NCT06235593

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

January 23, 2024

Last Update Submit

February 3, 2024

Conditions

Keywords

Illness, Chronicquality of lifeelderly

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    9 months

Secondary Outcomes (1)

  • Health-related Quality of life

    9 months

Study Arms (1)

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

Behavioral: Self-care Intervention

Interventions

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;

Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de Évora

Evora, Portugal

RECRUITING

Related Publications (9)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Chronic DiseaseSelf-Control

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 1, 2024

Study Start

October 1, 2023

Primary Completion

July 1, 2024

Study Completion

October 1, 2024

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations