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

March 10, 2009 updated by: National Institute of Nursing Research (NINR)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467-3812
        • Boston College, William F. Connell School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Care Recipient: Resistiveness to care; discomfort
Time Frame: Baseline, post 3-week intervention, and 3-week follow-up.
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.
Baseline, post 3-week intervention, and 3-week follow-up.

Secondary Outcome Measures

Outcome Measure
Time Frame
Caregiver burden & satisfaction
Time Frame: Baseline, post 3-week intervention, and 3-week follow-up.
Baseline, post 3-week intervention, and 3-week follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Ellen K. Mahoney, DNS, RN, Boston College, William F. Connell School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

June 9, 2003

First Submitted That Met QC Criteria

June 11, 2003

First Posted (Estimate)

June 12, 2003

Study Record Updates

Last Update Posted (Estimate)

March 12, 2009

Last Update Submitted That Met QC Criteria

March 10, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0044
  • R01NR007893-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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