Nursing Students' Visits to Older Adults With Multiple Chronic Conditions (VISITAME)
Primary Purpose
Chronic Disease
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nursing students' home-visit programme
Standard care from Public Andalusian Health Service
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Disease focused on measuring chronic disease, older adult, self-care, home-visit, nursing student
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 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.
Sites / Locations
- Universidad de Almería
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
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.
Participants allocated to the 'control group' arm will only receive the usual care offered by the Public Andalusian Healthcare Service for 12 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in self-efficacy in self-care
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.
Change in loneliness
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.
Change in perceived social support
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.
Change in funcional capacity for activities of daily living
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).
Change in nutritional status
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.
Change in diet quality
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.
Change in health-related quality of life
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.
Change in dignity
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.
Change in personal autonomy
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.
Change in falls
Number and place of falls in the last 6 months
Change in hospital admissions
Number and cause of hospital admissions in the last 6 months
Change in visits to emergency departments
Number and cause of visits to the emergency department in the last 6 months
Full Information
NCT ID
NCT05264207
First Posted
February 14, 2022
Last Updated
June 28, 2023
Sponsor
Universidad de Almeria
Collaborators
Ministerio de Ciencia e Innovación, Spain
1. Study Identification
Unique Protocol Identification Number
NCT05264207
Brief Title
Nursing Students' Visits to Older Adults With Multiple Chronic Conditions
Acronym
VISITAME
Official Title
Nursing Students' Visits to Older Adults With Multiple Chronic Conditions: Effects on Self-care and Other Related Variables (VISITAME)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria
Collaborators
Ministerio de Ciencia e Innovación, Spain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
chronic disease, older adult, self-care, home-visit, nursing student
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants allocated to the 'control group' arm will only receive the usual care offered by the Public Andalusian Healthcare Service for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Nursing students' home-visit programme
Intervention Description
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:
Self-care of chronic conditions and medication management
Healthy habits: physical activity and healthy eating
Access to social support resources
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard care from Public Andalusian Health Service
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in self-care behaviours
Description
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.
Time Frame
Changes from baseline to 3-month and 6-month follow-up
Secondary Outcome Measure Information:
Title
Change in self-efficacy in self-care
Description
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.
Time Frame
Changes from baseline to 3-month and 6-month follow-up
Title
Change in loneliness
Description
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.
Time Frame
Changes from baseline to 3-month and 6-month follow-up
Title
Change in perceived social support
Description
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.
Time Frame
Changes from baseline to 3-month and 6-month follow-up
Title
Change in funcional capacity for activities of daily living
Description
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).
Time Frame
Changes from baseline to 3-month and 6-month follow-up
Title
Change in nutritional status
Description
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.
Time Frame
Changes from baseline to 3-month and 6-month follow-up
Title
Change in diet quality
Description
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.
Time Frame
Changes from baseline to 3-month and 6-month follow-up
Title
Change in health-related quality of life
Description
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.
Time Frame
Changes from baseline to 3-month and 6-month follow-up
Title
Change in dignity
Description
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.
Time Frame
Changes from baseline to 3-month and 6-month follow-up
Title
Change in personal autonomy
Description
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.
Time Frame
Changes from baseline to 3-month and 6-month follow-up
Title
Change in falls
Description
Number and place of falls in the last 6 months
Time Frame
Changes from baseline to 3-month and 6-month follow-up
Title
Change in hospital admissions
Description
Number and cause of hospital admissions in the last 6 months
Time Frame
Changes from baseline to 3-month and 6-month follow-up
Title
Change in visits to emergency departments
Description
Number and cause of visits to the emergency department in the last 6 months
Time Frame
Changes from baseline to 3-month and 6-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Manuel Hernández Padilla, PhD
Organizational Affiliation
Universidad de Almeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Almería
City
Almería
ZIP/Postal Code
04120
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
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Nursing Students' Visits to Older Adults With Multiple Chronic Conditions
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