NCT00062569

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Sep 2002

Typical duration for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

March 12, 2009

Status Verified

March 1, 2009

Enrollment Period

3.8 years

First QC Date

June 9, 2003

Last Update Submit

March 10, 2009

Conditions

Keywords

Alzheimer diseaseResistiveness to bathsCaregiver stressBathing support interventionReminiscenceAgitated behaviorResistiveness to care

Outcome Measures

Primary Outcomes (2)

  • Care Recipient: Resistiveness to care; discomfort

    Baseline, post 3-week intervention, and 3-week follow-up.

  • Caregiver: Self-efficacy; interactive behaviors

    Baseline, post 3-week intervention, and 3-week follow-up.

Secondary Outcomes (1)

  • Caregiver burden & satisfaction

    Baseline, post 3-week intervention, and 3-week follow-up.

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Bathing Support Intervention (BSI)

2

EXPERIMENTAL
Behavioral: Caregiver reminiscence with coaching

Interventions

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

1

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

2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston College, William F. Connell School of Nursing

Chestnut Hill, Massachusetts, 02467-3812, United States

Location

Related Publications (3)

  • 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.

    PMID: 9928961BACKGROUND
  • Moss 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.

    PMID: 12219552BACKGROUND
  • Mahoney E, Volicer L, Hurley A. (2000). Managing Challenging Behaviors in Persons with Dementia. Baltimore, MD: Health Professions Press.

    BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseCaregiver BurdenPsychomotor Agitation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehaviorDyskinesiasNeurologic ManifestationsPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in Dementia

Study Officials

  • Ellen K. Mahoney, DNS, RN

    Boston College, William F. Connell School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 9, 2003

First Posted

June 12, 2003

Study Start

September 1, 2002

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

March 12, 2009

Record last verified: 2009-03

Locations