Online Caregiver Psychoeducation and Support for Alzheimer's

NCT00416078 | Completed Phase 2 Results

• 1 other identifier: IIR 05-107
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This study is piloting an internet-based intervention to provide support for caregivers of VA patients with Alzheimer's disease or related memory difficulties (ADRD). Veterans with a clinical diagnosis of ADRD and their caregiver/relatives will be randomized to receive one of two interventions: (1) customary care (cc) and access to an intensive, interactive online education and support website intervention for 6 months, or (2) cc and monthly brief telephone calls with project staff for six month. It is hypothesized that participation in the intensive intervention will result in a reductions in patient problematic behavior and caregiver responses to it, reduced caregiver burden and depression, and improved medication adherence at the end of treatment, and more patients remaining at home through the 12 months post-randomization period..

Conditions

Alzheimer's Disease

Keywords

technology development and assessment; internet; randomized control trial

Outcome Measures

Primary Outcomes (4)

• Change in Caregiver Burden From Baseline

  Total score on the Zarit Short Burden Scale, a 12 item instrument that utilizes a likert scale 1-5 rating of frequency. The range is 12 (never) to 60 (nearly always) wherein higher scores are more indicative of caregiver burden.

  baseline to end-of-treatment (6 months)

• Change in Frequency of Patient Problematic Behavioral Patterns From Baseline

  Total Score on the Frequency of Problematic Behaviors on the Revised Memory and Behavior Problem Checklist. The Revised Memory and Behavior Checklist is a 24 item instrument that measures the frequency of a behavior on a 0-4 likert scale wherein higher numbers indicate greater frequency. The range is 0-96.

  baseline to end of treatment (6 months)

• Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline

  Total Score on the Negative Reactions Scale from the Revised Memory and Behavior Problem Checklist. The scale measures the caregiver's level of reaction to a series of potential problematic behaviors on a 0-4 likert scale; higher numbers indicate a greater degree of distress. The range is 0-96.

  baseline to end of treatment (6 months)

• Change in Caregiver Depression From Baseline

  Total score on the Beck Depression Inventory. The Beck Depression Inventory is a 21 item likert scale instrument with a total range of 0 to 63. Higher scores are indicative of increased endorsement of depressive symptoms. Additionally, it utilizes a cutoff score of13 to indicate probable depression

  baseline to end-of-treatment (6 months)

Secondary Outcomes (1)

• Change in Caregiver Report of Patient Medication Adherence From Baseline

  baseline to end-of-treatment (6 months)

Other Outcomes (1)

• Number of Participants Placed in Assisted Living or Nursing Homes 12 Months From Baseline

  baseline to end-of-follow-up (12 months from baseline)

Study Arms (2)

caregiver website support

EXPERIMENTAL

caregiver access to website support for 6 months embedded in one year of customary care

Behavioral: caregiver website support

caregiver brief supportive phone calls

ACTIVE COMPARATOR

caregiver brief supportive telephone calls for 6 months embedded in one year of customary care

Behavioral: caregiver brief supportive phone calls

Interventions

caregiver website support BEHAVIORAL

caregiver access to website support for 6 months embedded in one year of customary care

caregiver website support

caregiver brief supportive phone calls BEHAVIORAL

caregiver brief supportive telephone calls for 6 months embedded in one year of customary care

caregiver brief supportive phone calls

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient living in community and ambulatory
• Patient has diagnosis of Alzheimer's disease
• Patient age 50-95
• Caregiver age 18-90
• Patient currently under treatment for Alzheimer's disease
• Patient and caregiver reside within 2 hours of Los Angeles
• Caregiver has home internet access
• Patient has close contact with caregiver

You may not qualify if:

• Patient lives in residential setting
• No family contact
• Acute illness or chronic disease in patient or caregiver
• Patient or caregiver plans to leave area within the year

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

Related Publications (2)

• Hayden LJ, Glynn SM, Hahn TJ, Randall F, Randolph E. The use of Internet technology for psychoeducation and support with dementia caregivers. Psychol Serv. 2012 May;9(2):215-8. doi: 10.1037/a0027056.

  PMID: 22662739 RESULT

• Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.

  PMID: 33417236 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Theodore Hahn
• Organization: VAGLAHS at West Los Angeles

thahn@ucla.edu

3102684108

Study Officials

• Theodore J. Hahn, MD

  VA Greater Los Angeles Healthcare System, West LA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2006
• First Posted: December 27, 2006
• Study Start: August 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 29, 2015
• Results First Posted: April 29, 2015

Record last verified: 2015-04

Locations

US (1)