FallsPhase 2/3NCT01141166
Octabaix Intervention Study
A Phase 2/3 study testing nutritional and a rehabilitation plan. in people with Falls and Malnutrition, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Objective: To determine the effectiveness of an individual multifactorial intervention on falls and undernutrition risk in very older people in the community. Read more about this study
- Who is it for?
- Ages 85 to 85 years
- Conditions the study is for
- Falls, Malnutrition
- What is being tested?
- nutritional and a rehabilitation plan.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2009to Apr 2011
- Phase
- Phase 2/3
- 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 85 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects born in 1924 of one of the 7 participating health centers and noninstitutionalized
Who cannot join
- Institutionalized
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial on Falls and Malnutrition Prevention in the Community in 85 Year Old Subjects
Objective: To determine the effectiveness of an individual multifactorial intervention on falls and undernutrition risk in very older people in the community.
Read the detailed description
Design: Randomized, controlled trial.
Method: Three hundred and twenty eight people born in 1924, after recruitment will be followed for a three year period. Subjects received two in-home visits from a trained nurse or physicians who assessed falls and nutritional risk factors using an algorithm.
The intervention consisted of recommendations to the subject and their primary physician, and other providers, telephone calls, and exercise and nutritional plan. Control subjects received a general primary care assessment.
Measurements: the primary outcome were rate of falls and rate of undernourished risk. Secondary outcomes included different geriatrics characteristics.The outcomes of this study will provide important new information to reduce the incidence of falls and the risk of undernutrition of this population by intervention. Significant differences are not expected according to social-demographics sex and other factors, but they are expected by other obtained factors and indices that could allow to detection of octogenarian people with great risk of deterioration in just a short time.
- Conditions
- Falls, Malnutrition
- Being tested
- nutritional and a rehabilitation plan.
- Keywords
- ELDERLY, NUTRITION
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional and a rehabilitation plan.Behavioural
The intervention consisted of recommendations to the subject and their primary physician, and others providers, telephone calls of a nutritional and a rehabilitation plan.
| Study group | Role | What they receive |
|---|---|---|
| nutritional and physical rehabilitation plan | Experimental | Not described Receives: Behavioral: nutritional and a rehabilitation plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of falls and rate of undernutrition risk as MNA < 23,5
Nutritional risk was evaluated by the MNA questionnaire
Secondary outcomes (1)
Different geriatrics characteristics
Functional, cognitive and nutritional status and social risk were assessed by instruments currently used in geriatric practice. Functional status was measured using the BI (Mahoney and Barthel, 1965) for the basic ADL, and the Lawton index (LI) (Lawton and Brody, 1969). Cognitive function was measured by the Spanish version (MEC) (Lobo et al., 1999) of the MMSE. Comorbidity by the Charlson comorbidity index (CCI)and the others.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJan 2009
- Primary completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FallsStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141166
- Sponsor's protocol ID
- AFF2191
- Status last verified
- Jun 2010
- First submitted
- 14 Apr 2010
- Last updated
- 10 Jun 2010
- Results posted
- No
Publications
Badia T, Formiga F, Ferrer A, Sanz H, Hurtos L, Pujol R. Multifactorial assessment and targeted intervention in nutritional status among the older adults: a randomized controlled trial: the Octabaix study. BMC Geriatr. 2015 Apr 11;15:45. doi: 10.1186/s12877-015-0033-0.
PubMed 25887312Ferrer A, Formiga F, Sanz H, de Vries OJ, Badia T, Pujol R; OCTABAIX Study Group. Multifactorial assessment and targeted intervention to reduce falls among the oldest-old: a randomized controlled trial. Clin Interv Aging. 2014 Feb 25;9:383-93. doi: 10.2147/CIA.S57580. eCollection 2014.
PubMed 24596458
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial on Falls and Malnutrition Prevention in the Community in 85 Year Old Subjects
- ClinicalTrials.gov ID
- NCT01141166
- Acronym / sponsor ID
- AFF2191
- Conditions
- Falls, Malnutrition
- Keywords
- ELDERLY, NUTRITION
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
- Study start
- Jan 2009
- Primary completion
- Apr 2011 (estimated)
- First posted
- 10 Jun 2010 (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.
Objective: To determine the effectiveness of an individual multifactorial intervention on falls and undernutrition risk in very older people in the community.
Detailed description
Design: Randomized, controlled trial.
Method: Three hundred and twenty eight people born in 1924, after recruitment will be followed for a three year period. Subjects received two in-home visits from a trained nurse or physicians who assessed falls and nutritional risk factors using an algorithm.
The intervention consisted of recommendations to the subject and their primary physician, and other providers, telephone calls, and exercise and nutritional plan. Control subjects received a general primary care assessment.
Measurements: the primary outcome were rate of falls and rate of undernourished risk. Secondary outcomes included different geriatrics characteristics.The outcomes of this study will provide important new information to reduce the incidence of falls and the risk of undernutrition of this population by intervention. Significant differences are not expected according to social-demographics sex and other factors, but they are expected by other obtained factors and indices that could allow to detection of octogenarian people with great risk of deterioration in just a short time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nutritional and physical rehabilitation plan | Experimental | Behavioral: nutritional and a rehabilitation plan. |
Who may qualify
- Ages
- 85 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Subjects born in 1924 of one of the 7 participating health centers and noninstitutionalized
Key exclusion criteria (1 listed)
- Institutionalized
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 |
|---|---|---|
| nutritional and a rehabilitation plan.The intervention consisted of recommendations to the subject and their primary physician, and others providers, telephone calls of a nutritional and a rehabilitation plan. | Behavioural | nutritional and physical rehabilitation plan |
Primary outcome
Rate of falls and rate of undernutrition risk as MNA < 23,5
Nutritional risk was evaluated by the MNA questionnaire
1 secondary outcome
Different geriatrics characteristics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2010.
- Derived from this study: PubMed 25887312Badia T, Formiga F, Ferrer A, Sanz H, Hurtos L, Pujol R. Multifactorial assessment and targeted intervention in nutritional status among the older adults: a randomized controlled trial: the Octabaix study. BMC Geriatr. 2015 Apr 11;15:45. doi: 10.1186/s12877-015-0033-0.
- Derived from this study: PubMed 24596458Ferrer A, Formiga F, Sanz H, de Vries OJ, Badia T, Pujol R; OCTABAIX Study Group. Multifactorial assessment and targeted intervention to reduce falls among the oldest-old: a randomized controlled trial. Clin Interv Aging. 2014 Feb 25;9:383-93. doi: 10.2147/CIA.S57580. eCollection 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing nutritional and a rehabilitation plan. in people with Falls and Malnutrition, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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: status not confirmed, as of the sponsor's last update on 10 Jun 2010. 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 Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Rate of falls and rate of undernutrition risk as MNA < 23,5. 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 NCT01141166, which also lists 2 linked publications.
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 10 Jun 2010.