Nursing Students' Visits to Older Adults With Multiple Chronic Conditions (VISITAME)

December 19, 2023 updated by: Jose Manuel Hernandez Padilla, Universidad de Almeria

Nursing Students' Visits to Older Adults With Multiple Chronic Conditions: Effects on Self-care and Other Related Variables (VISITAME)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04120
        • Universidad de Almeria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Participants 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.
Behavioral: Nursing students' home-visit programme

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.

Behavioral: Standard care from Public Andalusian Health Service
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.
Active Comparator: Control group
Participants allocated to the 'control group' arm will only receive the usual care offered by the Public Andalusian Healthcare Service for 12 weeks.
Behavioral: Standard care from Public Andalusian Health Service
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-care behaviours
Time Frame: 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.
Changes from baseline to 3-month and 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in loneliness
Time Frame: Changes from baseline to 3-month and 6-month follow-up
UCLA Loneliness Scale (UCLA). UCLA will be used to measure the variable 'loneliness'. This self-administered scale measures how often older people experience feelings of loneliness. The UCLA is comprised of 10 items to be answered using a 4-point Likert scale (1=I often feel this way, 4=I never feel this way). Lower scores are indicative of a greater feeling of loneliness. It is suggested that scores <20 points could indicate severe loneliness, while scores of 20-30 points could be indicative of moderate loneliness.
Changes from baseline to 3-month and 6-month follow-up
Change in perceived social support
Time Frame: Changes from baseline to 3-month and 6-month follow-up
DUKE-UNK-11 questionnaire of perceived social support (DUKE-11). The DUKE-11 will be used to measure the variable 'perceived social support'. The DUKE-11 questionnaire is self-administered and measures perceived functional social support with 11 items divided into two dimensions: 'confidant support' and 'affective support'. All items have 5 response options in Likert format (1=as much as I want, 5=much less than I want) and allow participants to indicate the frequency with which they receive social support. Scores can range from 11-55 points. Scores >32 points indicate low perceived social support.
Changes from baseline to 3-month and 6-month follow-up
Change in health-related quality of life
Time Frame: Changes from baseline to 3-month and 6-month follow-up
SF-12 quality of life questionnaire (SF-12). The SF-12 questionnaire will be used to measure the variable 'quality of life'. The SF-12 is a self-administered questionnaire that measures health-related quality of life in 12 items. The SF-12 is the shortened version of the SF-36. The SF-12 response options follow a Likert-type scale that assesses intensity or frequency, depending on the item. The number of response options for each item ranges from three to six and the total score must be transformed from 0 to 100. Higher scores indicate better health-related quality of life.
Changes from baseline to 3-month and 6-month follow-up
Change in dignity
Time Frame: Changes from baseline to 3-month and 6-month follow-up
Patient Dignity Inventory (PDI). The PDI will be used to measure the 'dignity' variable. The PDI is a self-administered instrument comprised of 25 items that are distributed in 3 dimensions: 'psychological and existential stress', 'physical symptoms and dependency' and 'social support'. Using a 5-point Likert scale (1=Not a problem, 5=Overwhelming problem), participants must respond to what degree certain situations related to dignity have been a problem or concern for them in the last few days. Higher scores indicate greater affectation in the participants' sense of dignity.
Changes from baseline to 3-month and 6-month follow-up
Change in personal autonomy
Time Frame: Changes from baseline to 3-month and 6-month follow-up
Maastricht Personal Autonomy Questionnaire (MPAQ). The MPAQ is a self-administered questionnaire comprised of 16 items divided into 3 dimensions. The 'dilemmas' dimension (6 items) measures the frequency with which older people experience conflicts between what they want to do and what is best for their health (1=never; 5=very often). The 'degree of autonomy' dimension measures the impact of dilemmas on the participants' autonomy (1=Not at all; 5=Yes, completely). The dimension 'working on autonomy' (5 items) measures the efforts made by the participants to maintain personal autonomy (1=No, not at all; 5=Yes, I do everything possible),. The total score of each dimension is calculated by adding the score of all the items and dividing it by the total number of items. Higher scores indicate that people face dilemmas more often, experience a greater degree of autonomy, and work harder to maintain or achieve their autonomy.
