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Caregivers clinical trials

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NCT ID: NCT04556591 Completed - Caregivers Clinical Trials

Mobile Technology and Data Analytics to Identify Real-time Predictors of Caregiver Well-Being

Start date: November 5, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to test whether personalized messages from an easy-to-use mobile app improve mood and stress among care partners and to see if care partners like using the app.

NCT ID: NCT04491110 Completed - Sleep Clinical Trials

Intervention to Improve Quality of Sleep of Palliative Patient Carers in the Community: Clinical Trial

IMECA
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Introduction Sleeping problems experienced by cancer patients carers are frequent with 72% of carers reporting moderate to severe problems. Another consequence for this carers is the increase of suffering from depression and it is usually associated to carer overload. Objectives Main objective: - To evaluate the effects of listening to music in sleep quality for oncology patients non-professional carers at home, and to evaluate the influence of specific factors that may modify that effect. Secondary objectives: - To assess the relationship between the waking state and the consequences during the day according to sleep characteristics. These include: 1. Psychological results: 1. Quality of life. 2. Carer overload. 2. Physical results: 1. Sleepiness during the day. 2. Physical activity, intensity and length evaluation. - To assess carers satisfaction with the intervention. Method Randomized clinical trial, single blinding and performed in oncological patients carers in several practices. 2 samples of 40 carers. Intervention group will be taken through a seven session intervention with music; control group will undergo seven sessions of therapeutic education (as a reminder). Results will be evaluated using Pittsburgh Quality of Sleep Index, triaxial accelerometer, EuroQol-5D-5L, Caregiver Strain Index, Epworth Sleepiness Scale and Client Satisfaction Questionnaire. Statistical analysis Basal values will be compared for both groups. Then the values before and after the intervention will be compared using Student's t distribution for normal continuous variables, and Wilcoxon's T test for paired data in continuous not normal variables. A multiple linear regression will be carried out. The system developed for the PREDIMEDPLUS study will be used to process accelerometer data results. This semi-automated system manages data capture in a continuous stream in a central server of Malaga University. Processing and analysis of this data is also centralised, with an open source package, GGIR v. 1.5-1248

NCT ID: NCT04442399 Completed - HIV Clinical Trials

Family Connection: Pilot of Family-based Self-management for HIV-infected Adolescents

Start date: April 2016
Phase: N/A
Study type: Interventional

The study design has two phases. The first phase is the refinement of intervention manual for an adolescent living with HIV (ALHIV)and their caregiver intervention, followed by a second phase feasibility pilot study. The study goals are to refine and pilot a feasible intervention that fosters resiliency and draws upon the strengths of adolescents and their families. Specific aims include to: (1) Refine activities and an intervention manual for a family-focused group intervention for adolescents and their caregivers to improve HIV self-management among adolescents living with HIV; (2) conduct a pilot study to assess the acceptability and feasibility of the group intervention among 50 adolescent/caregiver pairs that are randomly assigned to the intervention or the comparison arms, and (sub aim 2a) examine preliminary trends in outcome measures, including Anti-Retroviral Therapy (ART) adherence, safer sex behaviors and stigma, comparing the intervention and comparison study arms.

NCT ID: NCT04416529 Completed - Mindfulness Clinical Trials

Tele-Mindfulness for Dementia's Family Caregivers: a Randomized Trial With a Usual Care Control Group

Start date: October 5, 2016
Phase: N/A
Study type: Interventional

Family caregivers were recruited through a combinations of strategies including a larger caregiving project and its partners, memory clinics, community outreach, online advertisement, flyers and brochures and word of mouth. After the telephone screening, eligible individuals were scheduled for an in-person baseline meeting at which they received additional information about the study, signed a consent form, completed baseline outcome measures and then were randomized to the intervention or control group using an online randomization program (http://www.graphpad.com/quickcalcs/index.cfm). All participants completed outcome measures immediately post-intervention for the intervention group and at 2 months for the control group and all participants completed follow-up outcome measures at 3 month following the baseline assessment. Participants in the intervention group completed a practice log which was designed to track their daily practice of mindfulness at home. The study was reviewed and approved by the Mount Sinai Hospital Research Ethics Board.

