Dependence, DementiasNCT01965392
Efficiency of an Educational Program for Informal Caregivers of Hospitalized, Dependent Patients: Cluster Randomised Trial
A study testing Health education intervention in people with Dependence, Dementias, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal.
Trial summary
The aim was to assess whether nursing interventions based on Health Educational Programs for primary informal caregivers of dependent patients may improve their quality of life, decreasing emotional burden and increasing caregiving knowledge, in order to better meet patients' basic needs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dependence, Dementias
- What is being tested?
- Health education intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Mar 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary informal caregivers of dependent patients, admitted in 30 hospital units, with expected hospital stays of at least one week. A dependent patient is understood to require the aid of someone else in order to carry out basic daily activities.
Who cannot join
- caregivers with cognitive deficits that could be an obstacle for adequate verbal understanding, illiteracy, persons taking part in other clinical trials or who had taken part in similar workshops in the previous two years, as well as health professionals.
About this study
The aim was to assess whether nursing interventions based on Health Educational Programs for primary informal caregivers of dependent patients may improve their quality of life, decreasing emotional burden and increasing caregiving knowledge, in order to better meet patients' basic needs.
- Conditions
- Dependence, Dementias
- Being tested
- Health education intervention
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education interventionOther
'Health education intervention'
| Study group | Role | What they receive |
|---|---|---|
| healtn education | Experimental | one group received an educational program Receives: Other: Health education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
life quality
Measured: Data were evaluated with an average one month after discharge, a maximum in September 2009
Secondary outcomes (1)
Caregiver´s burden
Measured: Data were evaluated with an average one month after discharge, a maximum in September 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startMar 2009
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dependence, DementiasStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965392
- Sponsor's protocol ID
- ESCPD-2010
- Status last verified
- Oct 2013
- First submitted
- 7 Oct 2013
- Last updated
- 18 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of an Educational Program for Informal Caregivers of Hospitalized, Dependent Patients: Cluster Randomised Trial
- ClinicalTrials.gov ID
- NCT01965392
- Acronym / sponsor ID
- ESCPD-2010
- Conditions
- Dependence, Dementias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 18 Oct 2013 (estimated)
- 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.
The aim was to assess whether nursing interventions based on Health Educational Programs for primary informal caregivers of dependent patients may improve their quality of life, decreasing emotional burden and increasing caregiving knowledge, in order to better meet patients' basic needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healtn education | Experimental | Other: Health education interventionone group received an educational program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary informal caregivers of dependent patients, admitted in 30 hospital units, with expected hospital stays of at least one week. A dependent patient is understood to require the aid of someone else in order to carry out basic daily activities.
Key exclusion criteria (1 listed)
- caregivers with cognitive deficits that could be an obstacle for adequate verbal understanding, illiteracy, persons taking part in other clinical trials or who had taken part in similar workshops in the previous two years, as well as health professionals.
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 |
|---|---|---|
| Health education intervention'Health education intervention' | Other | healtn education |
Primary outcome
life quality
Time frame: Data were evaluated with an average one month after discharge, a maximum in September 2009
1 secondary outcome
Caregiver´s burden
Time frame: Data were evaluated with an average one month after discharge, a maximum in September 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Health education intervention in people with Dependence, Dementias, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
life quality (time frame: Data were evaluated with an average one month after discharge, a maximum in September 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2013.