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Bathing persons with Alzheimer's disease aT Home (The BATH Study) Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Bathing persons with Alzheimer's disease aT Home (The BATH Study) conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Bathing persons with Alzheimer's disease aT Home (The BATH Study) Clinical research trials and Bathing persons with Alzheimer's disease aT Home (The BATH Study) healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Bathing persons with Alzheimer's disease aT Home (The BATH Study). Bathing persons with Alzheimer's disease aT Home (The BATH Study) Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Bathing persons with Alzheimer's disease aT Home (The BATH Study) clinical trial. Test subjects typically receive the most effective healthcare possible for their Bathing persons with Alzheimer's disease aT Home (The BATH Study) condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Bathing persons with Alzheimer's disease aT Home (The BATH Study)  Bathing persons with Alzheimer's disease aT Home (The BATH Study)
Bathing persons with Alzheimer's disease aT Home (The BATH Study)
For Condition: Alzheimer Disease
Status: Recruiting
Sponsor(s): National Institute of Nursing Research (NINR) ,
Synopsis: 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 recipien
Details: 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.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 60 Years/
Genders: Both
Protocol Entry Criteria: Inclusion: - 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. - 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. Exclusion: - 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.
Total Enrollment: 100
Location and Contact Information:
Overall Study Official:
EllenMahoney, Principal Investigator, Boston College, William F. Connell School of Nursing
Boston College, William F. Connell School of Nursing *Recruiting*
Chestnut Hill, Massachusetts, 02467-3812
United States
Recruiting Scott Trudeau 866-576-4484
Additional Information:
Study ID Numbers: IA0044; RO1 NR07893-01A1
Study Start Date: September 2002
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062569
Other Alzheimer Disease Studies:
1. The Effect of Short-Term Statins and NSAIDs on Levels of Beta-Amyloid, a Protein Associated with Alzheimer's Disease
2. COGNIShunt® System for Alzheimer's Disease
3. The Safety and Efficacy of an Investigational Drug in Delaying the Progression of Alzheimer's Disease
4. Vitamin E in Aging Persons With Down Syndrome
5. Effectiveness of A Nutritional Brain Metabolic Enhancer for Alzheimer Disease
Related Studies:
Other Alzheimer Disease Clinical Trials
Other Massachusetts Clinical Trials
Other Chestnut Hill Clinical Trials
Bathing persons with Alzheimer's disease aT Home (The BATH Study)
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