CClinicalTrials.gg
CompletedNCT00119561CONNECTUpdated Apr 7, 2015

Testing the Effectiveness of Telephone Support for Dementia Caregivers

An interventional study of Telephone Support in Dementia and Alzheimer Disease, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the detailed description

Background: Caregiving can severely limit caregivers' lives. In order to keep their family member at home, dementia caregivers often experience physical and psychological strain, social isolation, loss of time for self, and inability to obtain and/or afford assistance with caregiving tasks. The amount of time spent in providing care for a family member with dementia contributes to these problems. Dementia caregivers report spending around 18 hours per day in caregiving tasks and 3 hours per day in supervision. The high levels of stress involved in caring for a dementia patient and the widespread lack of training in such care can lead to a vicious cycle of ever-increasing health care dependency, first for the patient and secondly for informal caregivers. Telephone Support Groups have the potential to address caregivers' stress, isolation and education about dementia and its management, leading to sustainable informal caregiving and lower healthcare use and overall VHA expenditures for the veteran patient with dementia.

Objectives: Study objectives are to 1) examine Telephone Support Groups' effectiveness for caregivers, 2) determine whether Telephone Support results in decreases in VHA health care use and costs for the veteran, and decreased VHA and/or non-VHA use and costs for the caregiver, and 3) examine the intervention's effect on caregivers' time spent providing care. The long-term objective is to develop and disseminate the protocol and materials for effective Telephone Support Groups that can be used across the VHA system.

Methods: This randomized clinical trial of 154 caregivers (Black/African American, White/Caucasian, rural, urban) compared dementia caregivers participating in Telephone Support Groups to caregivers whose family members with dementia were receiving usual care. Either the caregiver or the patient had to be a veteran receiving care at the VAMC Memphis. In the treatment condition, there were 15 year-long support groups of one trained group leader and 5 to 6 caregivers. Each support group met 14 times. The one hour calls were semi-structured conference calls with education, coping skills and cognitive restructuring, and support components. A Caregiver Notebook with information on each topic provided materials for the educational sessions. Topics included knowledge of dementia, safety, caregiver health and well being, communication, managing behavioral challenges, and caregiver stress and coping. A workshop focusing on the same behavior management and stress topics was offered to Usual Care caregivers at the end of their participation.

Data were collected in caregivers' homes by trained Research Associates at baseline, six and twelve months. VHA health care use and data for the veteran were based on the Patient Treatment File (PTF) and the Outpatient Clinic File (OPC) and costs data used the Health Economics Resource Center (HERC) Average Cost Data Sets.

02

Conditions studied

  • Dementia
  • Alzheimer Disease

Keywords

  • Caregiver
  • Dementia
  • Alzheimer Disease
  • Telephone
  • Randomized Controlled Trials
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 154 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
154 participants (actual)

Study arms

  • Experimental
    Arm 1

    Telephone support groups

    Behavioral: Telephone Support

  • No intervention
    Arm 2

    Usual VA care

Interventions

  • BehavioralTelephone Support

    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.

06

What researchers measure

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.

    Time frame: 6 and 12 months

Secondary outcomes

  1. Cost-Effectiveness

    Time frame: 6 and 12 months

  2. Time spent providing care

    Time frame: 6 and 12 months

07

Study locations

1 site
  • Memphis VA Medical Center, Memphis, TN
    Memphis, Tennessee 38104, United States
08

References and documents

Publications

  • 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. PubMed 22917945 ↗
  • 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. PubMed 24617278 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00119561
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Jul 13, 2005
Start date
Feb 2005
Primary completion
Jun 2007
Completion
Jan 2014
Last update
Apr 7, 2015

Study contacts

Linda Olivia Nichols, PhD
principal investigator · Memphis VA Medical Center, Memphis, TN

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion