Chronic DiseaseNCT06235593
Self-care in the Person With Chronic Disease
A study testing Self-care Intervention in people with Chronic Disease and Self-Control, run by University of Évora at 1 site in Portugal.
Trial summary
Determine the nursing care needs of the elderly population sample according to the self-care deficits identified using the "Self-Care of Chronic Illness Inventory - Patient Version (version 4)" in elderly population living in their own homes or in the homes of relatives or friends in the district of Évora. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Disease, Self-Control
- What is being tested?
- Self-care Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- are aged 65 or older
- are interested in participating in the project
- are residing Évora district in their own homes or at family members' or friends' homes
- can make their own decisions if they were sick or were hospitalized due to acute, short-term health care needs
- present at least one chronic disease.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Universidade de Évora
Evora
Cláudia Amaro Dos Santos, PhD Student, 968575053, cmendes@hevora.min-saude.pt
CRI.COM Centre
About this study
Official title: Self-care in the Person With Chronic Disease: A Protocol for a Self-care Intervention
Determine the nursing care needs of the elderly population sample according to the self-care deficits identified using the "Self-Care of Chronic Illness Inventory - Patient Version (version 4)" in elderly population living in their own homes or in the homes of relatives or friends in the district of Évora.
Read the detailed description
An assessment of the Portuguese health system estimates the overall burden of chronic diseases in the Portuguese population (regardless of age/gender) is follows: (i) 18% of Portuguese users of the National Health System have one chronic disease, (ii) 11% of users have two chronic diseases, (iii) 8% of users have three chronic diseases, and (iv) 22% of users have four or more chronic diseases; therefore, at least 59% of the Portuguese population has one or more chronic diseases (estimate). Moreover, the same report reveals that multimorbidity increases with age, with a maximum between 80 and 90 years old. Moreover, according to the research published in 2019 concerning the first National Health Examination Survey, the authors reported a high prevalence of multimorbidity among individuals aged 65 and older, estimated at 78.3% for the Portuguese population sample used in their research (estimates reported by age groups of 65-69, 70-74, 75-79 and 80 years and older: 72.8%, 78.2%, 81.9%, and 83.4%, respectively). Studying individual aging by integrating a continuous and accessible care model that allows elderly individuals as well as family caregivers to monitor and manage their health at home- always under the supervision of health professionals, which may enable the management of various chronic conditions (multimorbidity) and provide a "safety net" before a health crisis requiring emergency department care occurs. To promote improved health-related quality of life among elderly individuals by requalifying their potential and allowing them to live more autonomously, the following tasks are essential to identify the appropriate self-care behavior that allows determining, planning, and assessing preventive nursing care needs. Health care for patients with multimorbidity and applicable intervention strategies yield better outcomes when structured based on a previous evaluation of the patient's self-care deficits.
Most aging populations report chronic illnesses, which are usually permanent or recurrent, significantly affect well-being and quality of life, require daily and consistent healthcare management and last more than three months. With chronic illness now the significant health threat and the primary driver of healthcare costs, researchers, healthcare providers, and payers are focusing on interventions that can prevent or control exacerbations. In this context, the importance of self-care is increasingly recognized.
Self-care is essential in aging, mainly when changes occur in the person's health condition. Theoretically, this process involves three linked sequential behaviors captured in the critical concepts of self-care maintenance, self-care monitoring, and self-care management. Self-care maintenance addresses behaviors used by patients with a chronic illness to maintain physical and emotional stability (e.g., medication adherence), while self-care monitoring involves the behavior of observing oneself for signs and symptoms(e.g., checking blood pressure). Self-care monitoring is the link or bridge between self-care maintenance and self-care management. A core goal of self-care monitoring is symptom recognition; once recognized, self-care management (e.g., taking medicine for a symptom) can occur, with behaviors that reflect a response to the observed symptoms. There are two approaches to measurement: generic and disease-specific. Generic measures apply to a wide variety of patients. Disease-specific measures are helpful in specific groups with a single condition. Disease-specific measures are more responsive because they target issues experienced by patients with an explicit condition. Generic measures allow comparison among patients with different conditions and accommodate those with more than one diagnosis. The instrument studied within this project's scope, the "Self-Care of Chronic Illness Inventory - Patient Version" (version 4), is a generic measure designed to assess the process of self-care used by individuals with various chronic conditions.
