Viewing Study NCT00062569



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Study NCT ID: NCT00062569
Status: COMPLETED
Last Update Posted: 2009-03-12
First Post: 2003-06-09

Brief Title: Bathing Persons With Alzheimers Disease aT Home The BATH Study
Sponsor: National Institute of Nursing Research NINR
Organization: National Institute of Nursing Research NINR

Study Overview

Official Title: Reminiscence During Bathing Persons With Alzheimers Disease at Home
Status: COMPLETED
Status Verified Date: 2009-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will evaluate the effectiveness of a 3-week reminiscence intervention applied during bathing persons with Alzheimers 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 patientspouse 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 Alzheimers 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 patientspouse 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 coachingpracticingsupport 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 coachingsupport 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 bathshower 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 bathshower for a 2-week period and to record the frequency of program implementation throughout the week on the data sheets

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01NR007893-01A1 NIH None httpsreporternihgovquickSearchR01NR007893-01A1