Care-resistant BehaviorNCT01363258
Reducing Care-Resistant Behaviors During Oral Hygiene in Persons With Dementia
A study testing Care-resistant mouth care (MOUTh) and Evidence-based mouth care in people with Care-resistant Behavior and Dementia, run by University of Alabama at Birmingham at 4 sites in United States.
Trial summary
The main purpose of this study is to test a method of providing mouth care to persons with dementia who live in nursing homes. The method of providing mouth care is designed to reduce fear in persons with dementia, so that these persons do not resist mouth care. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Care-resistant Behavior, Dementia
- What is being tested?
- Care-resistant mouth care (MOUTh) and Evidence-based mouth care
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2011to Nov 2015
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- age 55 or older
- documented diagnosis of dementia, Alzheimer's disease, vascular dementia, or Lewy body dementia
- identified by NH staff as resistant to mouth care
- at least 2 adjacent teeth AND/OR daily wearing of at least one denture plate
- the ability to hold a toothbrush
- the ability to move his or her hand to his or her mouth.
Who cannot join
- age less than 55
- no documented diagnosis of dementia
- inability to hold a toothbrush
- inability to raise his or her hand to his or her mouth
- receiving treatment for an active dental or denture problem
- a diagnosis of dysphagia requiring thickened liquids
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Centre Crest
Bellefonte, Pennsylvania, 16823
Spring Creek Rehabilitation &Health Care Center
Harrisburg, Pennsylvania, 17111
Rest Haven Rehabilitation &Nursing Center
York, Pennsylvania, 17043
Pleasant Acres Nursing &Rehabilitation Center
York, Pennsylvania, 17402
About this study
The main purpose of this study is to test a method of providing mouth care to persons with dementia who live in nursing homes. The method of providing mouth care is designed to reduce fear in persons with dementia, so that these persons do not resist mouth care.
Read the detailed description
Nursing home (NH) residents with dementia are often dependent on others for mouth care, yet will react with care-resistant behavior (CRB) when receiving assistance. The oral health of these elders deteriorates in the absence of daily oral hygiene, predisposing them to harmful systemic problems such as pneumonia, hyperglycemia, cardiac disease, and cerebral vascular accidents. The purpose of this study is to determine whether CRBs can be reduced, and oral health improved, through the application of an intervention based on the neurobiological principles of threat perception and fear response. When faced with a threat, all organisms react with "flight-fight" responses. These responses are both autonomic (e.g. elevated heart rate, sweating) and behavioral (e.g. moving away, attacking). Persons with dementia have heightened threat perception as a result of neurobiological changes that affect the cerebral cortex, hippocampus, and amygdala. These individuals may interpret mouth care as a threatening action by threatening people. The intervention, called Managing Oral Hygiene Using Threat Reduction (MOUTh), combines best mouth care practices with a constellation of behavioral techniques that reduce threat perception and thereby prevent or de-escalate CRB. The primary specific aims of the study are to: 1)Evaluate the efficacy of the MOUTh intervention for reducing CRBs in persons with dementia; 2)Validate the overall efficacy of the MOUTh intervention using nurse-sensitive oral health outcomes--swollen and bleeding gums, cleanliness of the oral cavity, saliva, and integrity of the lips and oral mucosa; and 3)Calculate the cost of the MOUTh intervention. Using a randomized repeated measures design, 80 elders with dementia from 5 different NHs will be randomized at the individual level to the experimental group, which will receive the intervention, or to the control group, which will receive standard mouth care from research team members who receive training in the proper methods for providing mouth care but no training in resistance recognition or prevention/mediation. Oral health assessments and CRB measurements will be obtained during a 7-day observation period and a 21-day intervention period. Individual growth models using multilevel analysis will be used to estimate the efficacy of the intervention for reducing CRBs in persons with dementia, and to estimate the overall efficacy of the intervention using oral health outcomes. Activity-based costing methods will be used to determine the cost of the MOUTh intervention. At the end of this study, the research team anticipates having a proven intervention that prevents and reduces CRB within the context of mouth care. Long-term objectives include testing the effect of the intervention on systemic illnesses among persons with dementia; examining the transferability of this intervention to other activities of daily living; and disseminating threat reduction interventions to NH staff, which may radically change the way care is provided to persons with dementia.
- Conditions
- Care-resistant Behavior, Dementia
- Being tested
- Care-resistant mouth care (MOUTh), Evidence-based mouth care
- Keywords
- Elderly, Dementia, Care-resistant behavior, Oral health, Long-term care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care-resistant mouth care (MOUTh)Behavioural
The intervention combines best mouth care practices with a constellation of behavioral techniques that reduce threat perception and thereby prevent or de-escalate care-resistant behavior.
