Testing the Effectiveness of Telephone Support for Dementia Caregivers

NCT00119561 | Completed

• 1 other identifier: IIR 03-287
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of the study is documentation of effectiveness of telephone support groups to reduce caregiver burden and stress. Caregivers who participate in intervention (Telephone Support) should experience lower levels of stress, burden and health care utilization (lower use of psychotropic drugs, fewer scheduled/unscheduled medical visits, lower rates of institutionalization, more efficient use of time in managing care recipient problems) compared to those caregivers in Usual Care.

Conditions

Dementia; Alzheimer Disease

Keywords

Caregiver; Dementia; Alzheimer Disease; Telephone; Randomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

• General well-being (revised Rand General Well-Being Scale); and caregiver's level of distress with care recipient behaviors (Revised Memory and Behavior Problems Checklist). Data is collected at baseline, 6 and 12 months in a face to face interview.

  6 and 12 months

Secondary Outcomes (2)

• Cost-Effectiveness

  6 and 12 months

• Time spent providing care

  6 and 12 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Telephone support groups

Behavioral: Telephone Support

Arm 2

NO INTERVENTION

Usual VA care

Interventions

Telephone Support BEHAVIORAL

Each telephone support group of 5 caregivers and a group leader met 14 times over a year. The hour calls were semi-structured with an educational component and a support component, led by a trained Group Leader. Topics included knowledge of dementia, safety, caregiver health and well being, communication, managing behavioral challenges and caregiver stress and coping.

Arm 1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregiver
• Age: 21 years or older
• Family member of the care recipient
• Must live with care recipient or share cooking facilities
• Must have a telephone
• Must plan to remain in the area for the duration of the intervention and follow-up
• Caregiver role for more than 6 months
• Must provide an average of 4 hours of supervision or direct assistance per day for the care recipient
• Risk Screening Tool: must have a total score of at least 1 for question 36, and a total of at least 2 for questions 38-40 (on the Screening Form)
• Care Recipient
• NINCDS (MD diagnosis) or cognitive impairment (raw score on MMSE of 23 or less)
• Must be a Veteran with dementia or being cared for by a Veteran who receives services at the Memphis VAMC

You may not qualify if:

• Caregiver
• Active treatment (chemotherapy; radiation therapy) for cancer
• Imminent placement of care recipient into a nursing home (within 6 months)
• SPMSQ: \> 4 errors
• Care Recipient
• History of Parkinson's Disease or a stroke with no reported decline in memory over the past year
• Active treatment (chemotherapy or radiation therapy) for cancer
• More than three acute medical hospitalizations in the past year (other than psychiatric or Alzheimer's Disease related admissions)
• Schizophrenia (onset of delusions before age 45) or other severe mental illness
• Dementia secondary to head trauma (probable)
• Blindness or deafness if either disability prohibits them from data collection or participation in the interventions
• MMSE = 0 and Bedbound (routinely confined to bed or chair for at least 22 hours a day, for at least 4 of the last 7 days)
• Planned nursing home admission in 6 months

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, 38104, United States

Location

Related Publications (2)

• Nichols LO, Martindale-Adams JL, Burns R, Graney MJ, Zuber JK, Kennedy SE. Potential explanations for control group benefit. Clin Trials. 2012 Oct;9(5):588-95. doi: 10.1177/1740774512455876. Epub 2012 Aug 23.

  PMID: 22917945 RESULT

• Martindale-Adams J, Nichols LO, Burns R, Graney MJ, Zuber J. A trial of dementia caregiver telephone support. Can J Nurs Res. 2013 Dec;45(4):30-48. doi: 10.1177/084456211304500404.

  PMID: 24617278 RESULT

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Linda Olivia Nichols, PhD

  Memphis VA Medical Center, Memphis, TN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2005
• First Posted: July 13, 2005
• Study Start: February 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: January 1, 2014
• Last Updated: April 7, 2015

Record last verified: 2014-07

Locations

US (1)