Implementation StrategiesNCT01861366
Implementation of Nutritional Guidelines and Effects in Nursing Home Residents
A study testing A one year multifaceted implementation strategy and A three hour lecture about the guidelines in people with Implementation Strategies and Nutritional Outcome of Nursing Home Residents, run by Uppsala University at 1 site in Sweden.
Trial summary
The aim of this study is to examine two implementation strategies (external facilitation and educational outreach visit) when introducing nutritional guidelines in the elderly care setting and to evaluate the results of the implementation by clinical outcome measures of the nursing home residents. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implementation Strategies, Nutritional Outcome of Nursing Home Residents
- What is being tested?
- A one year multifaceted implementation strategy and A three hour lecture about the guidelines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSweden
- Study dates
- May 2009to Jun 2011
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age of 65 or older
- nursing home resident
- persons who manage the examination methods (interviews and blood samples)
Who cannot join
- persons in terminal stage of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome in Nursing Home Residents After Implementation of Nutritional Guidelines
The aim of this study is to examine two implementation strategies (external facilitation and educational outreach visit) when introducing nutritional guidelines in the elderly care setting and to evaluate the results of the implementation by clinical outcome measures of the nursing home residents.
The hypothesis is that the residents affected by the external facilitation strategy will stay stable in the measured clinical outcomes, while the residents influenced by the educational outreach visit will deteriorate during the implementation process.
- Being tested
- A one year multifaceted implementation strategy, A three hour lecture about the guidelines
- Keywords
- Implementation, Guidelines, Nutrition, Nursing home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A one year multifaceted implementation strategyOther
A three hour lecture about the guidelinesOther
| Study group | Role | What they receive |
|---|---|---|
| External facilitator | Experimental | The external facilitation is a one year multifaceted intervention, including support, guidance, practice audit and feedback, training targeted to a team of practitioners involving the unit manager, the nurses and diet aides at the nursing home. The facilitator is a researcher and dietician. Receives: Other: A one year multifaceted implementation strategy |
| Educational outreach visit | Active comparator | The outreach visit is a three hour lecture about the nutritional guidelines targeted to a team of practitioners including the unit manager, the nurses and diet aides at the nursing home. The trained person giving the lecture is a researcher and dietician. Receives: Other: A three hour lecture about the guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Nutritional status is assessed with the Mini Nutritional Assessment-Short Form tool
Measured: 2 years
Secondary outcomes (3)
Functional status
Functional status is assessed with ADL (Activities in Daily Living) Barthel index.
Measured: 2 years
Cognitive status
Cognitive status is assessed with Short Portable Mental Status Questionnaire (SPMSQ).
Measured: 2 years
Health-related Quality of Life
Health-related Quality of Life is assessed with EQ-5D.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMay 2009
- Primary completionJun 2011
- Study completionJun 2011
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 Implementation StrategiesStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tommy Cederholm, Prof, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01861366
- Sponsor's protocol ID
- MuMs07
- Status last verified
- May 2013
- First submitted
- 21 May 2013
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Torma J, Winblad U, Saletti A, Cederholm T. Strategies to implement community guidelines on nutrition and their long-term clinical effects in nursing home residents. J Nutr Health Aging. 2015 Jan;19(1):70-6. doi: 10.1007/s12603-014-0522-4.
PubMed 25560819
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome in Nursing Home Residents After Implementation of Nutritional Guidelines
- ClinicalTrials.gov ID
- NCT01861366
- Acronym / sponsor ID
- MuMs07
- Keywords
- Implementation, Guidelines, Nutrition, Nursing home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 May 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 of this study is to examine two implementation strategies (external facilitation and educational outreach visit) when introducing nutritional guidelines in the elderly care setting and to evaluate the results of the implementation by clinical outcome measures of the nursing home residents.
The hypothesis is that the residents affected by the external facilitation strategy will stay stable in the measured clinical outcomes, while the residents influenced by the educational outreach visit will deteriorate during the implementation process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External facilitator | Experimental | Other: A one year multifaceted implementation strategyThe external facilitation is a one year multifaceted intervention, including support, guidance, practice audit and feedback, training targeted to a team of practitioners involving the unit manager, the nurses and diet aides at the nursing home. The facilitator is a researcher and dietician. |
| Educational outreach visit | Active comparator | Other: A three hour lecture about the guidelinesThe outreach visit is a three hour lecture about the nutritional guidelines targeted to a team of practitioners including the unit manager, the nurses and diet aides at the nursing home. The trained person giving the lecture is a researcher and dietician. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age of 65 or older
- nursing home resident
- persons who manage the examination methods (interviews and blood samples)
Key exclusion criteria (1 listed)
- persons in terminal stage of life
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 |
|---|---|---|
| A one year multifaceted implementation strategy | Other | External facilitator |
| A three hour lecture about the guidelines | Other | Educational outreach visit |
Primary outcome
Nutritional status
Time frame: 2 years
Nutritional status is assessed with the Mini Nutritional Assessment-Short Form tool
3 secondary outcomes
Functional status
Time frame: 2 years
Cognitive status
Time frame: 2 years
Health-related Quality of Life
Time frame: 2 years
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 23 May 2013.
- Derived from this study: PubMed 25560819Torma J, Winblad U, Saletti A, Cederholm T. Strategies to implement community guidelines on nutrition and their long-term clinical effects in nursing home residents. J Nutr Health Aging. 2015 Jan;19(1):70-6. doi: 10.1007/s12603-014-0522-4.
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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.
Tommy Cederholm, Prof principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A one year multifaceted implementation strategy and A three hour lecture about the guidelines in people with Implementation Strategies and Nutritional Outcome of Nursing Home Residents, run by Uppsala University at 1 site in Sweden.
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 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 23 May 2013. 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 Sweden. 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.
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?
Nutritional status (time frame: 2 years). 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 NCT01861366, 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 23 May 2013.