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Pain Management and Behavioral Outcomes in Patients With Dementia

Primary Purpose

Dementia, Alzheimer Disease, Pain, Behavior, Agitation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
acetaminophen 650 mg qid and placebo qid PRN. The other arm was placebo qid and acetaminophen 650 mg qid PRN
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must be: 55 years old and older, nursing home residents, a diagnosed painful that would respond to tylenol, documented agitated behavior, a dementia diagnosis or a functional impairment severe enough to rate a 7 on the Global Deterioration Scale, be unable to report pain. Patients must have been residents in the nursing home for at least 1 month with a plan to stay at least 2 months. Exclusion Criteria:

Sites / Locations

  • VA Palo Alto Health Care System, Palo Alto, CA

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 14, 2001
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00012857
Brief Title
Pain Management and Behavioral Outcomes in Patients With Dementia
Official Title
Pain Management and Behavioral Outcomes in Patients With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Dementia illness often co-exists with painful medical conditions associated with aging (e.g., degenerative joint disease, osteoarthritis, skin ulcers, back pain, headaches, cancer, or angina). While the standard practice is pain assessment for all patients, the elderly with dementia have special needs for assessment, management, and evaluation. When they are unable to verbalize pain, objective measurement of their discomfort are possible manifestations of pain. No research relates systemic pain treatment with reduction of negative problematic behaviors in patient dementia.
Detailed Description
Background: Dementia illness often co-exists with painful medical conditions associated with aging (e.g., degenerative joint disease, osteoarthritis, skin ulcers, back pain, headaches, cancer, or angina). While the standard practice is pain assessment for all patients, the elderly with dementia have special needs for assessment, management, and evaluation. When they are unable to verbalize pain, objective measurement of their discomfort are possible manifestations of pain. No research relates systemic pain treatment with reduction of negative problematic behaviors in patient dementia. Objectives: The objectives of this research are (1) to elucidate the relationships between pain, discomfort, and agitation; and (2) to determine the influence that pain management has on decreasing the outcomes of discomfort, agitation, and confusion in nursing home residents. Methods: This study used a randomized, double-blind, placebo-controlled, cross-over design. Each treatment arm lasted two weeks. The crossover point occurred without washout. One arm was acetaminophen 650 mg qid and placebo qid PRN. The other arm was placebo qid and acetaminophen 650 mg qid PRN. Sites involved in the study included the Jewish Home for the Aged in San Francisco; Golden Gate Healthcare Center in San Francisco; Palo Alto VA Health Care System; Nursing Home Care Unit at Livermore. Patients were included who: are > 55 years; have severe dementia; have a documented painful condition not requiring opiates or a current medication regimen; unable to report pain consistently or reliably; be present and accept treatment for study duration; have > 1 episode of agitation per day. Patients with schizophrenia or severe Parkinson�s are excluded. A research assistant (blind to treatment arm) tested each patient for discomfort, agitation, and confusion at baseline and two times per day on two days of the week for four weeks. Nurses rated patients for agitation each shift. Instruments included the Cohen-Mansfield Agitation Inventory, the Discomfort Scale, and the Confusion Assessment Method. Repeated measures analyses examined effect of treatment on the three behaviors (agitation, confusion, and discomfort). Status: The study is complete. Final report was submitted to HSR&D in August 2001.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease, Pain, Behavior, Agitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
acetaminophen 650 mg qid and placebo qid PRN. The other arm was placebo qid and acetaminophen 650 mg qid PRN

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be: 55 years old and older, nursing home residents, a diagnosed painful that would respond to tylenol, documented agitated behavior, a dementia diagnosis or a functional impairment severe enough to rate a 7 on the Global Deterioration Scale, be unable to report pain. Patients must have been residents in the nursing home for at least 1 month with a plan to stay at least 2 months. Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn K. Douglas, DNSc RN FAAN
Organizational Affiliation
VA Palo Alto Health Care System, Palo Alto, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pain Management and Behavioral Outcomes in Patients With Dementia

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