Nursing Students' Visits to Older Adults With Multiple Chronic Conditions: Effects on Self-care and Other Related Variables (VISITAME)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Change in self-care behaviours
研究概览
简要总结
BACKGROUND
The concurrence of multiple chronic conditions in older adults is associated with increased healthcare expenditure, increased hospital admissions, consultations and pharmaceutical expenditure. Having been diagnosed with multiple chronic conditions is associated with biopsychosocial health deterioration, worsening quality of life and increased mortality in older adults. Consequently, older adults with multiple chronic conditions present complex health statuses that require healthcare professional to focus on promoting health and independence through self-care.
Available evidence suggests that the implementation of programs with individualized interventions focused on health promotion could improve self-care and other related variables in older people with chronic conditions. In this regard, the World Health Organization recommends the implementation of community health promotion programs including at least 5 home-visits carried out by healthcare professionals to promote self-care, independence, and quality of life amongst older adults with chronic conditions. However, the evidence on the cost-effectiveness of such visiting programs is inconsistent, which makes it difficult to integrate them into the services offered by public-funded healthcare systems. In search of more effective interventions to improve self-care and other related variables amongst older adults with multiple chronic conditions, nursing student visits could be a valid, effective alternative. Some studies suggest that the implementation of periodic follow-up programs (visits or telephone calls) by nursing students not only improves their knowledge and attitudes in relation to the care of older adults, but they could also have a positive impact on patients.
STUDY'S HYPOTHESIS
A program of supervised visits carried out by nursing students will significantly improve self-care behaviors and other related variables amongst older adults with multiple chronic conditions.
AIM
The aim of the VISITAME project is to examine the short-term (12 weeks) and medium-term (6 months) effects of a nursing students' home-visit programme on self-care behaviors amongst older adults with multiple chronic conditions.
STUDY DESIGN
A parallel two-arm randomized controlled trial (RCT) will be carried out. Participants will be randomly assigned to either an intervention group (IG) or a control group (CG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The type of intervention on which the project is based does not allow for the participants to be masked and they will know to which group they are allocated. However, the team that will collect data (assessors) will not know the group to which each participant is allocated. To ensure assessor masking, participants will be instructed to never reveal the group to which they have been assigned and assessors will be instructed to never ask the participants to which group they have been assigned. The assessors will not participate in the recruitment process, the supervision of nursing students' home-visits, nor the data analysis process. The group to which the participants have been allocated will be numerically coded (not labelled) in the database and the researchers in charge of data analysis will not know which numerical code refers to the intervention group and which code refers to the control group.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years.
- •Having been diagnosed with more than one chronic condition.
- •Living at home (community-dwelling).
- •Signing the informed consent to participate in the study.
排除标准
- •Having cognitive impairment (Pfeiffer test > 2 failures).
- •Having been diagnosed with a psychiatric condition (for example: schizophrenia).
- •Being a beneficiary of any of the services offered by the Fund of the Spanish National System for Autonomy and Support for Dependency.
- •Being a beneficiary of private personal assistance to help with functional dependency.
- •Participate in a program of similar nature from any public or private entities.
结局指标
主要结局
Change in self-care behaviours
时间窗: Changes from baseline to 3-month and 6-month follow-up
Self-care in chronic illness inventory (SC-CII). The SC-CII will be used to measure the primary outcome of the study: 'self-care behaviours'. The SC-CII is a self-administered inventory, comprised of 20 items divided into 3 scales. The self-care maintenance scale is comprised of 8 items that measure, on a five-point Likert scale (1=never, 5=always), the frequency with which patients perform health-maintenance behaviors. The self-care monitoring scale is comprised of 5 items that measure, on a five-point Likert scale (1=never, 5=always), the frequency with which patients perform health-monitoring behaviors. The 'self-care management' scale is comprised of 7 items that measure, on a five-point Likert scale (1=not at all likely, 5=very likely), the probability for a patient to perform health-management behaviors. The scores of the three tools are calculated individually (between 0 and 100). Higher scores are indicative of better self-care.
次要结局
- Change in diet quality(Changes from baseline to 3-month and 6-month follow-up)
- Change in perceived social support(Changes from baseline to 3-month and 6-month follow-up)
- Change in funcional capacity for activities of daily living(Changes from baseline to 3-month and 6-month follow-up)
- Change in loneliness(Changes from baseline to 3-month and 6-month follow-up)
- Change in self-efficacy in self-care(Changes from baseline to 3-month and 6-month follow-up)
- Change in dignity(Changes from baseline to 3-month and 6-month follow-up)
- Change in falls(Changes from baseline to 3-month and 6-month follow-up)
- Change in visits to emergency departments(Changes from baseline to 3-month and 6-month follow-up)
- Change in health-related quality of life(Changes from baseline to 3-month and 6-month follow-up)
- Change in hospital admissions(Changes from baseline to 3-month and 6-month follow-up)
- Change in nutritional status(Changes from baseline to 3-month and 6-month follow-up)
- Change in personal autonomy(Changes from baseline to 3-month and 6-month follow-up)
研究者
Jose Manuel Hernandez Padilla
Associate Professor (Profesor Titular)
Universidad de Almeria