestational hypertension and pre-eclampsia compared to clinic BP.ResultsOf 201 women recruited, 161 (80%) remained in the study at 36 weeks or to the end of their pregnancy, 162 (81%) provided any home readings suitable for analysis, 148 (74%) continued to self-monitor at 20 weeks and 107 (66%) at 36 weeks. Self-monitored readings were similar in value to contemporaneous matched clinic readings for both systolic and diastolic BP. Of the 23 who developed gestational hypertension or pre-eclampsia and self-monitored, 9 (39%) had a raised home BP prior to a raised clinic BP.ConclusionsSelf-monitoring of BP in pregnancy is feasible and has potential to be useful in the early detection of gestational hypertensive disorders but maintaining self-monitoring throughout pregnancy requires support and probably enhanced training.

Project description:Financial incentives could be used to improve adherence to behavioral weight loss interventions, increasing their effectiveness. This Phase IIb randomized pilot study evaluated the feasibility and acceptability of a study protocol for providing financial incentives for dietary self-monitoring and/or weight loss. Community-dwelling adults with obesity were enrolled in a 24 week, group-based weight loss program. Participants were randomized in a 2 × 2 factorial design to receive financial incentives for both dietary self-monitoring and weekly weight loss, just one, or neither. Participants could earn up to $300, evolving from fixed weekly payments to intermittent, variable payments. The notice of reward was provided by text message. The study was conducted in three successive cohorts to evaluate study procedure changes, including dietary approach, recruitment and retention strategies, text messaging, and incentives. Descriptive statistics calculated separately for each cohort described study performance relative to predefined targets for recruitment, including minority representation; retention; adherence; and weight loss. Acceptability was assessed via postintervention qualitative interviews. In Cohort 1 (n = 34), a low-carbohydrate diet was used. Recruitment, retention, adherence, and weight loss were adequate, but minority representation was not. For Cohort 2 (n = 31), employing an additional recruitment method and switching to a reduced-calorie diet yielded adequate recruitment, minority representation, retention, and adherence but less weight loss. Returning to a low-carbohydrate diet in Cohort 3 (n = 28) yielded recruitment, minority representation, retention, adherence, and weight loss similar to Cohort 2. Participant feedback informed changes to text message timing and content and incentive amount. Through successive cohorts, we optimized recruitment and retention strategies and text messaging. An adequately powered trial is warranted to evaluate the efficacy of these incentive structures for reducing weight. The trial registration number is NCT02691260.

Project description:ObjectiveTo evaluate the feasibility of implementing a self-management intervention to improve mobility in the community for stroke survivors.MethodsA two-phase sequential mixed methods design was used (a pilot randomised controlled trial and focus groups). Participants were adult stroke survivors within six months post discharge from hospital with functional and cognitive capacity for self-management. The intervention included education sessions, goal setting and action planning, group sessions, self-monitoring and follow up. The control group received usual care and both groups enrolled for 3 months in the study. Feasibility outcomes (recruitment and retention rates, randomisation and blinding, adherence to the intervention, collection of outcome measures, and the fidelity and acceptability of the intervention). Participants assessed at baseline, 3 months and 6 months for functional mobility and walking, self-efficacy, goal attainment, cognitive ability, and general health. A descriptive analysis was done for quantitative data and content analysis for the qualitative data. Findings of quantitative and qualitative data were integrated to present the final results of the study.ResultsTwenty-four participants were recruited and randomised into two groups (12 each). It was feasible to recruit from hospital and community and to deliver the intervention remotely. Randomisation and blinding were successful. Participants were retained (83%) at 3 months and (79.2%) at 6 months assessments. Adherence to the intervention varied due to multiple factors. Focus groups discussed participants' motivations for joining the programme, their perspectives on the intervention (fidelity and acceptability) and methodology, perceived improvements in mobility, facilitators and challenges for self-management, and suggestions for improvement.ConclusionThe self-management intervention seems feasible for implementation for stroke survivors in the community. Participants appreciated the support provided and perceived improvement in their mobility. The study was not powered enough to draw a conclusion about the efficacy of the program and a future full-scale study is warranted.

Dataset Information

Feasibility of a Sleep Self-Management Intervention in Pregnancy Using a Personalized Health Monitoring Device: Protocol for a Pilot Randomized Controlled Trial.

Publications

Feasibility of a Sleep Self-Management Intervention in Pregnancy Using a Personalized Health Monitoring Device: Protocol for a Pilot Randomized Controlled Trial.

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