Supporting Parenting at Home-Empowering Rehabilitation through Engagement (SPHERE): study protocol for a randomised control trial.
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ABSTRACT: Introduction
Infants with neurodevelopmental disabilities (NDs) show emotional, cognitive and sociointeractive dysregulation dramatically impacting on caregiving behaviour. Early video-feedback interventions (VFIs) are effective in promoting sensitive parenting, which in turn supports infants' development, even in case of ND. In the light of limited resources of the healthcare systems, technological advances in telemedicine may facilitate the delivery of VFI to a greater number of families of infants with ND. To date, no study has implemented a telemedicine VFI (TVFI) for families of infants diagnosed with ND.Methods and analysis
The Supporting Parenting at Home-Empowering Rehabilitation through Engagement project is a randomised controlled trial aimed at assessing the effectiveness of an early family-centred TVFI parenting support on dyads with infants diagnosed with ND. It includes two arms (TVFI vs Booklet Psychoeducational Intervention) and three assessment phases: T0, baseline; T1, immediate postintervention; T2, 6-month follow-up.Ethics and dissemination
This study is funded by the Italian Ministry of Health and was approved by the Ethics Committee (Pavia). Results will be published in peer-reviewed journals and presented at national and international scientific conferences.Trial registration number
The study protocol has been also registered on NIH Clinical Trials (protocol code NCT04656483; Pre-results).
SUBMITTER: Grumi S
PROVIDER: S-EPMC8672000 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundSupervised cardio-pulmonary rehabilitation may be safe and beneficial for people with pulmonary hypertension (PH) in groups 1 (pulmonary arterial hypertension) and 4 (chronic thromboembolic disease), particularly as a hospital in-patient. It has not been tested in the most common PH groups; 2 (left heart disease), 3 (lung disease), or 5 (other disorders). Further it has not been evaluated in the UK National Health Service (NHS) out-patient setting, or with long-term follow-up. The aim of this randomised controlled trial (RCT) is to test the clinical and cost-effectiveness of a supervised exercise rehabilitation intervention with psychosocial support compared to best practice usual care for people with PH in the community/outpatient setting.MethodsThis multi-centre, pragmatic, two-arm RCT with embedded process evaluation aims to recruit 352 clinically stable adults with PH (groups 1-5) and WHO functional class II-IV. Participants will be randomised to either the Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) intervention or control. The SPHERe intervention consists of 1) individual assessment and familiarisation sessions; 2) 8-week, twice-weekly, supervised out-patient exercise training; 3) psychosocial/motivational support and education; 4) guided home exercise plan. The control intervention consists of best practice usual care with a single one-to-one practitioner appointment, and general advice on physical activity. Outcomes will be measured at baseline, 4 months (post-intervention) and 12 months by researchers blinded to treatment allocation. The primary outcome is the incremental shuttle walk test at 4 months. Secondary outcomes include health-related quality of life (HRQoL), time to clinical worsening and health and social care use. A purposive sample of participants (n = 20 intervention and n = 20 control) and practitioners (n = 20) will be interviewed to explore experiences of the trial, outcomes and interventions.DiscussionThe SPHERe study is the first multi-centre clinical RCT to assess the clinical and cost effectiveness of a supervised exercise rehabilitation intervention compared to usual care, delivered in the UK NHS, for people in all PH groups. Results will inform clinicians and commissioners as to whether or not supervised exercise rehabilitation is effective and should be routinely provided for people with PH.Trial registrationISRCTN no. 10608766, prospectively registered on 18th March 2019.
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Project description:The purpose of this study was to examine the feasibility and usefulness of a universal screening tool, the Family Map Inventory (F MI), to assess family strengths and needs in a home visiting program. The FMI has been used successfully by center-based early childcare programs to tailor services to family need and build on existing strengths. Home visiting coordinators (N = 39) indicated the FMI would provide useful information, and they had the capacity to implement. In total, 70 families who enrolled in a Home Instruction for Parents of Preschool Youngsters (HIPPY) program were screened by the coordinator. The results of the FMI provided meaningful information about the home and parenting environment. Overall, most caregivers provided high levels of school readiness and parental warmth and low levels of family conflict and parenting stress. On the other hand, many families did not provide adequate food quality, exhibited chaotic home environments, and practiced negative discipline. This study demonstrated that the FMI is a feasible and useful option to assess comprehensive family needs in home visiting programs. It also demonstrated that the FMI provided home visiting coordinators a system to measure family strengths and needs. This could provide an assessment of program effectiveness and changes in the family's environment.
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Project description:BACKGROUND:Interventions to improve the nutritional status of older adults and the integration of formal and family care systems are critical research areas to improve the independence and health of aging communities and are particularly relevant in the rehabilitation setting. OBJECTIVE:The primary outcome aimed to determine if the FREER (Family in Rehabilitation: EmpowERing Carers for improved malnutrition outcomes) intervention in malnourished older adults during and postrehabilitation improve nutritional status, physical function, quality of life, service satisfaction, and hospital and aged care admission rates up to 3 months postdischarge, compared with usual care. Secondary outcomes evaluated include family carer burden, carer services satisfaction, and patient and carer experiences. This pilot study will also assess feasibility and intervention fidelity to inform a larger randomized controlled trial. METHODS:This protocol is for a mixed-methods two-arm historically-controlled prospective pilot study intervention. The historical control group has 30 participants, and the pilot intervention group aims to recruit 30 patient-carer pairs. The FREER intervention delivers nutrition counseling during rehabilitation, 3 months of postdischarge telehealth follow-up, and provides supportive resources using a novel model of patient-centered and carer-centered nutrition care. The primary outcome is nutritional status measured by the Scored Patient-Generated Subjective Global Assessment Score. Qualitative outcomes such as experiences and perceptions of value will be measured using semistructured interviews followed by thematic analysis. The process evaluation addresses intervention fidelity and feasibility. RESULTS:Recruitment commenced on July 4, 2018, and is ongoing with eight patient-carer pairs recruited at the time of manuscript submission. CONCLUSIONS:This research will inform a larger randomized controlled trial, with potential for translation to health service policies and new models of dietetic care to support the optimization of nutritional status across a continuum of nutrition care from rehabilitation to home. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry Number (ACTRN) 12618000338268; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374608&isReview=true (Archived by WebCite at http://www.webcitation.org/74gtZplU2). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/12647.
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Project description:BACKGROUND:Anxiety and depression are common among patients attending cardiac rehabilitation services. Currently available pharmacological and psychological interventions have limited effectiveness in this population. There are presently no psychological interventions for anxiety and depression integrated into cardiac rehabilitation services despite emphasis in key UK National Health Service policy. A new treatment, metacognitive therapy, is highly effective at reducing anxiety and depression in mental health settings. The principal aims of the current study are (1) to evaluate the acceptability of delivering metacognitive therapy in a home-based self-help format (Home-MCT) to cardiac rehabilitation patients experiencing anxiety and depressive symptoms and conduct a feasibility trial of Home-MCT plus usual cardiac rehabilitation compared to usual cardiac rehabilitation; and (2) to inform the design and sample size for a full-scale trial. METHODS:The PATHWAY Home-MCT trial is a single-blind feasibility randomised controlled trial comparing usual cardiac rehabilitation (control) versus usual cardiac rehabilitation plus home-based self-help metacognitive therapy (intervention). Economic and qualitative evaluations will be embedded within the trial. Participants will be assessed at baseline and followed-up at 4 and 12 months. Patients who have been referred to cardiac rehabilitation programmes and have a score of ??8 on the anxiety and/or depression subscales of the Hospital Anxiety and Depression Scale will be invited to take part in the study and written informed consent will be obtained. Participants will be recruited from the National Health Service in the UK. A minimum of 108 participants will be randomised to the intervention and control arms in a 1:1 ratio. DISCUSSION:The Home-MCT feasibility randomised controlled trial will provide evidence on the acceptability of delivering metacognitive therapy in a home-based self-help format for cardiac rehabilitation patients experiencing symptoms of anxiety and/or depression and on the feasibility and design of a full-scale trial. In addition, it will provide provisional point estimates, with appropriately wide measures of uncertainty, relating to the effectiveness and cost-effectiveness of the intervention. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03129282 , Submitted to Registry: 11 April 2017.