Changes from baseline to 3-month and 6-month follow-up
Change in falls
Time Frame: Changes from baseline to 3-month and 6-month follow-up
Number and place of falls in the last 6 months
Changes from baseline to 3-month and 6-month follow-up
Change in hospital admissions
Time Frame: Changes from baseline to 3-month and 6-month follow-up
Number and cause of hospital admissions in the last 6 months
Changes from baseline to 3-month and 6-month follow-up
Change in visits to emergency departments
Time Frame: Changes from baseline to 3-month and 6-month follow-up
Number and cause of visits to the emergency department in the last 6 months
Changes from baseline to 3-month and 6-month follow-up
Change in self-efficacy in self-care
Time Frame: Changes from baseline to 3-month and 6-month follow-up
The participants' self-efficacy in self-care will be assessed with the Self-Efficacy in Self-Care Scale (SESCS). The SESCS is comprised of 10 items that can be responded using a 5-point, Likert type scale (1=not confident; 5=extremely confident) and assess self-efficacy related to self-care maintenance, monitoring, and management in people diagnosed with chronic conditions. The participants' total scores will be standardised to range from 0-100, with higher scores indicating higher levels of self-efficacy.
Changes from baseline to 3-month and 6-month follow-up
Change in funcional capacity for activities of daily living
Time Frame: Changes from baseline to 3-month and 6-month follow-up
Barthel Index (BI). The BI will be used to measure the variable 'functional independence' to carry out the BADL. The BI is a unidimensional, hetero-administered questionnaire with 10 items measuring participants' independence for feeding, moving from chair to bed, doing personal toileting, getting on and off the toilet, bathing oneself, walking on a level surface or propelling a wheelchair, ascending and descending stairs, dressing and undressing, continence of bowels, and controlling bladder. The assessor can complete the questionnaire by direct observation or by interviewing the participant. The score can range from 0-100 (90 for people in wheelchairs) and the level of functional independence is determined by the score obtained: independent (100 points), mild dependency (≥ 60 points), moderate dependency (40-55 points), severe dependency (20-35 points), total dependency (< 20 points).
Changes from baseline to 3-month and 6-month follow-up
Change in nutritional status
Time Frame: Changes from baseline to 3-month and 6-month follow-up
Nutritional status will be assessed using the Mini Nutritional Assessment (MNA). The MNA is comprised of 18 items divided in two sections: screening and assessment. The screening section is comprised of 6 items that assess and will yield a total screening score that can be interpreted: a score ≥ 12 indicates the person is well nourished, a score of 8-11 indicates the person is at risk of malnutrition, and a score ≤ 7 indicates the person is malnourished. When the person's score ≤ 11, it is recommended to complete the assessment section to determine the factors that could be affecting their nutritional status. The assessment section is comprised of 12 weighted items (0-2 points per item) that must be added to the screening score to calculate a total MNA score. A person with a total MNA score of 24-30 is considered to have a normal nutritional status, whereas people with a total MNA score of 17-23.5 is at risk of malnourishment and people with a total MNA score < 17 are malnourished.
Changes from baseline to 3-month and 6-month follow-up
Change in diet quality
Time Frame: Changes from baseline to 3-month and 6-month follow-up
The participants' diet quality will be assessed using the Mediterranean Diet Adherence Screener (MEDAS). The MEDAS is comprised of 14 items that measure the degree of adherence to the typical Mediterranean dietary pattern. The MEDAS includes 12 questions on food consumption frequency and 2 questions on food intake habits considered typical of the Spanish Mediterranean diet. Each question is scored 0 or 1. A total score ≥ 9 indicates good adherence to the Mediterranean Diet.
Changes from baseline to 3-month and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Collaborators

Ministerio de Ciencia e Innovación, Spain

Investigators

  • Principal Investigator: José Manuel Hernández Padilla, PhD, Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID2020-117579RA-I00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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)

IPD Sharing Time Frame

Two years (24 months) after the study completion.

IPD Sharing Access Criteria

The PI must be contacted and a minimum number of co-authors from the research team must be included in any publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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