Independence in Self Care - A Program Focused on Nursing Care

January 30, 2019 updated by: Cecília Maria Rodrigues, Centro Hospitalar do Porto
This study is a randomized clinical trial conducted in a medical ward of an acute 580-bedded teaching hospital. One hundred fifty-eight older acute medical patients will be blindly randomly allocated to the control group or intervention group. The intervention will consist of a twice daily walking training, plus privileging trips to the toilet by walking and all daytime meals seated. Differences between groups will be measured at baseline (admission) and discharge. As primary outcomes, we defined the length of stay and the independence level. The independence level will be assessed at baseline (admission) and discharge by two distinct methods: through the Barthel Index and the Patient Classification Systems(PCS).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The intervention group will perform the training program while the control group will receive usual hospital care. As the study will be conducted in the same ward and due to the possible effect of subjects in the control group seeing subjects in the intervention group performing physical activity in addition to normal hospital care and because the service team itself may intervene involuntarily in the control group through increased activity, randomization will take place in a time dependent manner. Patients admitted for the first 12 weeks will be assigned to the control group. After these twelve weeks there will be a 3-week break and in the next 12 weeks (week 16 to 27) the admitted patients will be assigned to the intervention group. During the 3-week break, all members of the clinic staff will receive training on the intervention program.

All testing (at admission and discharge) will be performed in the same setting (Centro Hospitalar do Porto, Porto, Portugal) and by the same investigators.

Participants will include elderly people aged 65 years or older recruited from patients admitted into one of the three medical wards of the Centro Hospitalar do Porto (Porto, Portugal). Due to the length of the study it is possible a patient will be readmitted after participating in either the control or experimental group. To avoid this confounding variable, a study participant who is readmitted to the hospital during the course of the study will not be included in the study population a second time.

All clinical information will be obtained through direct observation of patients and consultation of medical records.

Interventions Usual care group (control) Participants assigned to the control group will receive usual hospital care, which includes physical rehabilitation when needed.

Intervention group (training) The intervention will consist of an twice daily walking training, plus privileging trips to the toilet by walking (with support devices or with support from people) and all daytime meals seated (not in bed). Attending of the particular and unexplored characteristics of the proposed intervention, namely the use of the toilet and meals, the proposed intervention extends throughout the 24 hours of the day, seven days a week. Therefore, it is an intervention that requires the alignment of the whole care team in its execution. The duration and quality of the training, planned for weeks 13 to 15, will be crucial to ensure the involvement of the whole team and the success of this study. We will re-organize the daily work of this particular service in order to focus nursing care on promoting independence in self-care.

Walk training will consist of walking as far as possible with or without assistance for 20 minutes. All training sessions will be individually monitored with a record of training completed compiled.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4099-001
        • Recruiting
        • Centro Hospitalar do Porto - Departamento Qualidade
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 65 years or older.
  • Able to ambulate, with or without personal/ technical assistance.
  • Able to communicate.

Exclusion Criteria:

  • Expected length of stay <72 hours
  • Patients permanently bedridden prior to admission

  • Any factor precluding performance of the physical training program. These factors include, but are not limited to the following:

    • Terminal illness.
    • Unstable cardiovascular disease or other medical condition.
    • Severe dementia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Usual Care Group
Intervention: Usual care
Other: Usual Care
Usual hospital care
Experimental: Intervention Group
Intervention:Promoting independence in self-care
Behavioral: Promoting independence in self-care
The intervention will consist of an twice daily walking training, plus privileging trips to the toilet by walking (with support devices or with support from people) and all daytime meals seated (not in bed). Attending of the particular and unexplored characteristics of the proposed intervention, namely the use of the toilet and meals, the proposed intervention extends throughout the 24 hours of the day, seven days a week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Independence level in self-care
Time Frame: The level of independence in self-care will be assessed at baseline (admission) and discharge through the Barthel Index
Barthel Index: The sum-score ranges from 0 (totally dependent) to 100 (totally independent)
The level of independence in self-care will be assessed at baseline (admission) and discharge through the Barthel Index

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro Hospitalar do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016.037(032-DEFI/032-CES)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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