Alzheimer DiseaseNCT00062569
Bathing Persons With Alzheimer's Disease aT Home (The BATH Study)
A study testing Bathing Support Intervention (BSI) and Caregiver reminiscence with coaching in people with Alzheimer Disease, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of a 3-week reminiscence intervention applied during bathing persons with Alzheimer's disease (AD) in decreasing resistiveness to care (RTC), relieving patient discomfort, and improving spouse caregiver appraisals of burden, capabilities and confidence while bathing the… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Bathing Support Intervention (BSI) and Caregiver reminiscence with coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Jun 2006
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of probable Alzheimer's disease or a related disorder according to standard criteria.
- Have functional dependence in bathing;
- Demonstrate resistiveness to care during bathing;
- Live in the community in a home setting (house, apartment, condominium);
- Have a primary caregiver spouse or partner who lives with the care recipient and agrees to be in the study; and
- Have no anticipated admission for long term care within 3 months.
Show all 9Show fewer
- Must be married couples or life partners living with Alzheimer's disease or related disorder living within a 15-mile radius of Boston College.
- Spouse or caregiver partner is the primary caregiver, including assistance with bathing.
- Women and minorities are encouraged to participate.
Who cannot join
- Severe concomitant medical conditions of patient or spouse.
- Not fluent in English.
- Couple resides in an institutional setting.
- Couple anticipates a significant change of living situation within three months.
- Couple does not meet the above inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston College, William F. Connell School of Nursing
Chestnut Hill, Massachusetts, 02467-3812
About this study
Official title: Reminiscence During Bathing Persons With Alzheimer's Disease at Home
This study will evaluate the effectiveness of a 3-week reminiscence intervention applied during bathing persons with Alzheimer's disease (AD) in decreasing resistiveness to care (RTC), relieving patient discomfort, and improving spouse caregiver appraisals of burden, capabilities and confidence while bathing the patient. Reminiscence provides opportunities for the patient to feel good and recall pleasant memories, easily done by caregivers in a home setting. Home visits and telephone calls from trained nurses provide coaching and practice for caregivers for the preliminary phase of this study. Each couple will be enrolled in the study for approximately 9 weeks. The study will recruit 100 patient/spouse caregiver couples randomly divided into one of two groups: reminiscence with coaching, or bathing support (control). Bathing support will be provided to participants in both conditions including: individualized assessment; education regarding bathing techniques for people with dementia; and individualized problem solving. In addition to the bathing support intervention, participants in the experimental group will receive a pleasant memories interview and reminiscence script with coaching for implementation. Caregivers will keep a journal of their experiences in bathing the care recipient.
Read the detailed description
Bath time is often distressing to persons with Alzheimer's disease (AD), leading to behavioral symptoms of resistiveness to care. Encountering these behaviors is distressing for caregivers, as well. Most studies of intervention for behavioral symptoms of AD have been done in nursing homes, but most care takes place in the home. The overall goal of this research is to improve the at-home bathing experience of both patients with AD and their spouse caregivers. This study builds on preliminary studies that: 1) developed observational measures of patient behaviors, and 2) developed and pilot tested the reminiscence during bathing intervention.
This randomized clinical trial will evaluate the effectiveness of a 3-week reminiscence intervention, applied during bathing persons with AD, in decreasing resistiveness to care (RTC), relieving patient discomfort, and improving spouse caregiver appraisals of burden, self-efficacy with bathing, and satisfaction. Reminiscence provides an intervention that draws on preserved individuality and memories, easily implemented by caregivers in a home setting. Home visits and telephone calls provide coaching and practice for caregivers in implementation. The sample includes 100 patient/spouse caregiver couples, randomized into one of two groups: reminiscence with coaching or bathing support (control).
Bathing support will be provided to participants in both conditions including: individualized assessment; education regarding bathing techniques for people with dementia; and individualized problem solving. In addition to the bathing support intervention, participants in the experimental group will receive a pleasant memories interview and reminiscence script with coaching for implementation. Using repeated measures design, observations will be made at baseline, post-intervention (5 weeks), and follow-up (8 weeks).
In the coaching/practicing/support phase of the study, caregivers will receive 1-hour home visits by a Nurse Interventionist (NI) for two weeks with caregiver practice and telephone support in between the in-home coaching/support visits. During the home visits, the NI will: (a) review the written reminiscence script and "crib sheet" with the spouse and role-model its use, (b) discuss instructions for delivering the reminiscence intervention to the patient immediately prior to and during the bath/shower, (c) teach the spouse to record patient behavior and intervention intensity using visual analog scales, and (d) review general approaches to bathing including a calm, unhurried approach, smiling, eye contact, brief description of what to expect, simple directions with time for the patient to respond, encourage patient participation, try not to respond to negative behaviors, praise for positive behaviors. Spouse caregivers will be encouraged to practice using the reminiscence intervention with every bath/shower for a 2-week period and to record the frequency of program implementation throughout the week on the data sheets.
- Conditions
- Alzheimer Disease
- Being tested
- Bathing Support Intervention (BSI), Caregiver reminiscence with coaching
- Keywords
- Alzheimer disease, Resistiveness to baths, Caregiver stress, Bathing support intervention, Reminiscence, Agitated behavior, Resistiveness to care
- Medical subject headings
- Alzheimer Disease, Caregiver Burden, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bathing Support Intervention (BSI)Behavioural
Bathing Support Intervention - Review of caregiver current practices and perceptions and care recipient behavioral symptoms associated with bathing with pattern analysis based on observation; skill building for bathing and communication techniques; coaching for implementation
Caregiver reminiscence with coachingBehavioural
BSI plus Reminiscence - BSI as above plus caregiver interview to ascertain pleasant long-term memories (e.g. stories, pictures, music) developed into a "crib sheet" for caregiver use conversationally prior to and during the bath
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Bathing Support Intervention (BSI) |
| 2 | Experimental | Not described Receives: Behavioral: Caregiver reminiscence with coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care Recipient: Resistiveness to care; discomfort
Measured: Baseline, post 3-week intervention, and 3-week follow-up.
Caregiver: Self-efficacy; interactive behaviors
Measured: Baseline, post 3-week intervention, and 3-week follow-up.
Secondary outcomes (1)
Caregiver burden & satisfaction
Measured: Baseline, post 3-week intervention, and 3-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2003 (estimated)
- Study startSep 2002
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Investigators
- Ellen K. Mahoney, DNS, RN, Principal investigator, Boston College, William F. Connell School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00062569
- Sponsor's protocol ID
- IA0044
- Other IDs
- R01NR007893-01A1
- Status last verified
- Mar 2009
- First submitted
- 9 Jun 2003
- Last updated
- 12 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Mahoney EK, Hurley AC, Volicer L, Bell M, Gianotis P, Hartshorn M, Lane P, Lesperance R, MacDonald S, Novakoff L, Rheaume Y, Timms R, Warden V. Development and testing of the Resistiveness to Care Scale. Res Nurs Health. 1999 Feb;22(1):27-38. doi: 10.1002/(sici)1098-240x(199902)22:13.0.co;2-t.
PubMed 9928961Moss SE, Polignano E, White CL, Minichiello MD, Sunderland T. Reminiscence group activities and discourse interaction in Alzheimer's disease. J Gerontol Nurs. 2002 Aug;28(8):36-44. doi: 10.3928/0098-9134-20020801-09.
PubMed 12219552Mahoney E, Volicer L, Hurley A. (2000). Managing Challenging Behaviors in Persons with Dementia. Baltimore, MD: Health Professions Press.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reminiscence During Bathing Persons With Alzheimer's Disease at Home
- ClinicalTrials.gov ID
- NCT00062569
- Acronym / sponsor ID
- IA0044
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease, Resistiveness to baths, Caregiver stress, Bathing support intervention, Reminiscence, Agitated behavior, Resistiveness to care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- Sep 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 12 Jun 2003 (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.
This study will evaluate the effectiveness of a 3-week reminiscence intervention applied during bathing persons with Alzheimer's disease (AD) in decreasing resistiveness to care (RTC), relieving patient discomfort, and improving spouse caregiver appraisals of burden, capabilities and confidence while bathing the patient. Reminiscence provides opportunities for the patient to feel good and recall pleasant memories, easily done by caregivers in a home setting. Home visits and telephone calls from trained nurses provide coaching and practice for caregivers for the preliminary phase of this study. Each couple will be enrolled in the study for approximately 9 weeks. The study will recruit 100 patient/spouse caregiver couples randomly divided into one of two groups: reminiscence with coaching, or bathing support (control). Bathing support will be provided to participants in both conditions including: individualized assessment; education regarding bathing techniques for people with dementia; and individualized problem solving. In addition to the bathing support intervention, participants in the experimental group will receive a pleasant memories interview and reminiscence script with coaching for implementation. Caregivers will keep a journal of their experiences in bathing the care recipient.
Detailed description
Bath time is often distressing to persons with Alzheimer's disease (AD), leading to behavioral symptoms of resistiveness to care. Encountering these behaviors is distressing for caregivers, as well. Most studies of intervention for behavioral symptoms of AD have been done in nursing homes, but most care takes place in the home. The overall goal of this research is to improve the at-home bathing experience of both patients with AD and their spouse caregivers. This study builds on preliminary studies that: 1) developed observational measures of patient behaviors, and 2) developed and pilot tested the reminiscence during bathing intervention.
