- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07615205
Strength for Caregiving
Strength for Caregiving - A Nutrition Coaching Model to Support Caregivers' Wellbeing and Functional Ability
The goal of this single-arm pre-post study is to promote elderly (≥ 65 years) family caregivers' dietary habits, well-being and functional capacity through comprehensive nutritional guidance. The main goals of the project are to:
- Improve the well-being, resilience, and functional capacity of the participating family caregivers through the comprehensive nutritional counseling implemented as part of the project.
- Create a nutrition counseling model that promotes the well-being and coping of family caregivers and can also be utilized in well-being services counties after the project concludes.
- Produce up-to-date and practical nutrition materials for family caregivers.
The project participants will participate in two individual nutrition counselling sessions and three group nutrition counseling sessions over a period of ten months.
Researchers will compare the results of the participants' baseline and final measurements to see if nutrition counseling is effective in improving family caregivers' well-being, resilience, and functional capacity.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Background: A large proportion of Finnish family caregivers are older adults. Serving as a family caregiver places both psychological and physical strain on the caregiver. As a result, taking care of one's own well-being may be overlooked. Previous studies have shown that up to 40% of family caregivers may be at risk of malnutrition. Inadequate nutrition weakens family caregivers' health and functional capacity, potentially threatening their ability to continue providing care. At present, there is no structured and clearly defined approach to systematically addressing the nutritional status and nutritional needs of family caregivers as part of family caregivers services. Consequently, family caregivers may not receive easily accessible, targeted, and reliable nutritional guidance or materials, even though nutrition is an important factor in maintaining health, functional capacity and the ability to continue caregiving.
Aims: The aim of the Strength for Caregiving project is to promote elderly (≥ 65 years) family caregivers' dietary habits, well-being, and functional capacity through comprehensive nutritional counseling. In addition, the project aims to develop and pilot a nutritional counseling model targeted at family caregivers. The project will also produce nutrition materials for family caregivers.
Methods: The study examines the effectiveness of a 10-month tailored nutritional counseling intervention on well-being, functional capacity, nutritional status and dietary habits among elderly caregivers living in the Satakunta region, Finland. The planned sample size is 100 participants.
The 10-month intervention includes two individual counseling sessions and three group counseling sessions. The individual sessions are conducted by a nutritionist and include a personal nutrition plan. Based on the participants' preferences, the group sessions consist of either nutrition lectures or practical cooking courses.
Study outcomes are assessed at baseline and after 10 months. Outcomes are measured using questionnaires and three-day food records. Nutritional status, weight, blood pressure and muscle strength are measured at the same time points during appointments with research nurse.
Expected outcomes: The project is expected to improve family caregivers' dietary habits, well-being, and functional capacity. The nutrition coaching model will include individual and group counseling, practical cooking courses, and materials for implementing these activities, enabling different organizations and professionals to use the model and continue providing counseling after the project has ended. The materials produced will be publicly available and widely usable after the project.
Discussion: The study will support family caregivers' ability to continue their caregiving role and help reduce nutrition-related health risks. Integrating the nutrition counseling model into family caregiver services in the well-being services county will lay the foundation for long-term change. Openly available materials may help ensure that the project's impact continues beyond the project period.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Susanna Kunvik, PhD
- Número de telefone: +358447103204
- E-mail: susanna.kunvik@samk.fi
Estude backup de contato
- Nome: Petra Rautakallio-Järvinen, MSc
- Número de telefone: +358 50 359 7196
- E-mail: petra.rautakallio-jarvinen@samk.fi
Locais de estudo
-
-
Satakunta
-
Pori, Satakunta, Finlândia, 28130
- Satakunta University of Applied Sciences
-
Contato:
- Susanna Kunvik, PhD
- Número de telefone: +358447103204
- E-mail: susanna.kunvik@samk.fi
-
Contato:
- Elina Nevala, Msc
- Número de telefone: +358505737358
- E-mail: elina.nevala@samk.fi
-
Subinvestigador:
- Juha Puustinen, Doctor of Medicine
-
Subinvestigador:
- Petra Rautakallio-Järvinen, MsC
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Born in 1961 or earlier (i.e. aged over 65 years)
- Adequate Finnish language skills
- Able to give informed written consent
- Acting as a caregiver (with or without a formal caregiver contract) in the areas of Pori, Rauma, or Kankaanpää
- Normal cognition (participants with an MMSE score below 24 will be assessed by the responsible physician)
Exclusion Criteria:
- Serious acute illness or inability to act as an informal caregiver
- A condition, ailment, or underlying health risk that is poorly controlled and that participation in the study could exacerbate, or a terminal illness (Consultation of the doctor in charge, if necessary, in unclear cases)
- Born in 1961 or later (i.e. aged under 65 years)
- Substance abuse based on the AUDIT-C score (consultation of the doctor in charge)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Tailored nutritional counselling intervention
This is a single-arm pre-post study.
Participants in this arm are elderly family caregivers living in the Satakunta region.
All participants receive a 10-month tailored nutritional counselling intervention aimed at improving well-being, functional capacity, and dietary habits.
