DementiaNCT01113749
Improving Decision Making About Feeding Options for Dementia
A study testing Feeding Options in Dementia Decision Aid in people with Dementia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Feeding Options in Dementia Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jun 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Older adult
Who may be able to join
- dementia diagnosis
- advanced cognitive impairment
- feeding problem
- age >= 65
- surrogate decision maker
Who cannot join
- feeding tube decision made
- hospice
- BMI > 26
- major psychosis or developmental delay
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
This study is a randomized trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.
Read the detailed description
This research study is a cluster randomized controlled trial of a decision aid to improve decision-making about feeding options for patients with advanced dementia. Surrogate decision-makers in the nursing homes randomized to the intervention will review the decision aid and be prompted to discuss it with the primary health care provider, while those in the control sites receive usual care. We measure the immediate, 1 and 3 month effects of the decision aid on the quality of surrogate decision-making for nursing home residents with advanced dementia.
- Conditions
- Dementia
- Being tested
- Feeding Options in Dementia Decision Aid
- Keywords
- Dementia, Nutrition, Feeding
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding Options in Dementia Decision AidOther
Structured decision aid on feeding options in dementia care with prompting to share information in discussion with primary treating health care provider.
| Study group | Role | What they receive |
|---|---|---|
| Decision support | Experimental | Structured decision aid with prompting to share information in discussion with primary treating health care providers. Receives: Other: Feeding Options in Dementia Decision Aid |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale
Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.
Measured: 3 months
Secondary outcomes (1)
Percent With Treatment Decisions
Treatment decisions are expressed as percentage of subjects with discussions of new tube feeding, new orders to forego tube feeding, and new choices for assisted feeding.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startMay 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Laura C Hanson, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113749
- Sponsor's protocol ID
- 05-3105
- Other IDs
- 5R01NR009826
- Status last verified
- Apr 2012
- First submitted
- 15 Apr 2010
- Last updated
- 4 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hanson LC, Ersek M, Lin FC, Carey TS. Outcomes of feeding problems in advanced dementia in a nursing home population. J Am Geriatr Soc. 2013 Oct;61(10):1692-7. doi: 10.1111/jgs.12448. Epub 2013 Sep 19.
PubMed 24083403Hanson LC, Carey TS, Caprio AJ, Lee TJ, Ersek M, Garrett J, Jackman A, Gilliam R, Wessell K, Mitchell SL. Improving decision-making for feeding options in advanced dementia: a randomized, controlled trial. J Am Geriatr Soc. 2011 Nov;59(11):2009-16. doi: 10.1111/j.1532-5415.2011.03629.x. Epub 2011 Sep 15.
PubMed 22091750Hanson LC, Gilliam R, Lee TJ. Successful clinical trial research in nursing homes: the Improving Decision-Making Study. Clin Trials. 2010 Dec;7(6):735-43. doi: 10.1177/1740774510380241. Epub 2010 Aug 20.
PubMed 20729251
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Decision Making About Feeding Options for Dementia
- ClinicalTrials.gov ID
- NCT01113749
- Acronym / sponsor ID
- 05-3105
- Conditions
- Dementia
- Keywords
- Dementia, Nutrition, Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- May 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 30 Apr 2010 (estimated)
- Results
- Posted 10 Aug 2012
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 trial to test whether a decision aid can help to improve the quality of decision making about feeding options in care of patients with dementia.
Detailed description
This research study is a cluster randomized controlled trial of a decision aid to improve decision-making about feeding options for patients with advanced dementia. Surrogate decision-makers in the nursing homes randomized to the intervention will review the decision aid and be prompted to discuss it with the primary health care provider, while those in the control sites receive usual care. We measure the immediate, 1 and 3 month effects of the decision aid on the quality of surrogate decision-making for nursing home residents with advanced dementia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision support | Experimental | Other: Feeding Options in Dementia Decision AidStructured decision aid with prompting to share information in discussion with primary treating health care providers. |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- dementia diagnosis
- advanced cognitive impairment
- feeding problem
- age >= 65
- surrogate decision maker
Key exclusion criteria (4 listed)
- feeding tube decision made
- hospice
- BMI > 26
- major psychosis or developmental delay
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 |
|---|---|---|
| Feeding Options in Dementia Decision AidStructured decision aid on feeding options in dementia care with prompting to share information in discussion with primary treating health care provider. | Other | Decision support |
Primary outcome
Decisional Conflict Scale
Time frame: 3 months
Decisional Conflict Scale measures conflict in decisions Total scale range 1-5 with lower scores indicating less conflict.
1 secondary outcome
Percent With Treatment Decisions
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24083403Hanson LC, Ersek M, Lin FC, Carey TS. Outcomes of feeding problems in advanced dementia in a nursing home population. J Am Geriatr Soc. 2013 Oct;61(10):1692-7. doi: 10.1111/jgs.12448. Epub 2013 Sep 19.
- Derived from this study: PubMed 22091750Hanson LC, Carey TS, Caprio AJ, Lee TJ, Ersek M, Garrett J, Jackman A, Gilliam R, Wessell K, Mitchell SL. Improving decision-making for feeding options in advanced dementia: a randomized, controlled trial. J Am Geriatr Soc. 2011 Nov;59(11):2009-16. doi: 10.1111/j.1532-5415.2011.03629.x. Epub 2011 Sep 15.
- Derived from this study: PubMed 20729251Hanson LC, Gilliam R, Lee TJ. Successful clinical trial research in nursing homes: the Improving Decision-Making Study. Clin Trials. 2010 Dec;7(6):735-43. doi: 10.1177/1740774510380241. Epub 2010 Aug 20.
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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.
Laura C Hanson, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding Options in Dementia Decision Aid in people with Dementia, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 5 inclusion and 4 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 4 Oct 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Decisional Conflict Scale (time frame: 3 months). 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 NCT01113749, which also lists 3 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 4 Oct 2023.