NCT04348851

Internet and Telephone Support Intervention for Stroke Caregivers

Completed NA Results posted Last updated 2 June 2020

What this trial tests

NA trial testing Caregiver problem-solving in Depression in 53 participants. Completed in 1 October 2016.

Timeline

1 October 2014

Primary endpoint
19 September 2016

1 October 2016

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	53
Start date	1 October 2014
Primary completion	19 September 2016
Estimated completion	1 October 2016
Sites	1 location across United States

Drugs / interventions tested

• Caregiver problem-solving
• Attention Control

Conditions studied

• Depression — all drugs for Depression →
• Quality of Life — all drugs for Quality of Life →
• Recovery of Function — all drugs for Recovery of Function →
• Self Efficacy — all drugs for Self Efficacy →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Depression or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Depressive Symptoms Primary · 9 weeks after baseline

Changes in depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale. The CES-D is a 20-item, 4-point Likert scale ranging from never (0) to most of the time (3). Possible scores range from 0-60 with higher scores indicating more symptoms. It has been used in numerous studies with caregivers and has good reliability and validity.

Group	Value	95% CI
4-Week Intervention	-2.31	± 4.80
8-Week Intervention	1.00	± 7.52
8-Week Attention Control	.08	± 11.03
Standard Care	3.9	± 8.66

Change in Caregiver Burden Primary · 9 weeks after baseline

Changes in burden will be measured by the Short Version of the Zarit Burden Interview (S-ZBI). This 12-item instrument was reduced from the original 29-item instrument. This instrument is scored on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). Possible scores range from 0-48 with higher scores indicating higher burden. The instrument was originally developed to measure dementia caregiver burden, but, the S-ZBI has been used in stroke caregiver studies and items are appropriate for other caregiver populations.

Group	Value	95% CI
4-Week Intervention	-.92	± 4.33
8-Week Intervention	.18	± 3.34
8-Week Attention Control	-.62	± 7.03
Standard Care	.14	± 5.10

Change in Depressive Symptoms Primary · 25 weeks after baseline

Change in depressive symptoms will be measured with the Center for Epidemiologic Studies Depression (CES-D) scale. The CES-D is a 20-item, 4-point Likert scale ranging from never (0) to most of the time (3). Possible scores range from 0-60 with higher scores indicating more symptoms. It has been used in numerous studies with caregivers and has good reliability and validity.

Group	Value	95% CI
4-Week Intervention	.92	± 8.88
8-Week Intervention	-1.50	± 4.58
8-Week Attention Control	-3.46	± 9.65
Standard Care	1.92	± 4.87

Change in Caregiver Burden Primary · 25 weeks after baseline

Changes in burden will be measured by the Short Version of the Zarit Burden Interview. This 12-item instrument was reduced from the original 29-item instrument. This instrument is scored on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). Possible scores range from 0-48 with higher scores indicating higher burden. The instrument was originally developed to measure dementia caregiver burden, but, the S-ZBI has been used in stroke caregiver studies and items are appropriate for other caregiver populations.

Group	Value	95% CI
4-Week Intervention	-.08	± 5.36
8-Week Intervention	-.40	± 5.52
8-Week Attention Control	-.38	± 5.39
Standard Care	-.54	± 3.5

Change in Health-Related Quality of Life - Physical Scale Secondary · 9 weeks after baseline

Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR-12 items are scored on a 3-point or 5-point Likert scale ranging from. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life.

Group	Value	95% CI
4-Week Intervention	.70	± 5.66
8-Week Intervention	1.91	± 6.77
8-Week Attention Control	-3.18	± 10.12
Standard Care	.50	± 7.23

Change in Perceived Stress Secondary · 9 weeks after baseline

Changes in perceived stress will be measured by the Perceived Stress Scale (PSS-4). The 4-item measure asses stress experienced in the last month on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores range from 0-16, with higher scores indicating more stress.

Group	Value	95% CI
4-Week Intervention	1.23	± 2.49
8-Week Intervention	.27	± 2.41
8-Week Attention Control	.15	± 2.54
Standard Care	1.86	± 2.44

Change in Stroke Knowledge Secondary · 9 weeks after baseline

Change in stroke knowledge will be measured by the Stroke Knowledge Instrument developed by the National Institutes of Health. This 7-item tool consists of true/false and multiple choice responses. Scores range from 0-7, with higher scores indicating more stroke knowledge.

