Bathing Persons With Alzheimer's Disease aT Home (The BATH Study)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:
NCT00062569
First received: June 9, 2003
Last updated: March 10, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention
Alzheimer Disease
Behavioral: Bathing Support Intervention (BSI)
Behavioral: Caregiver reminiscence with coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Reminiscence During Bathing Persons With Alzheimer's Disease at Home

Resource links provided by NLM:


Further study details as provided by National Institute of Nursing Research (NINR):

Primary Outcome Measures:
  • Care Recipient: Resistiveness to care; discomfort [ Time Frame: Baseline, post 3-week intervention, and 3-week follow-up. ] [ Designated as safety issue: No ]
  • Caregiver: Self-efficacy; interactive behaviors [ Time Frame: Baseline, post 3-week intervention, and 3-week follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Caregiver burden & satisfaction [ Time Frame: Baseline, post 3-week intervention, and 3-week follow-up. ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: September 2002
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: 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
Experimental: 2 Behavioral: Caregiver reminiscence with coaching
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

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062569

Locations
United States, Massachusetts
Boston College, William F. Connell School of Nursing
Chestnut Hill, Massachusetts, United States, 02467-3812
Sponsors and Collaborators
Investigators
Principal Investigator: Ellen K. Mahoney, DNS, RN Boston College, William F. Connell School of Nursing
  More Information

Publications:
Responsible Party: Ellen K. Mahoney, Boston College
ClinicalTrials.gov Identifier: NCT00062569     History of Changes
Other Study ID Numbers: IA0044, RO1 NR07893-01A1
Study First Received: June 9, 2003
Last Updated: March 10, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Nursing Research (NINR):
Alzheimer disease
Resistiveness to baths
Caregiver stress
Bathing support intervention
Reminiscence
Agitated behavior
Resistiveness to care

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014