| S-EPMC6097432 | biostudies-literature
Project description:AimTo investigate the short- and long-term effects of home-based pulmonary rehabilitation (HBPR) on functional capacity, quality of life, peripheral muscle strength, dyspnoea and daily physical activity in people with bronchiectasis.MethodsRandomised controlled trial with 63 participants with bronchiectasis. The HBPR group performed three sessions per week for 8 weeks (aerobic exercise: step training for 20 min; resistance training: exercises for quadriceps, hamstrings, deltoids and biceps brachii using elastic bands). The control group received a recommendation to walk at moderate intensity, three times per week. A weekly phone call was conducted for all participants, and the HBPR group received a home visit every 15 days. The primary outcome was distance in the incremental shuttle walk test (ISWT). Secondary outcomes were time in the endurance shuttle walk test (ESWT), number of steps in the incremental step test, quality of life, quadriceps muscle strength and daily physical activity. Measures were taken before and after intervention and 6 months later.ResultsAfter the intervention, the HBPR group had increased ISWT distance compared with the control group with between-group difference 87.9 m (95% CI 32.4-143.5 m). In addition, between-group differences were found in the ESWT, incremental step test, quality of life and quadriceps muscle strength, favouring the HBPR group. After 6 months, no differences were observed between the groups.ConclusionHBPR is an effective alternative offering of pulmonary rehabilitation for people with bronchiectasis. However, the programme was not effective in maintaining the benefits after 6 months of follow-up.
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Project description:BackgroundProfessional support to enhance the early parent-infant relationship in the first months after birth is recommended, but little is known about the effect of universal interventions. The objective was to investigate the effect of health visitors' use of the Newborn Behavioral Observations system in new families.MethodsA cluster-randomised study was conducted in four Danish municipalities. Health visitors' geographical districts constituted the units for randomisation (n = 17). In the intervention group, 1332 families received NBO from 3 weeks after birth; in the comparison group, 1234 received usual care. Self-administered questionnaires were collected at baseline one to two weeks after birth, and at follow-up three and nine months postpartum. The outcomes were change over time measured by The Karitane Parenting Confidence Scale (KPCS), The Major Depression Inventory (MDI), The Ages and Stages Questionnaire: social-emotional (ASQ:SE) and The Mother and Baby Interaction Scale (MABIC). Data were analysed with mixed-effects linear regression using the intention-to-treat approach.ResultsAt baseline, no significant differences between the two groups were seen regarding maternal and infant factors. At follow-up three and nine months after birth, the change in maternal confidence and mood, infant's socio-emotional behaviour, and early parent-infant relationship moved in a slightly more positive direction in the intervention group than in the comparison group, though not statistically significant. The only significant effect was that the intervention mothers reported higher level of knowledge about infant's communication skills, response to cues, and how to sooth and establish a relation with the infant, compared to the comparison group.ConclusionsWe found no effect of the NBO system delivered in a universal context to all families in a community setting. The only significant difference between groups was a higher maternal degree of knowledge regarding early parenting in the intervention group.Trial registrationClinicalTrials.gov ID: NCT03070652 . Registrated February 22, 2017.
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Project description:'Take Home' Naloxone (THN) kits for use by peers in the event of an opioid overdose may reduce further overdose and deaths, but distribution through Drugs Services may not reach those at highest risk. Attendance by paramedics at emergency calls for patients who have suffered an overdose presents an opportunity to distribute THN kits. In this feasibility study we will assess the acceptability of this intervention, and gather data to inform definitive trial planning.Cluster randomised trial with staggered allocation of paramedics (clusters) to groups. We will invite paramedics in an urban area of south Wales, UK to take part. We will randomly allocate those that accept to training sessions during the first 4 months of the trial. Patients attended by paramedics who have been trained and issued THN kits will fall into the intervention group. Patients attended by paramedics following usual practice (until they receive their training and THN kits) will fall into the control group. We will gather data about processes and outcomes of care: numbers of patients eligible for intervention, offered and accepted THN, attended emergency department, suffered further overdose, died within 3 months and about follow-up rates: numbers of patients consented, completed (postal or telephone) questionnaire. We will gather qualitative data about acceptability to patients and paramedics through interviews and focus groups.Ethical approval for this study was granted on 7 December 2011, by South East Wales Research Ethics Committee, Panel C. Results of this study will be reported through peer-reviewed scientific journals, conference presentations and internal organisational report. We will also seek to report our findings through local and national substance misuse networks and publications.ISRCTN98216498.
