Stress in people recovering from stroke

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12617000736347
• Date of registration: 19/05/2017
• Prospective Registration: Yes
• Primary sponsor: Hunter Stroke Service
• Public title: Stress in people recovering from stroke
• Scientific title: Development and implementation of improved monitoring of psychological stress loads in people recovering from stroke.
• Date of first enrolment: 09/10/2017
• Target sample size: 140
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12617000736347.aspx
• Study type: Observational
• Study design: Purpose: Screening;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: A/Prof Frederick Rohan Walker

• Name: A/Prof Frederick Rohan Walker

Key inclusion & exclusion criteria

Inclusion criteria: Participants with stroke who:
have had a stroke in the last 12 months or longer
no previous history of pituitary and adrenal gland diseases

Age-match controls are participants:
without medical history of stroke
do not have any previous medical history of adrenal and pituitary gland diseases
Exclusion criteria: Participants are discharged to a high dependency medical care environment, have a language other than English as their first language, have a previous history of pituitary or adrenal disease (Cushing or Addison’s).

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Stroke - Haemorrhagic

Stroke - Ischaemic

Stroke;
Stroke

Intervention(s)

The purpose of the study is to find out if stress impacts a person’s ability to recover from a stroke. The study will monitor stress levels in people who have had stroke in the last 12 months or longer to determine how their recovery is progressing, and whether they are experiencing significant stress levels.

Participants with stroke in the last 12 months will be recruited through social media advertisements, radio, stroke community groups and the Hunter Stroke Research Volunteer Register. Healthy age matched controls will be recruited from the Hunter Medical Research Institute volunteer register.

Participants will require to visit Hunter Medical Research Institute for one-off appointment with the researchers. Participants will provide a blood sample and hair sample for the analysis of stress hormones. Participants will also complete a list of surveys including clinical and anthropometrics details; Perceived stress (Perceived Stress Scale), Cognition (CANTAB, particularly subscales directed towards sustained attention and executive function); Fatigue (Fatigue Assessment Scale); Resiliency (using the CD-RISC and the BRS) and Recovery (Stroke Impact Scale for participants with stroke only),

Primary Outcome(s)

Stress as assessed by Perceived Stress Scale (PSS), hair cortisol level and blood cortisol levels (composite outcome)
[Assessed at single baseline timepoint only]

Secondary Outcome(s)

Changes in cognition scores as assessed by CANTAB battery of tests, particularly in those people who suffer severe strokes
[Assessed at single baseline timepoint only]

Changes in fatigue scores as assessed by Fatigue Assessment Scale , particularly in those people who suffer severe strokes [Assessed at single baseline timepoint only]

Changes in stroke impact scores as assessed by Stroke Impact Scale[Assessed at single baseline timepoint only]

Changes in resilience scores as assessed by Connor-Davidson Resilience Scale and Brief Resilience Scale, particularly in those people who suffer severe strokes
[Assessed at single baseline timepoint only]

Secondary ID(s)

None

Source(s) of Monetary Support

Hunter Medical Research Institute

John Hunter Hospital Charitable Trust Fund

Ethics review

Status: Approved
Approval date:
Contact:

Hunter New England Human Research Ethics Committee

Results

• Results available: Yes
• Date Posted: 30/04/2019