- Conditions
- Chronic Disease, Self-Control
- Being tested
- Self-care Intervention
- Keywords
- Illness, Chronic, quality of life, elderly
- Medical subject headings
- Chronic Disease, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-care InterventionBehavioural
The intervention will focus on self-care behavior of people with chronic diseases according to two distinct periods (through a longitudinal study - follow-up nursing interventions):
(i) baseline; and (ii) 4 months;
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention will be a combination of interviews and face-to-face follow-ups, with teleconsultations, based on other observational and experimental studies. The intervention program includes monitoring for 9 months Receives: Behavioral: Self-care Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Care Maintenance
Eigth items questionnaire - Self-Care of Chronic Illness Inventory - Patient Version; Minimum -1 value and maximum- 5 value; higher scores mean a better outcomes.
Measured: 9 months
Self-Care Monitoring
Six items questionnaire - Self-Care of Chronic Illness Inventory - Patient Version; Minimum -1 value and maximum- 5 value; higher scores mean a better outcomes.
Measured: 9 months
Self-Care Management
Six items questionnaire - Self-Care of Chronic Illness Inventory - Patient Version; Minimum -1 value and maximum- 5 value; higher scores mean a better outcomes.
Measured: 9 months
Secondary outcomes (1)
Health-related Quality of life
Quality of life will be assessed using the WHOQOL-BREF(PT); Minimum - 0 value and maximum- 100 value; higher scores mean a better outcomes.
Quality of life will be assessed using the general health and well-being questionnaire
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Oct 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cláudia Mendes, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235593
- Sponsor's protocol ID
- CHRC052023
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The group plans to share all data after the individual project validation
Publications
Quinaz Romana G, Kislaya I, Salvador MR, Cunha Goncalves S, Nunes B, Dias C. [Multimorbidity in Portugal: Results from The First National Health Examination Survey]. Acta Med Port. 2019 Feb 1;32(1):30-37. doi: 10.20344/amp.11227. Epub 2019 Feb 1. Portuguese.
PubMed 30753801Gruneir A, Silver MJ, Rochon PA. Emergency department use by older adults: a literature review on trends, appropriateness, and consequences of unmet health care needs. Med Care Res Rev. 2011 Apr;68(2):131-55. doi: 10.1177/1077558710379422. Epub 2010 Sep 9.
PubMed 20829235Goes M, Lopes MJ, Oliveira H, Fonseca C, Maroco J. A Nursing Care Intervention Model for Elderly People to Ascertain General Profiles of Functionality and Self Care Needs. Sci Rep. 2020 Feb 4;10(1):1770. doi: 10.1038/s41598-020-58596-1.
PubMed 32019984Martin Lesende I, Mendibil Crespo LI, Castano Manzanares S, Otter AD, Garaizar Bilbao I, Pison Rodriguez J, Negrete Perez I, Sarduy Azcoaga I, de la Rua Fernandez MJ. Functional decline and associated factors in patients with multimorbidity at 8 months of follow-up in primary care: the functionality in pluripathological patients (FUNCIPLUR) longitudinal descriptive study. BMJ Open. 2018 Jul 28;8(7):e022377. doi: 10.1136/bmjopen-2018-022377.
PubMed 30056392Goes M, Lopes M, Maroco J, Oliveira H, Fonseca C. Psychometric properties of the WHOQOL-BREF(PT) in a sample of elderly citizens. Health Qual Life Outcomes. 2021 May 17;19(1):146. doi: 10.1186/s12955-021-01783-z.
PubMed 34001152Luciani M, De Maria M, Page SD, Barbaranelli C, Ausili D, Riegel B. Measuring self-care in the general adult population: development and psychometric testing of the Self-Care Inventory. BMC Public Health. 2022 Mar 28;22(1):598. doi: 10.1186/s12889-022-12913-7.
PubMed 35346104Riegel B, De Maria M, Barbaranelli C, Matarese M, Ausili D, Stromberg A, Vellone E, Jaarsma T. Symptom Recognition as a Mediator in the Self-Care of Chronic Illness. Front Public Health. 2022 May 17;10:883299. doi: 10.3389/fpubh.2022.883299. eCollection 2022.
PubMed 35655456Okubo K, Sei Y, Matsuo Y, Sagawa K, Natori H, Yokoyama MM. [Tac antigen expression on non-T non-B acute lymphocytic leukemia cells]. Nihon Ketsueki Gakkai Zasshi. 1985 May;48(3):794-801. No abstract available. Japanese.
PubMed 2994340Porter ME, Larsson S, Lee TH. Standardizing Patient Outcomes Measurement. N Engl J Med. 2016 Feb 11;374(6):504-6. doi: 10.1056/NEJMp1511701. No abstract available.
PubMed 26863351
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-care in the Person With Chronic Disease: A Protocol for a Self-care Intervention
- ClinicalTrials.gov ID
- NCT06235593
- Acronym / sponsor ID
- CHRC052023
- Conditions
- Chronic Disease, Self-Control
- Keywords
- Illness, Chronic, quality of life, elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the nursing care needs of the elderly population sample according to the self-care deficits identified using the "Self-Care of Chronic Illness Inventory - Patient Version (version 4)" in elderly population living in their own homes or in the homes of relatives or friends in the district of Évora.
Detailed description
An assessment of the Portuguese health system estimates the overall burden of chronic diseases in the Portuguese population (regardless of age/gender) is follows: (i) 18% of Portuguese users of the National Health System have one chronic disease, (ii) 11% of users have two chronic diseases, (iii) 8% of users have three chronic diseases, and (iv) 22% of users have four or more chronic diseases; therefore, at least 59% of the Portuguese population has one or more chronic diseases (estimate). Moreover, the same report reveals that multimorbidity increases with age, with a maximum between 80 and 90 years old. Moreover, according to the research published in 2019 concerning the first National Health Examination Survey, the authors reported a high prevalence of multimorbidity among individuals aged 65 and older, estimated at 78.3% for the Portuguese population sample used in their research (estimates reported by age groups of 65-69, 70-74, 75-79 and 80 years and older: 72.8%, 78.2%, 81.9%, and 83.4%, respectively). Studying individual aging by integrating a continuous and accessible care model that allows elderly individuals as well as family caregivers to monitor and manage their health at home- always under the supervision of health professionals, which may enable the management of various chronic conditions (multimorbidity) and provide a "safety net" before a health crisis requiring emergency department care occurs. To promote improved health-related quality of life among elderly individuals by requalifying their potential and allowing them to live more autonomously, the following tasks are essential to identify the appropriate self-care behavior that allows determining, planning, and assessing preventive nursing care needs. Health care for patients with multimorbidity and applicable intervention strategies yield better outcomes when structured based on a previous evaluation of the patient's self-care deficits.
Most aging populations report chronic illnesses, which are usually permanent or recurrent, significantly affect well-being and quality of life, require daily and consistent healthcare management and last more than three months. With chronic illness now the significant health threat and the primary driver of healthcare costs, researchers, healthcare providers, and payers are focusing on interventions that can prevent or control exacerbations. In this context, the importance of self-care is increasingly recognized.
Self-care is essential in aging, mainly when changes occur in the person's health condition. Theoretically, this process involves three linked sequential behaviors captured in the critical concepts of self-care maintenance, self-care monitoring, and self-care management. Self-care maintenance addresses behaviors used by patients with a chronic illness to maintain physical and emotional stability (e.g., medication adherence), while self-care monitoring involves the behavior of observing oneself for signs and symptoms(e.g., checking blood pressure). Self-care monitoring is the link or bridge between self-care maintenance and self-care management. A core goal of self-care monitoring is symptom recognition; once recognized, self-care management (e.g., taking medicine for a symptom) can occur, with behaviors that reflect a response to the observed symptoms. There are two approaches to measurement: generic and disease-specific. Generic measures apply to a wide variety of patients. Disease-specific measures are helpful in specific groups with a single condition. Disease-specific measures are more responsive because they target issues experienced by patients with an explicit condition. Generic measures allow comparison among patients with different conditions and accommodate those with more than one diagnosis. The instrument studied within this project's scope, the "Self-Care of Chronic Illness Inventory - Patient Version" (version 4), is a generic measure designed to assess the process of self-care used by individuals with various chronic conditions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Self-care InterventionThe intervention will be a combination of interviews and face-to-face follow-ups, with teleconsultations, based on other observational and experimental studies. The intervention program includes monitoring for 9 months |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- are aged 65 or older
- are interested in participating in the project
- are residing Évora district in their own homes or at family members' or friends' homes
- can make their own decisions if they were sick or were hospitalized due to acute, short-term health care needs
- present at least one chronic disease.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-care InterventionThe intervention will focus on self-care behavior of people with chronic diseases according to two distinct periods (through a longitudinal study - follow-up nursing interventions): (i) baseline; and (ii) 4 months; | Behavioural | Intervention Group |
Primary outcome
Self-Care Maintenance
Time frame: 9 months
Eigth items questionnaire - Self-Care of Chronic Illness Inventory - Patient Version; Minimum -1 value and maximum- 5 value; higher scores mean a better outcomes.
Self-Care Monitoring
Time frame: 9 months
Six items questionnaire - Self-Care of Chronic Illness Inventory - Patient Version; Minimum -1 value and maximum- 5 value; higher scores mean a better outcomes.
Self-Care Management
Time frame: 9 months
Six items questionnaire - Self-Care of Chronic Illness Inventory - Patient Version; Minimum -1 value and maximum- 5 value; higher scores mean a better outcomes.
1 secondary outcome
Health-related Quality of life
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Results publication: PubMed 30753801Quinaz Romana G, Kislaya I, Salvador MR, Cunha Goncalves S, Nunes B, Dias C. [Multimorbidity in Portugal: Results from The First National Health Examination Survey]. Acta Med Port. 2019 Feb 1;32(1):30-37. doi: 10.20344/amp.11227. Epub 2019 Feb 1. Portuguese.
- Results publication: PubMed 20829235Gruneir A, Silver MJ, Rochon PA. Emergency department use by older adults: a literature review on trends, appropriateness, and consequences of unmet health care needs. Med Care Res Rev. 2011 Apr;68(2):131-55. doi: 10.1177/1077558710379422. Epub 2010 Sep 9.
- Results publication: PubMed 32019984Goes M, Lopes MJ, Oliveira H, Fonseca C, Maroco J. A Nursing Care Intervention Model for Elderly People to Ascertain General Profiles of Functionality and Self Care Needs. Sci Rep. 2020 Feb 4;10(1):1770. doi: 10.1038/s41598-020-58596-1.
- Results publication: PubMed 30056392Martin Lesende I, Mendibil Crespo LI, Castano Manzanares S, Otter AD, Garaizar Bilbao I, Pison Rodriguez J, Negrete Perez I, Sarduy Azcoaga I, de la Rua Fernandez MJ. Functional decline and associated factors in patients with multimorbidity at 8 months of follow-up in primary care: the functionality in pluripathological patients (FUNCIPLUR) longitudinal descriptive study. BMJ Open. 2018 Jul 28;8(7):e022377. doi: 10.1136/bmjopen-2018-022377.
- Results publication: PubMed 34001152Goes M, Lopes M, Maroco J, Oliveira H, Fonseca C. Psychometric properties of the WHOQOL-BREF(PT) in a sample of elderly citizens. Health Qual Life Outcomes. 2021 May 17;19(1):146. doi: 10.1186/s12955-021-01783-z.
- Results publication: PubMed 35346104Luciani M, De Maria M, Page SD, Barbaranelli C, Ausili D, Riegel B. Measuring self-care in the general adult population: development and psychometric testing of the Self-Care Inventory. BMC Public Health. 2022 Mar 28;22(1):598. doi: 10.1186/s12889-022-12913-7.
- Results publication: PubMed 35655456Riegel B, De Maria M, Barbaranelli C, Matarese M, Ausili D, Stromberg A, Vellone E, Jaarsma T. Symptom Recognition as a Mediator in the Self-Care of Chronic Illness. Front Public Health. 2022 May 17;10:883299. doi: 10.3389/fpubh.2022.883299. eCollection 2022.
- Results publication: PubMed 2994340Okubo K, Sei Y, Matsuo Y, Sagawa K, Natori H, Yokoyama MM. [Tac antigen expression on non-T non-B acute lymphocytic leukemia cells]. Nihon Ketsueki Gakkai Zasshi. 1985 May;48(3):794-801. No abstract available. Japanese.
- Results publication: PubMed 26863351Porter ME, Larsson S, Lee TH. Standardizing Patient Outcomes Measurement. N Engl J Med. 2016 Feb 11;374(6):504-6. doi: 10.1056/NEJMp1511701. No abstract available.
- Individual participant dataSharing planned: Undecided. The group plans to share all data after the individual project validation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-care Intervention in people with Chronic Disease and Self-Control, run by University of Évora at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Care Maintenance (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06235593, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.