Phase 3 N=53 Randomized Single-blind Treatment

Online Caregiver Psychoeducation and Support for Alzheimer's

Alzheimer's Disease

Bottom Line

View on ClinicalTrials.gov: NCT00416078 ↗

Enrolled (actual)

Serious AEs

17.0%

Results posted

Apr 2015

Primary outcome: Primary: Change in Caregiver Burden From Baseline — 32.04; 28.59; 32.52; 27.55 units on a scale — p=.51

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: caregiver website support (Behavioral); caregiver brief supportive phone calls (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Caregiver Burden From Baseline	32.04; 28.59; 32.52; 27.55	.51
PRIMARY Change in Frequency of Patient Problematic Behavioral Patterns From Baseline	30.69; 33.04; 33.28; 34.75	.79
PRIMARY Change in Caregiver Negative Reactions to Problematic Behavioral Patterns From Baseline	16.04; 19.09; 20.23; 20.08	.49
PRIMARY Change in Caregiver Depression From Baseline	9.27; 9.20; 8.61; 9.43	.67
SECONDARY Change in Caregiver Report of Patient Medication Adherence From Baseline	4.63; 4.06; 5.08; 3.94	.65

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..

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00416078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.