| S-EPMC3963087 | biostudies-other
Project description:BackgroundPulmonary rehabilitation is a cornerstone of care for COPD but uptake of traditional centre-based programmes is poor. We assessed whether home-based pulmonary rehabilitation, delivered using minimal resources, had equivalent outcomes to centre-based pulmonary rehabilitation.MethodsA randomised controlled equivalence trial with 12 months follow-up. Participants with stable COPD were randomly assigned to receive 8 weeks of pulmonary rehabilitation by either the standard outpatient centre-based model, or a new home-based model including one home visit and seven once-weekly telephone calls from a physiotherapist. The primary outcome was change in 6 min walk distance (6MWD).ResultsWe enrolled 166 participants to receive centre-based rehabilitation (n=86) or home-based rehabilitation (n=80). Intention-to-treat analysis confirmed non-inferiority of home-based rehabilitation for 6MWD at end-rehabilitation and the confidence interval (CI) did not rule out superiority (mean difference favouring home group 18.6 m, 95% CI -3.3 to 40.7). At 12 months the CI did not exclude inferiority (-5.1 m, -29.2 to 18.9). Between-group differences for dyspnoea-related quality of life did not rule out superiority of home-based rehabilitation at programme completion (1.6 points, -0.3 to 3.5) and groups were equivalent at 12 months (0.05 points, -2.0 to 2.1). The per-protocol analysis showed the same pattern of findings. Neither group maintained postrehabilitation gains at 12 months.ConclusionsThis home-based pulmonary rehabilitation model, delivered with minimal resources, produced short-term clinical outcomes that were equivalent to centre-based pulmonary rehabilitation. Neither model was effective in maintaining gains at 12 months. Home-based pulmonary rehabilitation could be considered for people with COPD who cannot access centre-based pulmonary rehabilitation.Trial registration numberNCT01423227, clinicaltrials.gov.
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Project description:Children displaying psychosocial problems are at an increased risk of negative developmental outcomes. Parenting practices are closely linked with child development and behaviour, and parenting programmes have been recommended in the treatment of child psychosocial problems. However, parental mental health also needs to be addressed when delivering parenting programmes as it is linked with parenting practices, child outcomes, and treatment outcomes of parenting programmes. This paper describes the protocol of a study examining the effects of a combined intervention of a parenting programme and a cognitive behavioural intervention for mental health problems.The effects of a combined intervention of Triple P Discussion Groups and Stress Control will be examined using a randomised controlled trial design. Parents with a child aged 3-8 years will be recruited to take part in the study. After obtaining informed consent and pre-intervention measures, participants will be randomly assigned to either an intervention or a waitlist condition. The two primary outcomes for this study are change in dysfunctional/ineffective parenting practices and change in symptoms of depression, anxiety, and stress. Secondary outcomes are child behaviour problems, parenting experiences, parental self-efficacy, family relationships, and positive parental mental health. Demographic information, participant satisfaction with the intervention, and treatment fidelity data will also be collected. Data will be collected at pre-intervention, mid-intervention, post-intervention, and 3-month follow-up.The aim of this paper is to describe the study protocol of a randomised controlled trial evaluating the effects of a combined intervention of Triple P Discussion Groups and Stress Control in comparison to a waitlist condition. This study is important because it will provide evidence about the effects of this combined intervention for parents with 3-8 year old children. The results of the study could be used to inform policy about parenting support and support for parents with mental health problems.ClinicalTrial.gov: NCT01777724, UTN: U1111-1137-1053.
| S-EPMC3852548 | biostudies-literature
Project description:IntroductionPoverty is a key contributor to delayed diagnosis and limited access to early intervention and rehabilitation for children with cerebral palsy (CP) in rural Bangladesh. 97% of families of children with CP live below the poverty line in Bangladesh. Therefore, in low-and middle-income countries (LMICs), efforts to improve outcomes for children with CP (including health-related quality of life, motor function, communication, and nutritional attainments) should also include measures to improve family economic and social capital. We propose a randomised controlled trial (RCT) to evaluate the effectiveness of an integrated microfinance/livelihood and community-based rehabilitation (IMCBR) program for ultra-poor families of children with CP in rural Bangladesh.Material and methodsThis will be a cluster RCT comparing three arms: (a) integrated microfinance/livelihood and community-based rehabilitation (IMCBR); (b) community-based rehabilitation (CBR) alone; and (c) care-as-usual (i.e. no intervention). Seven clusters will be recruited within each arm. Each cluster will consist of 10 child-caregiver dyads totalling 21 clusters with 210 dyads. Parents recruited in the IMCBR arm will take part in a microfinance/livelihood program and Parent Training Module (PTM), their children with CP will take part in a Goal Directed Training (GDT) program. The programs will be facilitated by specially trained Community Rehabilitation Officers. The CBR arm includes the same PTM and GDT interventions excluding the microfinance/livelihood program. The care-as-usual arm will be provided with information about early intervention and rehabilitation. The assessors will be blinded to group allocation. The duration of the intervention will be 12 months; outcomes will be measured at baseline, 6 months, 12 months, and 18 months.ConclusionThis will be the first RCT of an integrated microfinance/livelihood and CBR program for children with CP in LMIC settings. Evidence from the study could transform approaches to improving wellbeing of children with CP and their ultra-poor families.
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