Evidence-based mouth careProcedure or surgery
Mouth care tailored to the needs of older adults, including care of dentures.
| Study group | Role | What they receive |
|---|---|---|
| Care-resistant mouth care (MOUTh) | Experimental | These nursing home residents with dementia receive mouth care from study personnel who use strategies to reduce care-resistant behavior (Managing Oral Hygiene Using Threat Reduction or MOUTh) while providing evidence-based mouth care. Receives: Behavioral: Care-resistant mouth care (MOUTh) |
| Evidence Base Mouth Care | Active comparator | Nursing home residents with dementia received mouth care from study personnel who were trained in evidence-based mouth care only. Receives: Procedure: Evidence-based mouth care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care-Resistant Behavior
Care-resistant behavior will be measured using the Resistiveness to Care Scale.This instrument is a checklist. The 13 care-resistant behaviors (e.g., turn away, hit/kick, say "no", etc.) are listed on the left side of the instrument. There are 3 columns for each behavior (mild, moderate, and severe). When behaviors occur, a tick mark is placed in the appropriate column (mild, moderate, or severe). The final score is obtained by multiplying the sums for mild by 1, the sums for moderate by 2, and the sums for severe behavior by 3. These subtotals are then summed together for a final care-resistant behavior score. One cannot determine the frequency and quality of behaviors from raw scores alone. For example, a score of 12 could mean 12 "mild" behaviors or 4 "severe" behaviors. The sums were used as global care-resistant behavior. Higher numbers signify more frequent and intense care-resistant behavior. Minimum value was 0, max value was 25.
Measured: Baseline (observation) to follow-up (week 3)
Secondary outcomes (1)
Oral Health
The oral health will be measured as the total score obtained from the Oral Health Assessment Tool. The OHAT contains 8 categories (e.g., status of gums, dentition, moisture of oral cavity, general cleanliness, etc.). Each category is assigned a value of 0=healthy, 1=problematic, and 2=unhealthy. Scores range from 0 (healthy) to 16 (unhealthy).
Measured: Baseline (observation) to follow-up (week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2015
- Study completionNov 2015
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 (2)Papers the sponsor has linked to this study.
- Other trials for Care-resistant BehaviorStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita A. Jablonski, University of Alabama at Birmingham
- Investigators
- Rita A Jablonski-Jaudon, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363258
- Sponsor's protocol ID
- R01NR012737
- Status last verified
- May 2018
- First submitted
- 27 May 2011
- Last updated
- 7 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jablonski RA, Therrien B, Mahoney EK, Kolanowski A, Gabello M, Brock A. An intervention to reduce care-resistant behavior in persons with dementia during oral hygiene: a pilot study. Spec Care Dentist. 2011 May-Jun;31(3):77-87. doi: 10.1111/j.1754-4505.2011.00190.x.
PubMed 21592161Jablonski RA, Kolanowski A, Therrien B, Mahoney EK, Kassab C, Leslie DL. Reducing care-resistant behaviors during oral hygiene in persons with dementia. BMC Oral Health. 2011 Nov 19;11:30. doi: 10.1186/1472-6831-11-30.
PubMed 22100010
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Care-Resistant Behaviors During Oral Hygiene in Persons With Dementia
- ClinicalTrials.gov ID
- NCT01363258
- Acronym / sponsor ID
- R01NR012737
- Conditions
- Care-resistant Behavior, Dementia
- Keywords
- Elderly, Dementia, Care-resistant behavior, Oral health, Long-term care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Posted 7 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to test a method of providing mouth care to persons with dementia who live in nursing homes. The method of providing mouth care is designed to reduce fear in persons with dementia, so that these persons do not resist mouth care.
Detailed description
Nursing home (NH) residents with dementia are often dependent on others for mouth care, yet will react with care-resistant behavior (CRB) when receiving assistance. The oral health of these elders deteriorates in the absence of daily oral hygiene, predisposing them to harmful systemic problems such as pneumonia, hyperglycemia, cardiac disease, and cerebral vascular accidents. The purpose of this study is to determine whether CRBs can be reduced, and oral health improved, through the application of an intervention based on the neurobiological principles of threat perception and fear response. When faced with a threat, all organisms react with "flight-fight" responses. These responses are both autonomic (e.g. elevated heart rate, sweating) and behavioral (e.g. moving away, attacking). Persons with dementia have heightened threat perception as a result of neurobiological changes that affect the cerebral cortex, hippocampus, and amygdala. These individuals may interpret mouth care as a threatening action by threatening people. The intervention, called Managing Oral Hygiene Using Threat Reduction (MOUTh), combines best mouth care practices with a constellation of behavioral techniques that reduce threat perception and thereby prevent or de-escalate CRB. The primary specific aims of the study are to: 1)Evaluate the efficacy of the MOUTh intervention for reducing CRBs in persons with dementia; 2)Validate the overall efficacy of the MOUTh intervention using nurse-sensitive oral health outcomes--swollen and bleeding gums, cleanliness of the oral cavity, saliva, and integrity of the lips and oral mucosa; and 3)Calculate the cost of the MOUTh intervention. Using a randomized repeated measures design, 80 elders with dementia from 5 different NHs will be randomized at the individual level to the experimental group, which will receive the intervention, or to the control group, which will receive standard mouth care from research team members who receive training in the proper methods for providing mouth care but no training in resistance recognition or prevention/mediation. Oral health assessments and CRB measurements will be obtained during a 7-day observation period and a 21-day intervention period. Individual growth models using multilevel analysis will be used to estimate the efficacy of the intervention for reducing CRBs in persons with dementia, and to estimate the overall efficacy of the intervention using oral health outcomes. Activity-based costing methods will be used to determine the cost of the MOUTh intervention. At the end of this study, the research team anticipates having a proven intervention that prevents and reduces CRB within the context of mouth care. Long-term objectives include testing the effect of the intervention on systemic illnesses among persons with dementia; examining the transferability of this intervention to other activities of daily living; and disseminating threat reduction interventions to NH staff, which may radically change the way care is provided to persons with dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care-resistant mouth care (MOUTh) | Experimental | Behavioral: Care-resistant mouth care (MOUTh)These nursing home residents with dementia receive mouth care from study personnel who use strategies to reduce care-resistant behavior (Managing Oral Hygiene Using Threat Reduction or MOUTh) while providing evidence-based mouth care. |
| Evidence Base Mouth Care | Active comparator | Procedure: Evidence-based mouth careNursing home residents with dementia received mouth care from study personnel who were trained in evidence-based mouth care only. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English-speaking
- age 55 or older
- documented diagnosis of dementia, Alzheimer's disease, vascular dementia, or Lewy body dementia
- identified by NH staff as resistant to mouth care
- at least 2 adjacent teeth AND/OR daily wearing of at least one denture plate
Key exclusion criteria (6 listed)
- age less than 55
- no documented diagnosis of dementia
- inability to hold a toothbrush
- inability to raise his or her hand to his or her mouth
- receiving treatment for an active dental or denture problem
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 |
|---|---|---|
| Care-resistant mouth care (MOUTh)The intervention combines best mouth care practices with a constellation of behavioral techniques that reduce threat perception and thereby prevent or de-escalate care-resistant behavior. | Behavioural | Care-resistant mouth care (MOUTh) |
| Evidence-based mouth careMouth care tailored to the needs of older adults, including care of dentures. | Procedure or surgery | Evidence Base Mouth Care |
Primary outcome
Care-Resistant Behavior
Time frame: Baseline (observation) to follow-up (week 3)
Care-resistant behavior will be measured using the Resistiveness to Care Scale.This instrument is a checklist. The 13 care-resistant behaviors (e.g., turn away, hit/kick, say "no", etc.) are listed on the left side of the instrument. There are 3 columns for each behavior (mild, moderate, and severe). When behaviors occur, a tick mark is placed in the appropriate column (mild, moderate, or severe). The final score is obtained by multiplying the sums for mild by 1, the sums for moderate by 2, and the sums for severe behavior by 3. These subtotals are then summed together for a final care-resistant behavior score. One cannot determine the frequency and quality of behaviors from raw scores alone. For example, a score of 12 could mean 12 "mild" behaviors or 4 "severe" behaviors. The sums were used as global care-resistant behavior. Higher numbers signify more frequent and intense care-resistant behavior. Minimum value was 0, max value was 25.
1 secondary outcome
Oral Health
Time frame: Baseline (observation) to follow-up (week 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21592161Jablonski RA, Therrien B, Mahoney EK, Kolanowski A, Gabello M, Brock A. An intervention to reduce care-resistant behavior in persons with dementia during oral hygiene: a pilot study. Spec Care Dentist. 2011 May-Jun;31(3):77-87. doi: 10.1111/j.1754-4505.2011.00190.x.
- Derived from this study: PubMed 22100010Jablonski RA, Kolanowski A, Therrien B, Mahoney EK, Kassab C, Leslie DL. Reducing care-resistant behaviors during oral hygiene in persons with dementia. BMC Oral Health. 2011 Nov 19;11:30. doi: 10.1186/1472-6831-11-30.
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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.
Rita A Jablonski-Jaudon, PhD principal investigator
University of Alabama at Birmingham
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care-resistant mouth care (MOUTh) and Evidence-based mouth care in people with Care-resistant Behavior and Dementia, run by University of Alabama at Birmingham at 4 sites 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 7 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: finished, as of the sponsor's last update on 7 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 7 Jun 2018). 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?
Care-Resistant Behavior (time frame: Baseline (observation) to follow-up (week 3)). 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 NCT01363258, 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 7 Jun 2018.