This randomized clinical trial will evaluate the effectiveness of a 3-week reminiscence intervention, applied during bathing persons with AD, in decreasing resistiveness to care (RTC), relieving patient discomfort, and improving spouse caregiver appraisals of burden, self-efficacy with bathing, and satisfaction. Reminiscence provides an intervention that draws on preserved individuality and memories, easily implemented by caregivers in a home setting. Home visits and telephone calls provide coaching and practice for caregivers in implementation. The sample includes 100 patient/spouse caregiver couples, randomized into one of two groups: reminiscence with coaching or bathing support (control).
Bathing support will be provided to participants in both conditions including: individualized assessment; education regarding bathing techniques for people with dementia; and individualized problem solving. In addition to the bathing support intervention, participants in the experimental group will receive a pleasant memories interview and reminiscence script with coaching for implementation. Using repeated measures design, observations will be made at baseline, post-intervention (5 weeks), and follow-up (8 weeks).
In the coaching/practicing/support phase of the study, caregivers will receive 1-hour home visits by a Nurse Interventionist (NI) for two weeks with caregiver practice and telephone support in between the in-home coaching/support visits. During the home visits, the NI will: (a) review the written reminiscence script and "crib sheet" with the spouse and role-model its use, (b) discuss instructions for delivering the reminiscence intervention to the patient immediately prior to and during the bath/shower, (c) teach the spouse to record patient behavior and intervention intensity using visual analog scales, and (d) review general approaches to bathing including a calm, unhurried approach, smiling, eye contact, brief description of what to expect, simple directions with time for the patient to respond, encourage patient participation, try not to respond to negative behaviors, praise for positive behaviors. Spouse caregivers will be encouraged to practice using the reminiscence intervention with every bath/shower for a 2-week period and to record the frequency of program implementation throughout the week on the data sheets.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Bathing Support Intervention (BSI) |
| 2 | Experimental | Behavioral: Caregiver reminiscence with coaching |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have a diagnosis of probable Alzheimer's disease or a related disorder according to standard criteria.
- Have functional dependence in bathing;
- Demonstrate resistiveness to care during bathing;
- Live in the community in a home setting (house, apartment, condominium);
- Have a primary caregiver spouse or partner who lives with the care recipient and agrees to be in the study; and
Key exclusion criteria (5 listed)
- Severe concomitant medical conditions of patient or spouse.
- Not fluent in English.
- Couple resides in an institutional setting.
- Couple anticipates a significant change of living situation within three months.
- Couple does not meet the above inclusion criteria.
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 |
|---|---|---|
| Bathing Support Intervention (BSI)Bathing Support Intervention - Review of caregiver current practices and perceptions and care recipient behavioral symptoms associated with bathing with pattern analysis based on observation; skill building for bathing and communication techniques; coaching for implementation | Behavioural | 1 |
| Caregiver reminiscence with coachingBSI plus Reminiscence - BSI as above plus caregiver interview to ascertain pleasant long-term memories (e.g. stories, pictures, music) developed into a "crib sheet" for caregiver use conversationally prior to and during the bath | Behavioural | 2 |
Primary outcome
Care Recipient: Resistiveness to care; discomfort
Time frame: Baseline, post 3-week intervention, and 3-week follow-up.
Caregiver: Self-efficacy; interactive behaviors
Time frame: Baseline, post 3-week intervention, and 3-week follow-up.
1 secondary outcome
Caregiver burden & satisfaction
Time frame: Baseline, post 3-week intervention, and 3-week follow-up.
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 12 Mar 2009.
- Background: PubMed 9928961Mahoney EK, Hurley AC, Volicer L, Bell M, Gianotis P, Hartshorn M, Lane P, Lesperance R, MacDonald S, Novakoff L, Rheaume Y, Timms R, Warden V. Development and testing of the Resistiveness to Care Scale. Res Nurs Health. 1999 Feb;22(1):27-38. doi: 10.1002/(sici)1098-240x(199902)22:13.0.co;2-t.
- Background: PubMed 12219552Moss SE, Polignano E, White CL, Minichiello MD, Sunderland T. Reminiscence group activities and discourse interaction in Alzheimer's disease. J Gerontol Nurs. 2002 Aug;28(8):36-44. doi: 10.3928/0098-9134-20020801-09.
- BackgroundMahoney E, Volicer L, Hurley A. (2000). Managing Challenging Behaviors in Persons with Dementia. Baltimore, MD: Health Professions Press.
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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.
Ellen K. Mahoney, DNS, RN principal investigator
Boston College, William F. Connell School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bathing Support Intervention (BSI) and Caregiver reminiscence with coaching in people with Alzheimer Disease, run by National Institute of Nursing Research (NINR) 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 9 inclusion and 5 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 12 Mar 2009. 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?
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?
Care Recipient: Resistiveness to care; discomfort (time frame: Baseline, post 3-week intervention, and 3-week follow-up.). The study lists 2 primary outcomes in all. 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 NCT00062569, 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 12 Mar 2009.