Nursing Students' Visits to Older Adults With Multiple Chronic Conditions
VISITAME
1 other identifier
interventional
252
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2022
CompletedFirst Posted
Study publicly available on registry
March 3, 2022
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedDecember 20, 2023
December 1, 2023
1.3 years
February 14, 2022
December 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in self-care behaviours
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.
Changes from baseline to 3-month and 6-month follow-up
Secondary Outcomes (12)
Change in self-efficacy in self-care
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 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 nutritional status
Changes from baseline to 3-month and 6-month follow-up
- +7 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALParticipants allocated to the 'intervention group' arm will receive the usual care offered by the Public Andalusian Healthcare Service in conjunction with a 12-week nursing students' home-visit programme.
Control group
ACTIVE COMPARATORParticipants allocated to the 'control group' arm will only receive the usual care offered by the Public Andalusian Healthcare Service for 12 weeks.
Interventions
12-week home-visit program conducted by nursing students. Participants will receive weekly 45-minute visits. The visits will aim to promote self-care behaviours and will focus on: 1. Self-care of chronic conditions and medication management 2. Healthy habits: physical activity and healthy eating 3. Access to social support resources 4. Patients' rights and autonomous decision-making The visits program will follow the WHO recommendations for the implementation of health promotion activities. All topics will be assigned 3 visits. In the first visit, the students will assess the participants' information needs and preferences in relation to the topic addressed and will provide generic information about it. In the second visit, the students will present individually-tailored information and will use individually-adapted strategies to convey such information. In the third visit, the student will explore the impact of the two previous visits and reinforce self-care behaviours.
Standard care offered by the Public Andalusian Health Service in its portfolio of services for older adults with multiple chronic conditions and complex health conditions. As part of these services, older adults with multiple chronic conditions receive generic, written information on healthy eating, adapted physical activity, abandonment of toxic habits, environmental safety and emotional management when they are first diagnosed with a chronic condition. The action plans or protocols established in the care processes aimed at older people with chronic multimnorbidity do not include periodic home visits.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad de Almerialead
- Ministerio de Ciencia e Innovación, Spaincollaborator
Study Sites (1)
Universidad de AlmerÃa
AlmerÃa, 04120, Spain
Related Publications (64)
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PMID: 32393249BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José Manuel Hernández Padilla, PhD
Universidad de Almeria
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor (Profesor Titular)
Study Record Dates
First Submitted
February 14, 2022
First Posted
March 3, 2022
Study Start
March 15, 2022
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
December 20, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Two years (24 months) after the study completion.
- Access Criteria
- The PI must be contacted and a minimum number of co-authors from the research team must be included in any publication
All IPD will be shared once the study is finalised and the main results are published. IPD can be obtained by contacting the responsible party (j.hernandez-padilla@ual.es)