ClinicalTrials.gg
RecruitingNCT06235593Updated Feb 7, 2024

Self-care in the Person With Chronic Disease

An interventional study of Self-care Intervention in Chronic Disease and Self-Control, sponsored by University of Évora. Recruiting at 1 site in Portugal. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-02-07.

Primary conditionSelf-ControlRegistry: Chronic DiseaseReclassifiedWhy we changed it
Registry
Chronic Disease — the first condition term the registry derived for this study.
ClinicalTrials.gg
Self-Control
Why
  1. Chronic Disease is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Self-Control.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Évora · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jul 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled Oct 2023, registered Jan 2024).
  • Started Oct 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chronic Disease
  • Self-Control

Browse trials for

Keywords

  • Illness, Chronic
  • quality of life
  • elderly
03

In context

Self-Control Reclassified

168 studies on the registry are indexed under Self-Control; 22 are open to participants now.

This study's planned enrollment of 400 is above the median of 88 across 144 interventional studies indexed under Self-Control.

Browse Self-Control studies →

Lead sponsor

University of Évora is the lead sponsor of 34 studies on the registry; 10 are open to participants now.

Compared within Self-Control, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Chronic Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    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

    Behavioral: Self-care Intervention

Interventions

  • BehavioralSelf-care Intervention

    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;

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 9 months

  2. 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.

    Time frame: 9 months

  3. 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.

    Time frame: 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

    Time frame: 9 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 30753801 ↗
  • Gruneir 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 20829235 ↗
  • Goes 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 32019984 ↗
  • Martin 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 30056392 ↗
  • Goes 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 34001152 ↗
  • Luciani 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 35346104 ↗
  • Riegel 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 35655456 ↗
  • Okubo 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 2994340 ↗
  • Porter 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 ↗

Individual participant data

Plan to share: Undecided — The group plans to share all data after the individual project validation

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06235593
Lead sponsor
University of Évora
Responsible party
Cláudia Mendes (Principal Investigator, University of Évora) — Principal investigator
First posted
Feb 1, 2024
Start date
Oct 1, 2023
Primary completion
Jul 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Feb 7, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion