Stroke Self-Management: Effect on Function and Stroke Specific Quality of Life

NCT01507688 | Completed Results DMC

• 1 other identifier: SDP 10-379
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 2

Brief Summary

The experience of a stroke event may result in a disruption to the survivor's daily life. Patients with stroke have reported fears of permanent disability and major concerns over their ability to recover and be productive and engaged with family, friends and coworkers. To enhance recovery from stroke, the investigators designed a stroke self-management program and have pilot tested the program among Veterans recovering from stroke/TIA. The study is a three-site, randomized controlled trial designed to test the efficacy of a stroke self-management program. The intervention program includes 6 bi-weekly sessions over months 1-3 followed by monthly telephone calls as the investigators administered in the investigators' pilot study during months 4-6 for a total length of program duration of 6 months. The investigators have added 3 monthly group support sessions during months 4-6 for additional peer support. Thus, participants will receive bi-monthly support during months 4-6. The three intervention sites include the Jesse Brown VAMC in Chicago, the Roudebush VAMC in Indianapolis, and the IU Health Methodist Hospital in Indianapolis, Indiana. The three hospitals represent facilities with a small, moderate, and large volume of acute stroke care, respectively. Additionally, Methodist Hospital includes a greater proportion of women which enables us to study the patterns and preferences of women with stroke/TIA and tailor the investigators' future programs to prepare for the increasing female Veteran population.

Conditions

Stroke

Keywords

Stroke; Self-Management; Transient ischemic attack; Self-Efficacy

Outcome Measures

Primary Outcomes (1)

• Total Stroke Specific Quality of Life

  A 49-item instrument that assesses 12 domains relevant to stroke patients' health-related quality of life including: energy, mobility, work, upper extremity function, activities of daily living, family roles, social roles, vision, language, thinking, mood, and personality. A lower score indicates poorer functioning and a higher score indicates better functioning. The minimum value was 1 and maximum value was 5. A Total Stroke Specific Quality of Life Score was calculated as the mean of the 49-items.

  Change from baseline to 6 months

Study Arms (2)

Arm 1 SSM Intervention

EXPERIMENTAL

Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.

Behavioral: Stroke Self-Management

Arm 2 Usual Care

NO INTERVENTION

Usual care

Interventions

Stroke Self-Management BEHAVIORAL

Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.

Arm 1 SSM Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient eligibility criteria include:
• age 18 or older;
• acute diagnosis of ischemic stroke or TIA within past 12 months;
• able to speak and understand English;
• no severe cognitive impairment;
• access to a telephone;
• willing to follow-up in VA/IU Health outpatient care;
• had a previous outpatient primary care visit during the past 12 months in VA/IU Health outpatient care;
• willing to attend all individual phone and group meetings during the 6 month intervention; and
• life expectancy of at least 6 months as defined by the patient's neurologist at stroke event.

You may not qualify if:

• Short Portable Mental Status score \< 7;
• Significant language comprehension (NIH Stroke Scale commands score \> 0); or
• Receptive language deficits (NIH Stroke Scale aphasia score \> 2).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (5)

• Chen CX, Kroenke K, Stump TE, Kean J, Carpenter JS, Krebs EE, Bair MJ, Damush TM, Monahan PO. Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials. Pain. 2018 Apr;159(4):775-782. doi: 10.1097/j.pain.0000000000001121.

  PMID: 29200181 BACKGROUND

• Chen CX, Kroenke K, Stump T, Kean J, Krebs EE, Bair MJ, Damush T, Monahan PO. Comparative Responsiveness of the PROMIS Pain Interference Short Forms With Legacy Pain Measures: Results From Three Randomized Clinical Trials. J Pain. 2019 Jun;20(6):664-675. doi: 10.1016/j.jpain.2018.11.010. Epub 2018 Dec 6.

  PMID: 30529442 RESULT

• Kroenke K, Stump TE, Chen CX, Kean J, Bair MJ, Damush TM, Krebs EE, Monahan PO. Minimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials. J Affect Disord. 2020 Apr 1;266:100-108. doi: 10.1016/j.jad.2020.01.101. Epub 2020 Jan 23.

  PMID: 32056864 RESULT

• Kroenke K, Stump TE, Chen CX, Kean J, Damush TM, Bair MJ, Krebs EE, Monahan PO. Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials. Health Qual Life Outcomes. 2021 Feb 4;19(1):41. doi: 10.1186/s12955-021-01674-3.

  PMID: 33541362 RESULT

• Kroenke K, Stump TE, Kean J, Krebs EE, Damush TM, Bair MJ, Monahan PO. Diagnostic operating characteristics of PROMIS scales in screening for depression. J Psychosom Res. 2021 Aug;147:110532. doi: 10.1016/j.jpsychores.2021.110532. Epub 2021 May 25.

  PMID: 34052655 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Limitations and Caveats

Participants who agreed to participate may have had a greater interest in managing their health compared to the general population.

Results Point of Contact

• Title: Teresa Damush Ph.D.
• Organization: VA HSRD PRIS-M QUERI and CHIC HSRD Centers

Teresa.Damush@va.gov

317-988-4277

Study Officials

• Teresa M. Damush, PhD

  Richard L. Roudebush VA Medical Center, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 11, 2012
• Study Start: January 7, 2013
• Primary Completion: March 31, 2017
• Study Completion: August 29, 2019
• Last Updated: July 27, 2023
• Results First Posted: April 1, 2019

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Limited de-identified dataset will be shared after publication completion beginning 2022 for 5 years.

Locations

US (2)