N/A N=53 Randomized Double-blind Treatment

Internet and Telephone Support Intervention for Stroke Caregivers

Depression · Quality of Life · Recovery of Function · Self Efficacy · Stress

Bottom Line

View on ClinicalTrials.gov: NCT04348851 ↗

Enrolled (actual)

Serious AEs

1.9%

Results posted

May 2020

Primary outcome: Primary: Change in Depressive Symptoms — -2.31; 1.00; .08; 3.9 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Caregiver problem-solving (Behavioral); Attention Control (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Depressive Symptoms	.92; -1.50; -3.46; 1.92	—
PRIMARY Change in Caregiver Burden	-.08; -.40; -.38; -.54	—
PRIMARY Change in Depressive Symptoms	.92; -1.50; -3.46; 1.92	—
PRIMARY Change in Caregiver Burden	-.08; -.40; -.38; -.54	—
SECONDARY Change in Health-Related Quality of Life - Physical Scale	-.48; 1.11; -7.50; .16	—
SECONDARY Change in Perceived Stress	.92; .10; .54; 1.15	—
SECONDARY Change in Stroke Knowledge	-.08; -.20; -.08; .15	—
SECONDARY Changes in Problem-Solving Abilities	4.31; 4.55; 3.92; -1.07	—
SECONDARY Caregiving Self-efficacy	-.23; .18; .77; -.71	—
SECONDARY Change in Veteran Functional Abilities	-3.85; 4.00; 2.31; 0.00	—
SECONDARY Change in Health-Related Quality of Life - Physical Scale	-.48; 1.11; -7.50; .16	—
SECONDARY Change in Perceived Stress	.92; .10; .54; 1.15	—
SECONDARY Change in Stroke Knowledge	-.08; -.20; -.08; .15	—
SECONDARY Change in Problem-Solving Abilities	3.15; 7.40; -1.77; -1.08	—
SECONDARY Change in Caregiving Self-Efficacy	-.23; .20; .38; -.62	—
SECONDARY Change in Veteran Functional Abilities	-3.85; 4.00; 2.31; 0.00	—
SECONDARY Change in Health-Related Quality of Life - Mental Scale	1.44; -1.47; -4.32; -.99	—
SECONDARY Change in Health-Related Quality of Life - Mental Scale	1.44; -1.47; -4.32; -.99	—

Summary

This study will test a problem-solving and support intervention for caregivers of veterans with stroke. The investigators will assign caregivers to one for four groups: 4-session intervention, 8-session intervention, attention control (active listening), or standard care. The investigators will assess the impact of the intervention on caregiver outcomes (depression, burden, stress, problem-solving abilities, self-efficacy, and quality of life) and veteran outcomes (functional abilities).

Eligibility Criteria

Inclusion Criteria

All non-paid caregivers of Veterans with a primary diagnosis of stroke, discharged to home from a medical or rehabilitation facility are eligible for participation if they meet the following criteria:

have caregiving responsibility for a Veteran who has a diagnosis of stroke (ICD9 codes for stroke: 430-438) within the last 2.5 years and who have at least one activity of daily living (ADL), cognitive, or speech deficit related to stroke
score 1 or greater on the Perceived Stress Scale
have Internet access and ability
are reachable by their cell or home phones
read English at a seventh-grade reading level or better
agree to random assignment to a study arm

Exclusion Criteria

The investigators will exclude caregivers who fail to meet one or more of the inclusion criteria and whose Veterans:

have a life expectancy of less than 6 months
are receiving hospice/palliative care or are residing in a community living center
Life expectancy will be determined by reviewing the electronic health record (EHR) and conferring with our physician and clinical team members

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04348851). 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.