The intervention includes two individual dietary counselling sessions conducted by a nutrition specialist and three group counselling sessions.
Based on participants' preferences, the group sessions consist of either group-based nutrition lectures or practical cooking courses.
The individual counselling includes a personal nutrition plan.
|
The intervention is a 10-month tailored nutritional counselling programme for elderly family caregivers.
It includes two individual dietary counselling sessions conducted by a nutrition specialist and three group counselling sessions.
The individual counselling sessions include a personal nutrition plan based on the participant's needs.
According to participants' preferences, the group counselling sessions consist of either nutrition lectures or practical cooking courses.
The intervention aims to improve participants' well-being, functional capacity, and dietary habits.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mental well-being measured with the World Health Organization-Five Well-Being Index (WHO-5)
Prazo: Baseline and 10 months
|
Psychological well-being of participating informal caregivers will be assessed using the WHO-5 Well-Being Index.
The WHO-5 consists of five positively worded items measuring mood, vitality, positive affect, and general psychological well-being during the previous two weeks.
Each item is scored on a 6-point Likert scale from 0 to 5, giving a total raw score range of 0-25.
The raw score may be multiplied by 4 to obtain a transformed score from 0 to 100, where higher scores indicate better psychological well-being.
|
Baseline and 10 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Psychological burden measured with the Zarit Burden Interview, 4-item version (ZBI-4)
Prazo: Baseline and 10 months
|
Psychological burden of participating caregivers will be assessed using the 4-item version of the Zarit Burden Interview.
Each item is scored on a 5-point Likert scale from 0 to 4. The total score ranges from 0 to 16, with higher scores indicating greater psychological burden.
A score of 8 or higher indicates high caregiver burden.
|
Baseline and 10 months
|
|
Physical functioning measured with the five-times sit-to-stand test and hand grip strength measured with a grip dynamometer
Prazo: Baseline and 10 months
|
Physical functioning and lower-limb muscle strength will be assessed using the five-times sit-to-stand test.
Participants rise from a chair and sit down five times as quickly as possible, with arms crossed over the chest.
The outcome is the time needed to complete the test, measured in seconds.
A longer completion time indicates poorer lower-limb muscle strength and physical functioning.
Muscle strength will also be assessed using hand grip strength measured with a grip dynamometer.
The outcome is grip strength, with higher values indicating better muscle strength.
|
Baseline and 10 months
|
|
Protein intake measured with a 3-day food diary
Prazo: Baseline and 10 months.
|
Protein intake will be assessed using a 3-day food diary including two weekdays and one weekend day.
The outcomes include total daily protein intake and protein intake relative to body weight.
Protein intake will be reported as grams per day and grams per kilogram of body weight per day.
|
Baseline and 10 months.
|
|
Nutritional status measured with the Mini Nutritional Assessment, long form (MNA)
Prazo: Baseline and 10 months
|
Nutritional status will be assessed using the long form of the Mini Nutritional Assessment.
The MNA includes anthropometric measurements, dietary assessment, general health and functioning, and self-perceived health and nutritional status.
Participants will be classified as having normal nutritional status, being at risk of malnutrition, or being malnourished.
|
Baseline and 10 months
|
|
Quality of life measured with the 15D instrument
Prazo: Baseline and 10 months
|
Quality of life will be assessed using the 15D instrument.
The 15D includes 15 dimensions of health and functioning, each scored on five levels.
The responses are combined into a single 15D index score ranging from 0 to 1, where 0 represents death and 1 represents full health.
Higher scores indicate better health-related quality of life.
|
Baseline and 10 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Susanna Kunvik, Satakunta University of Applied Sciences
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SatakuntaUAS
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Qualidade de vida
-
Indiana UniversityRecrutamentoUltrassom Point of Care (POCUS)Estados Unidos
-
Aalborg UniversityConcluídoUltrassonografia Point of Care (POCUS)Dinamarca
-
Asociacion Española Primera en SaludIntensive Care Unit Pasteur HospitalConcluídoUltrassom Point of CareUruguai
-
Aga Khan UniversityThe Hospital for Sick Children; Grand Challenges CanadaDesconhecidoUltrassom Point of CarePaquistão
-
Medical University of WarsawRecrutamentoUltrassom Point of Care (POCUS) | Hemodynamic Assessment | Bedside UltrasonographyPolônia
-
University of BolognaRecrutamentoHemodiálise | Avaliação de Volume | Ultrassom Point of Care (POCUS)Itália
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); National Institute of Mental Health...ConcluídoTransgênero, HIV Continuum of CareEstados Unidos
-
Hospital for Special Surgery, New YorkConcluídoPeptídeo 1 semelhante ao glucagon | Ultrassom Gástrico | Ultrassom Point of CareEstados Unidos, Canadá
-
Thomas Jefferson UniversityConcluídoVentilação mecânica | Ultrassom Point of Care | Oxigenação | Ventilação Manual | Distúrbio da função cardíaca pós-operatórioEstados Unidos
-
Johann Wolfgang Goethe University HospitalConcluídoFormação de Coágulos e Agregação de Plaquetas em Testes Point of CareAlemanha