Clinical trial NCT05264207: Nursing Students' Visits to Older Adults With Multiple Chronic Conditions
Official title: Nursing Students' Visits to Older Adults With Multiple Chronic Conditions: Effects on Self-care and Other Related Variables (VISITAME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: chronic disease
older adult
self-care
home-visit
nursing student
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
First posted: 2022-03-03
Enrollment: 252
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Older adults who meet the inclusion criteria and voluntarily accept to participate in this study will be randomly allocated to one of two arms: intervention group (arm 1) or control group (arm 2). Participants from both arms will be assessed at the same time for data collection purposes (pre-test, post-test and 6-month follow-up) and they will be exposed to the experimental condition (intervention group) or the control condition (control group) at the same time for 12-weeks.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in self-care behaviours
timeFrame: Changes from baseline to 3-month and 6-month follow-up
Secondary outcomes:
measure: Change in self-efficacy in self-care
timeFrame: Changes from baseline to 3-month and 6-month follow-up
measure: Change in loneliness
timeFrame: Changes from baseline to 3-month and 6-month follow-up
measure: Change in perceived social support
timeFrame: Changes from baseline to 3-month and 6-month follow-up
measure: Change in funcional capacity for activities of daily living
timeFrame: Changes from baseline to 3-month and 6-month follow-up
measure: Change in nutritional status
timeFrame: Changes from baseline to 3-month and 6-month follow-up
measure: Change in diet quality
timeFrame: Changes from baseline to 3-month and 6-month follow-up
measure: Change in health-related quality of life
timeFrame: Changes from baseline to 3-month and 6-month follow-up
measure: Change in dignity
timeFrame: Changes from baseline to 3-month and 6-month follow-up
measure: Change in personal autonomy
timeFrame: Changes from baseline to 3-month and 6-month follow-up
measure: Change in falls
timeFrame: Changes from baseline to 3-month and 6-month follow-up
measure: Change in hospital admissions
timeFrame: Changes from baseline to 3-month and 6-month follow-up
measure: Change in visits to emergency departments
timeFrame: Changes from baseline to 3-month and 6-month follow-up
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Universidad de Almería
Study officials:
affiliation: Universidad de Almeria
name: José Manuel Hernández Padilla, PhD
role: PRINCIPAL_INVESTIGATOR
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