Trial Outcomes & Findings for Implementing Evidence in the Detection and Treatment of Post Stroke Depression (NCT NCT00296140)

NCT ID: NCT00296140

Last Updated: 2018-08-28

Results Overview

Patient Health Questionnaire-9, measures depression symptoms, range 0-27, higher values represent more depression symptoms

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-08-28

Participant Flow

Participant milestones

Measure	Self Management of PSD Symptoms Self management of PSD symptoms (plus PSD screening and treatment). Intervention subjects received a manualized self-management program consisting of a series of 24 of stroke self-management topics delivered in six bi-weekly telephone calls. Each session also incorporated goal setting and behavioral contracting for the specific goal identified by the subject. All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention.	Screening and Treatment of PSD Screening and treatment of PSD (plus attention-control calls). All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention. Attention-control subjects received six bi-weekly telephone calls asking about their general health post-stroke; no specific educational, self-management, or other topics were delivered.
Overall Study STARTED	33	33
Overall Study COMPLETED	30	33
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Self Management of PSD Symptoms Self management of PSD symptoms (plus PSD screening and treatment). Intervention subjects received a manualized self-management program consisting of a series of 24 of stroke self-management topics delivered in six bi-weekly telephone calls. Each session also incorporated goal setting and behavioral contracting for the specific goal identified by the subject. All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention.	Screening and Treatment of PSD Screening and treatment of PSD (plus attention-control calls). All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention. Attention-control subjects received six bi-weekly telephone calls asking about their general health post-stroke; no specific educational, self-management, or other topics were delivered.
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	0
Overall Study Discharge to Nursing Home	1	0

Baseline Characteristics

Implementing Evidence in the Detection and Treatment of Post Stroke Depression

Baseline characteristics by cohort

Measure	Self Management of PSD Symptoms n=30 Participants Self management of PSD symptoms (plus PSD screening and treatment). Intervention subjects received a manualized self-management program consisting of a series of 24 of stroke self-management topics delivered in six bi-weekly telephone calls. Each session also incorporated goal setting and behavioral contracting for the specific goal identified by the subject. All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention.	Screening and Treatment of PSD n=33 Participants Screening and treatment of PSD (plus attention-control calls). All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention. Attention-control subjects received six bi-weekly telephone calls asking about their general health post-stroke; no specific educational, self-management, or other topics were delivered.	Total n=63 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 12.4 • n=5 Participants	64.0 years STANDARD_DEVIATION 8.4 • n=7 Participants	65.6 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Race/Ethnicity, Customized Black	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized White	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	33 participants n=7 Participants	63 participants n=5 Participants
Living status Alone	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Living status With one other	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Living status With 2 or more others	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Caregiver Present Yes	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Caregiver Present No	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
National Institute of Health Stroke Scale score	3.0 points n=5 Participants	2.0 points n=7 Participants	2.0 points n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Comparison of PHQ-9 scores between intervention and control groups

Patient Health Questionnaire-9, measures depression symptoms, range 0-27, higher values represent more depression symptoms

Outcome measures

Measure	Self Management of PSD Symptoms n=30 Participants Self management of PSD symptoms (plus PSD screening and treatment). Intervention subjects received a manualized self-management program consisting of a series of 24 of stroke self-management topics delivered in six bi-weekly telephone calls. Each session also incorporated goal setting and behavioral contracting for the specific goal identified by the subject. All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention.	Screening and Treatment of PSD n=33 Participants Screening and treatment of PSD (plus attention-control calls). All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention. Attention-control subjects received six bi-weekly telephone calls asking about their general health post-stroke; no specific educational, self-management, or other topics were delivered.
PHQ-9	6.4 units on a scale Standard Deviation 6.0	4.4 units on a scale Standard Deviation 5.1

SECONDARY outcome

Timeframe: 6 months

Population: Comparison of overall SS-QOL scores between intervention and control subjects

Stroke-specific quality of life scale, score range 1.0 - 5.0, higher scores indicate better self-reported quality of life.

Outcome measures

Measure	Self Management of PSD Symptoms n=30 Participants Self management of PSD symptoms (plus PSD screening and treatment). Intervention subjects received a manualized self-management program consisting of a series of 24 of stroke self-management topics delivered in six bi-weekly telephone calls. Each session also incorporated goal setting and behavioral contracting for the specific goal identified by the subject. All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention.	Screening and Treatment of PSD n=33 Participants Screening and treatment of PSD (plus attention-control calls). All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention. Attention-control subjects received six bi-weekly telephone calls asking about their general health post-stroke; no specific educational, self-management, or other topics were delivered.
SS-QOL	4.0 units on a scale Standard Deviation 0.9	4.1 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 6 months

Population: Comparison of self-rated self efficacy for managing stroke symptoms between intervention and control subjects

Patient-reported self-efficacy for stroke symptom management, range 1.0 - 10.0, higher scores indicate greater self-efficacy for stroke symptom management

Outcome measures

Measure	Self Management of PSD Symptoms n=29 Participants Self management of PSD symptoms (plus PSD screening and treatment). Intervention subjects received a manualized self-management program consisting of a series of 24 of stroke self-management topics delivered in six bi-weekly telephone calls. Each session also incorporated goal setting and behavioral contracting for the specific goal identified by the subject. All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention.	Screening and Treatment of PSD n=32 Participants Screening and treatment of PSD (plus attention-control calls). All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention. Attention-control subjects received six bi-weekly telephone calls asking about their general health post-stroke; no specific educational, self-management, or other topics were delivered.
Self-efficacy	8.8 units on a scale Standard Deviation 3.1	8.5 units on a scale Standard Deviation 3.7

Adverse Events

Self Management of PSD Symptoms

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Screening and Treatment of PSD

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Self Management of PSD Symptoms n=33 participants at risk Self management of PSD symptoms (plus PSD screening and treatment). Intervention subjects received a manualized self-management program consisting of a series of 24 of stroke self-management topics delivered in six bi-weekly telephone calls. Each session also incorporated goal setting and behavioral contracting for the specific goal identified by the subject. All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention.	Screening and Treatment of PSD n=33 participants at risk Screening and treatment of PSD (plus attention-control calls). All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention. Attention-control subjects received six bi-weekly telephone calls asking about their general health post-stroke; no specific educational, self-management, or other topics were delivered.
General disorders Emergency department visit	3.0% 1/33 • Number of events 1	0.00% 0/33
Nervous system disorders Emergency department visit	3.0% 1/33 • Number of events 1	0.00% 0/33

Other adverse events

Measure	Self Management of PSD Symptoms n=33 participants at risk Self management of PSD symptoms (plus PSD screening and treatment). Intervention subjects received a manualized self-management program consisting of a series of 24 of stroke self-management topics delivered in six bi-weekly telephone calls. Each session also incorporated goal setting and behavioral contracting for the specific goal identified by the subject. All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention.	Screening and Treatment of PSD n=33 participants at risk Screening and treatment of PSD (plus attention-control calls). All subjects received care at a site where an ongoing clinical reminder to screen and treat patients for PSD was being implemented as part of a quality improvement intervention. Attention-control subjects received six bi-weekly telephone calls asking about their general health post-stroke; no specific educational, self-management, or other topics were delivered.
Musculoskeletal and connective tissue disorders ER visit	3.0% 1/33 • Number of events 1	12.1% 4/33 • Number of events 4
General disorders Hospitalization for unrelated, anticipated cause	18.2% 6/33 • Number of events 6	21.2% 7/33 • Number of events 7

Additional Information

Dr. Linda Williams

Roudebush VA Medical Center

Phone: 317-988-2715

Email: Linda.Williams6@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place