Online Caregiver Psychoeducation and Support for Alzheimer's

Alzheimer's Disease Clinical Trial

Official title:

Caregiver Psychoeducation and Support: Improving Outcomes in AD/ADRD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416078
• Other study ID #: IIR 05-107
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 22, 2006
• Last updated: April 7, 2015
• Start date: August 2007
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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..

Description:

Alzheimer's disease (AD) is a progressive brain disease resulting in cognitive and functional decline. While some pharmacological agents and behavioral programs are now available to slow the rate of decline, there is no cure. Caregivers, who typically are the female spouses or daughters of afflicted individuals, must confront both the deterioration of a loved one, and that person's need for increasingly demanding care. Caregivers tend to experience high levels of depression, anxiety, and burden. Data suggest that providing education, social support, and ongoing professional consultation to families involved in the care of a relative with AD results in improvement in caregiver psychological status, and sometimes even slows the functional decline of the patient.

Recent technological advancements in video conferencing, online communication, and streaming audio/video presentations, which are increasingly easy to use and gaining widespread acceptance among mental health professionals as well as the public, have given rise to a great deal of interest in telemedicine and telepsychiatry. This study tested an Internet-based family intervention for AD that relatives can access from their homes with ease, and at no cost. In addition to improving patient outcomes through instruction of effective behavioral management, we proposed that participation in an Internet program would also reduce caregiver depression and burden. Fifty-three veterans with a clinical diagnosis of AD and their caregiver/relatives were 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 6 months. We hypothesized that, at the end of the active intervention, participation in the intensive intervention would result reduced patient problematic behavior, caregiver burden, depression, and negative responses to problematic patient behaviors, as well as improved patient medication compliance. At 12 month follow-up, we hypothesized access to the online program would result in more patients remaining at home. The overriding longterm project objective was to develop an effective online education and support program for caregivers of patients with AD that can be manualized, replicated, and disseminated to other clinical and research centers, within both the VA health care system and the community, to enhance the efficiency and effectiveness of psychosocial treatment in AD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• caregiver website support
caregiver access to website support for 6 months embedded in one year of customary care
• caregiver brief supportive phone calls
caregiver brief supportive telephone calls for 6 months embedded in one year of customary care

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West LA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Placed in Assisted Living or Nursing Homes 12 Months From Baseline	Frequency count of individuals placed in assisted living or nursing homes	baseline to end-of-follow-up (12 months from baseline)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	Change in Caregiver Report of Patient Medication Adherence From Baseline	Adherence to prescribed medication regimen rated by caregiver on a 1 (0%) to 5 (100%) scale. Higher scores indicate better adherence. Values in statistical table below are least square estimates, and thus may be slightly out-of-range of actual respondent choices on scale.	baseline to end-of-treatment (6 months)	No