NCT ID: NCT04386655 Completed - Clinical trials for Traumatic Brain Injury

Brain Injury Coping Skills - Telemedicine: Phase II

BICS-T-2
Start date: March 28, 2019
Phase: N/A
Study type: Interventional

For phase II, the objective is to compare the effectiveness of BICS-T with the well-established BICS in-person group. Information gained from phase I (the feasibility study) was used to make necessary changes to the BICS-T protocol. The purpose of this study is to provide survivors of brain injury and caregivers greater support and teach adaptive coping strategies, through a designed and studied a coping skills group specifically for brain injury survivors and their caregivers at the Rehabilitation Hospital of Indiana (RHI) called the Brain Injury Coping Skills group (BICS).

NCT ID: NCT04376944 Recruiting - COVID-19 Clinical Trials

Barrier Measures to Limit Covid-19.Nosocomial Transmission: a Cross-sectional Evaluation

EMBELLIE
Start date: April 1, 2020
Phase:
Study type: Observational

Use lay language. The Covid-19 pandemic hit France in March 2020 and stage 3 of the epidemic justified the introduction of national and unprecedented containment measures from March 17, 2020. The Montpellier CHU experienced peak hospitalizations of Covid-19 infections in late March. The estimate of the proportion of infected people in Occitania, South of France, for the 11th of May 2020 is 3.1% (95% CI: 1.9-5.9) for the Occitania region, to which Montpellier belongs. In the context of the Covid-19 epidemic, notably due to the absence of pharmacological or vaccine prophylaxis, barrier measures were of crucial importance, especially for exposed caregivers. These measures include an adaptation of individual behavior, the creation of a so-called "Covid" hospital, the wearing of specific equipment in all departments, the use in the rooms of Covid-19 patients of a gown, an apron, gloves, and a FFP2 type mask in the event of contact and sampling, protocolized and standardized bio-cleaning measures, a reorganization of the premises and the definition of specific circuits. In view of the second wave of the epidemic, estimating the effectiveness of the barrier measures is of major importance. The investigators therefore propose an evaluation of the effectiveness of these measures, by comparing the serological prevalence of infection among caregivers working directly in COVID units compared to caregivers working in services excluding the management of Covid-19 patients. Systematic evaluation in COVID-19 units of Sarc-Co-V2 infection will also be assessed, with naso-pharyngeal swabs.

NCT ID: NCT04280861 Recruiting - Quality of Life Clinical Trials

Multicomponent Intervention in Caregivers on Quality of Life of People With Dementia: a Clinical Trial

Start date: February 2, 2020
Phase: N/A
Study type: Interventional

The main objective is to determine the effectiveness of a multicomponent intervention for caregivers, conducted by an expert psychologist to improve the quality of life of the people with Alzheimer's disease. Secondarily, will be analyzed the effectiveness of this program on improving anxiety and depressive symptoms, burden, happiness, social support and cognitive performance of the caregivers and alleviate the behavioural and psychological symptoms of dementia (BPSD). The investigators analyze the caregiver's and patient's personality as a possible moderator between dependent and independent variables, and the resources utilization before and after intervention. Methods: randomized study with parallel assignment in two groups: control and intervention group, six-month follow-up. The eligible participants will be 94 adult (≥18 years) caregivers of patients with Alzheimer's disease who follow-up by Osona Integrated Geriatric Unite (Catalonia, Spain). The intervention group will receive a multicomponent intervention that includes dementia psychoeducation and management, emotional and communication skills, mindfulness and healthy lifestyle. The control group will follow the standard management according to the primary and specialized care professionals' team. Main measurements: quality of life of the patients at baseline, after intervention and at six-month follow-up through QoL-AD. Secondary measures: they will be determined, at baseline, after the intervention and at six-month follow-up: depression (HDRS) and anxiety (HARS), burden (CBI), happiness (OHQ), quality of life (QoL-AD), social support (UCLA and DUKE-ANC), cognitive performance (neuropsychological assessment) of the caregivers, resources utilization (RUD), BPSD (NPI), cognitive status (MMSE), functional status (IADL) of the patients. Caregiver's personality at baseline and six-month follow-up and dementia characteristics at baseline will be measured. Other measures: sociodemographic and health characteristics of the caregivers and patients.

NCT ID: NCT04205396 Completed - Caregivers Clinical Trials

CAREGIVER: A Trial to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis

Start date: February 10, 2020
Phase: N/A
Study type: Interventional

The goal of this study is to enroll caretakers of patients with decompensated cirrhosis to determine if written emotional disclosure or resilience training interventions reduce distress and burden among primary informal caregivers. Caretakers that meet eligibility will complete baseline assessments in person, or if necessary, over the phone and be randomized to be in one of three arms of this study. Materials specific to each study arm will be mailed to the caretakers home along with instructions. Overall, the study will take approximately 2 months and a qualitative interview will also be completed around 3-6 months post-baseline.

NCT ID: NCT04184037 Terminated - Clinical trials for Mild Cognitive Impairment

iMeditate at Home for Older Adults With Mild Cognitive Impairment and Caregivers

Start date: November 15, 2019
Phase: N/A
Study type: Interventional

Individuals diagnosed with mild cognitive impairment (MCI) are at a high risk of developing dementia and are an important target population for interventions that may reduce the risk of cognitive decline. A diagnosis of MCI or dementia also has an important impact on caregivers, who show increased levels of stress, anxiety, and depression. Mindfulness meditation is a promising behavioural intervention that may have important benefits both for older adults with MCI and for caregivers. Previous research suggests that meditation may improve psychological wellbeing, reduce stress, and even improve cognitive function. Technology-based mindfulness meditation platforms may be a much-needed solution for promoting the adoption of mindfulness in these populations. The current study is a pilot randomized control trial of a mindfulness meditation intervention delivered via the Muse platform in two study populations: a) older adults diagnosed with MCI, and b) family caregivers of persons with MCI or neurodegenerative disorders. Muse is a mobile application for meditation that provides real-time feedback about the user's state of mindfulness during meditation via a headband containing electroencephalographic sensors (EEG) that the user wears while meditating. It is thought that this neurofeedback can promote learning and lead to faster improvements in meditation ability and, consequently, greater benefits from meditation practice. This aim of this pilot study is to establish the acceptability of the Muse platform as an intervention in the two study populations, to determine the feasibility of the randomized control trial designed to evaluate the effectiveness of a 6 week intervention with the Muse platform, and to evaluate the effect of neurofeedback on meditation. Participants will be randomly allocated to meditation with neurofeedback (NFB) or meditation without neurofeedback (no-NFB) and will complete daily meditation sessions for 6 weeks. An assessment visit before and after the intervention will evaluate participants' psychological well-being using questionnaires; their visual working memory, attention, and visual perception using behavioural tests; and their mindfulness ability using questionnaires and a behavioural measure. EEG will also be recorded using the Muse headband to examine changes in electrophysiological markers during cognitive tests and at rest.

NCT ID: NCT04114864 Completed - Clinical trials for Mental Health Wellness 1

A Primary Prevention Intervention for the Promotion of Psycho-social Wellbeing in Adolescent Young Carers:

ME-WE
Start date: October 20, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Adolescent young carers (AYCs) are young people aged 15-17 years old, who take on significant or substantial caring tasks and assume a level of responsibility that would usually be associated with an adult. In Europe, the estimated prevalence rate of YCs is around 4-8%.Taking on care responsibilities so early in life may have considerable negative consequences for YCs' mental and physical health and psychosocial development. Psychosocial interventions to support YC worldwide are generally quite limited. The H2020 Me-We project (Psychosocial Support for Promoting Mental Health and Well-being among Adolescent Young Carers in Europe) aims to develop an innovative framework of primary prevention interventions for adolescent YCs (AYCs) aged 15-17 to be tested in six European countries (Italy, Netherlands, Slovenia, Sweden, Switzerland, United Kingdom). The theoretical framework chosen for the intervention is the DNA-V Model. The DNA-V model is a psychological intervention, addressed to adolescents and young people, used in educational and clinical settings. This model has its roots in the contextual and functional science and it is based on Acceptance and Commitment Therapy, a third-generation cognitive-behavioural therapy. The intervention programme designed for the ME-WE project builds on the DNA-V model but it was adapted to fit the specific needs of adolescent young carers (AYCs) and the goals of the ME-WE project. The study aim is to evaluate the efficacy of DNA-V based program for AYCs (so-called ME-WE intervention), using a cluster-randomized controlled trial (C-RCT) design. The evaluation of the intervention will be carried out using as primary outcome variables: Psychological flexibility; Mindfulness skills; Resilience; Subjective mental health; Quality of life; Subjective health complaints; Caring-related quality of life; Cognitive and emotional impact of caring and Social support. As secondary outcome variables will be included Self-reported school, training or work experience, performance, and attendance. COVID-19 Amendment: Recruitment, should be moved to a cluster- based online recruitment or individual, social media recruitment, face-to-face sessions should be moved to online sessions using video-conferencing instruments, allowing for visual presentations of participants and session materials (e.g. ZOOM, Microsoft Teams). Four open-ended items were added to evaluation questionnaire assessing impact of COVID-19 pandemic.