Group	Value	95% CI
4-Week Intervention	-.15	± 1.34
8-Week Intervention	.27	± 1.01
8-Week Attention Control	.15	± 1.34
Standard Care	.29	± .99

Changes in Problem-Solving Abilities Secondary · 9 weeks after baseline

Changes in problem-solving abilities will be measured by the Social Problem-Solving Inventory - Short Form (SPSI-SF). The SPSI-SF is a 25-item tool consisting of five subscales (problem-solving orientation, rational problem-solving, negative problem-solving, impulsivity, avoidance style problem solving). Raw scores must first be converted to standard scores, which range from 0-20 for each of the 5 subscales. Higher scores on the problem-solving orientation and rational problem-solving scales indicate better problem-solving abilities, while higher scores on the negative problem-solving, impulsi

Group	Value	95% CI
4-Week Intervention	4.31	± 12.28
8-Week Intervention	4.55	± 8.24
8-Week Attention Control	3.92	± 6.98
Standard Care	-1.07	± 9.45

Caregiving Self-efficacy Secondary · 9 weeks after baseline

Changes in caregiving self-efficacy will be measured by the Caregiver Self-Efficacy Scale. This 14-item tool measures caregivers' judgments regarding their ability to perform effectively. Responses are binary (0=no, 1=yes) and scores range from 0-14, with higher scores indicating greater self-efficacy.

Group	Value	95% CI
4-Week Intervention	-.23	± 1.54
8-Week Intervention	.18	± 3.54
8-Week Attention Control	.77	± 2.17
Standard Care	-.71	± 1.07

Change in Veteran Functional Abilities Secondary · 9 weeks after baseline

Change in Veteran functional abilities will be measured by the Barthel Index, which measures patients' abilities to perform 10 self-care tasks. Response options vary for each item and are scored on 5-point increments (e.g., 0=unable, 5=needs help, 10-independent). Total scores range from 0-100 with higher scores indicating greater functional abilities.

Group	Value	95% CI
4-Week Intervention	-1.92	± 14.51
8-Week Intervention	2.27	± 9.32
8-Week Attention Control	4.62	± 9.23
Standard Care	1.43	± 11.17

Change in Health-Related Quality of Life - Physical Scale Secondary · 25 weeks after baseline

Changes in health-related quality of life will be measured by the Rand 12-item Health Survey (VR-12). The VR12 items are scored on a 3-point or 5-point Likert scale ranging from. It consists of physical and emotional scales. Scores for each scale are calculated by using an algorithm and scores are standardized using a T-score metric with a mean of 50 and standard deviation of 10. Higher scores indicate better health-related quality of life.

Group	Value	95% CI
4-Week Intervention	-.48	± 8.14
8-Week Intervention	1.11	± 8.96
8-Week Attention Control	-7.50	± 13.19
Standard Care	.16	± 5.87

Change in Perceived Stress Secondary · 25 weeks after baseline

Changes in stress will be measured by the Perceived Stress Scale (PSS-4). The 4-item measure asses stress experienced in the last month on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Scores range from 0-16, with higher scores indicating more stress.

Group	Value	95% CI
4-Week Intervention	.92	± 2.60
8-Week Intervention	.10	± 2.42
8-Week Attention Control	.54	± 2.99
Standard Care	1.15	± 2.12

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

4-Week Intervention

Serious: 1/13 (8%)

Deaths: 0/13

8-Week Intervention

Serious: 0/13 (0%)

Deaths: 0/13

8-Week Attention Control

Serious: 0/13 (0%)

Deaths: 0/13

Standard Care

Serious: 0/14 (0%)

Deaths: 0/14

Serious adverse events (1 terms)

Reaction	System	4-Week Intervention	8-Week Intervention	8-Week Attention Control	Standard Care
Seizures	Nervous system disorders	—	—	—	—

Most-reported serious reactions: Seizures.

Data from ClinicalTrials.gov NCT04348851 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.