Activities of Daily LivingNCT03106064
Independence in Self Care - A Program Focused on Nursing Care
A study testing Promoting independence in self-care in people with Activities of Daily Living and Hospitalization, run by Centro Hospitalar do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Activities of Daily Living, Hospitalization, Nursing Care
- What is being tested?
- Promoting independence in self-care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2017to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 65 years or older.
- Able to ambulate, with or without personal/ technical assistance.
- Able to communicate.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar do Porto - Departamento Qualidade
Porto, 4099-001
Cecília Rodrigues, 967025915, ceciliarodrigue@gmail.com
About this study
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).
Read the 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.
- Being tested
- Promoting independence in self-care, Usual Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting independence in self-careBehavioural
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.
Usual CareOther
Usual hospital care
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | Placebo comparator | Intervention: Usual care Receives: Other: Usual Care |
| Intervention Group | Experimental | Intervention:Promoting independence in self-care Receives: Behavioral: Promoting independence in self-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independence level in self-care
Barthel Index: The sum-score ranges from 0 (totally dependent) to 100 (totally independent)
Measured: The level of independence in self-care will be assessed at baseline (admission) and discharge through the Barthel Index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 May 2017
- Primary completion31 May 2018
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Activities of Daily LivingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecília Maria Rodrigues, Centro Hospitalar do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106064
- Sponsor's protocol ID
- 2016.037(032-DEFI/032-CES)
- Status last verified
- Jan 2019
- First submitted
- 27 Mar 2017
- Last updated
- 1 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31595258
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independence in Self Care - A Program Focused on Nursing Care
- ClinicalTrials.gov ID
- NCT03106064
- Acronym / sponsor ID
- 2016.037(032-DEFI/032-CES)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Centro Hospitalar do PortoUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | Placebo comparator | Other: Usual CareIntervention: Usual care |
| Intervention Group | Experimental | Behavioral: Promoting independence in self-careIntervention:Promoting independence in self-care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 65 years or older.
- Able to ambulate, with or without personal/ technical assistance.
- Able to communicate.
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promoting independence in self-careThe 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. | Behavioural | Intervention Group |
| Usual CareUsual hospital care | Other | Usual Care Group |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Derived from this study: PubMed 31595258Rodrigues 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centro Hospitalar do Porto - Departamento Qualidade
Porto, Portugal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting independence in self-care in people with Activities of Daily Living and Hospitalization, run by Centro Hospitalar do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03106064, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.