Independence in Self Care - A Program Focused on Nursing Care
1 other identifier
interventional
158
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Typical duration for not_applicable
1 active site
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
March 27, 2017
CompletedFirst Posted
Study publicly available on registry
April 10, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedFebruary 1, 2019
January 1, 2019
1.1 years
March 27, 2017
January 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Independence level in self-care
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
Study Arms (2)
Usual Care Group
PLACEBO COMPARATORIntervention: Usual care
Intervention Group
EXPERIMENTALIntervention:Promoting independence in self-care
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age: 65 years or older.
- Able to ambulate, with or without personal/ technical assistance.
- Able to communicate.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Hospitalar do Porto - Departamento Qualidade
Porto, 4099-001, Portugal
Related Publications (1)
Rodrigues C, Mendonca D, Martins MM. Effects of a nursing care program on functional outcomes in older acute medical in-patients: protocol for a randomized controlled trial. Porto Biomed J. 2018 Aug 1;4(2):e24. doi: 10.1016/j.pbj.0000000000000024. eCollection 2019 Mar-Apr.
PMID: 31595258DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nurse
Study Record Dates
First Submitted
March 27, 2017
First Posted
April 10, 2017
Study Start
May 1, 2017
Primary Completion
May 31, 2018
Study Completion
May 31, 2019
Last Updated
February 1, 2019
Record last verified: 2019-01