NCT04997746

Brief Summary

INTRODUCTION: aging is the natural process of deterioration of the reserves of biological systems, human beings are inherent to this process. The elderly population in Brazil grows very quickly, this is due to the drop in fertility, mortality and increased life expectancy. OBJECTIVE: to promote the planning of guiding and educational actions based on the qualification of the frailty of the elderly in the Basic Health Unit of the study through the use of the Multidimensional Assessment of the Elderly in Primary Care (AMPI/AB) tool. METHODOLOGY: an experimental, longitudinal, prospective and analytical study aimed at approximately 20 pre-frail elderly people residing in a specific area of a Family Health Unit in the city of Guarulhos/SP. A survey of data referring to the application of AMPI/AB carried out in 2021 and classified as pre-fragile will be carried out, in order to later select them for research. The participant will receive educational guidance on nutrition, use of medications and nursing guidance as identified as needs. Three months after the intervention, AMPI/AB will be applied in order to observe whether the pre-frail elderly remained or changed category after the experimental multidisciplinary educational interventions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

July 24, 2021

Last Update Submit

August 9, 2021

Conditions

Keywords

Elderly healthPatient Care TeamFamily health strategyPrimary Health Care

Outcome Measures

Primary Outcomes (3)

  • Correct use of medications

    Adequacy of the correct use of medications with the use of the medication box. subjective outcome

    3 months

  • Advances in quality of life (subjective)

    Offering guidelines on the health of the elderly, providing them with healthier aging and quality of life, covering critical points of the elderly's health and preventing health problems, providing advances in their self-care and giving them more autonomy, solving doubts related to their comorbidities and the aging process, bringing comfort to their anguish, also including the process of death. Subjective outcome

    3 months

  • Calculation of Body Mass Index

    Elderly people are expected to remain within the anthropometric parameters according to their age group, based on the calculation of BMI in kg / m \^ 2 (obtained by combining weight (in kilograms) and height (in meters)

    3 months

Study Arms (3)

educational pharmaceutical guidelines

Qualified listening of participants; General pharmaceutical educational guidelines on the use of medicines; Manufacture and supply of medicine organizer boxes.

Behavioral: Multiprofessional educational interventions

Nursing Educational Guidelines

Nursing educational guidelines; Qualified listening to participants to resolve doubts related to their comorbidities and aging, bringing comfort in relation to their anxieties. Nursing interventions will occur through verbal educational guidelines given individually and according to the reality of each participant assessed by the research, based on the nursing diagnoses obtained from the North American Nursing Diagnosis Association - NANDA-I (definitions and classification 2018- 2020) 11th edition.

Behavioral: Multiprofessional educational interventions

Nutritional Educational Guidelines

Obtaining anthropometric measurements (weight, in kilograms, height (in meters), knee height, arm and calf circumference (in centimeters) to trace the participant's nutritional profile and, subsequently, personalized and appropriate nutritional guidelines will be carried out for each situation The calculation of the Body Mass Index (BMI) must be performed by dividing the weight (W) in kilograms (kg) by the square of the height (H) in meters (m) and indicates the individual's nutritional status. The BMI for the elderly (LIPSCHITZ, 1994 apud TAVARES et al., 2015) determines underweight less than or equal to 22kg / m2, adequate or eutrophic weight between 22 and 27kg / m2 and overweight result greater than or equal to 27kg / m2 .

Behavioral: Multiprofessional educational interventionsOther: Measurement of anthropometric measurements

Interventions

Preventive educational interventions

Nursing Educational GuidelinesNutritional Educational Guidelineseducational pharmaceutical guidelines

Measurement of height (in meters), weight (in kilograms), knee height, arm circumference and calf circumference (in centimeters)

Nutritional Educational Guidelines

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly participants previously classified as pre-frail based on the Multidimensional Assessment of the Elderly instrument

You may qualify if:

  • Time and space oriented seniors;
  • Previously classified as pre-fragile;
  • Good physical condition for taking anthropometric measurements;
  • Who voluntarily agreed to participate in the research;

You may not qualify if:

  • Elderly classified as "healthy";
  • Unsatisfactory physical condition that makes it impossible to measure anthropometric measurements;
  • Elderly with amputated limbs;
  • In palliative care;
  • Who refuse to voluntarily participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guarulhos City Hall

Guarulhos, São Paulo, 07175530, Brazil

Location

Study Officials

  • Leonardo Matos

    Guarulhos City Hall

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Advisor

Study Record Dates

First Submitted

July 24, 2021

First Posted

August 10, 2021

Study Start

August 1, 2021

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

August 16, 2021

Record last verified: 2021-08

Locations