NCT01355029

Brief Summary

The study will be evaluating to a 4 week education and support program for stroke caregivers. The 4 week program will provide education, information, and strategies for dealing with areas that caregivers may find challenging in their caregiving role. The study will evaluate the effectiveness of the program to decrease the caregiver's stress, strain and burden, increase the caregiver's knowledge of strategies and community services and increase their role satisfaction as a stroke caregiver and quality of life two weeks after the program and 6 months after the program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

May 13, 2011

Last Update Submit

March 14, 2016

Conditions

Keywords

Stroke caregiversFamily CaregiversStroke

Outcome Measures

Primary Outcomes (1)

  • Change in Baseline Bakas Caregiving Outcome Scale at 2 Weeks and 6 Months post Intervention

    12 item self report instrument using a 7 point Likert scale 4 designed to measure changes in post stroke caregiver family life changes in the areas of social functioning, subjective well being and physical health,financial well-being, physical functioning, general health, roles in life and level of energy. The revised scale has demonstrated internal consistency reliability of 0.90 and construct validity of 0.66 5. The scale measures both the positive and negative aspects of caregiving with an emphasis on social consequences.

    Baseline, 2 weeks and 6 months Post Intervention

Secondary Outcomes (3)

  • Change in Baseline Oberst Caregiving Burden Scale at 2 Weeks and 6 Months Post Intervention

    Baseline, 2 weeks and 6 months post intervention

  • Open Ended Focus Group Interview to assess impact of program weeks and 6 months post intervention

    2 weeks and 6 months post Intervention

  • Caregiver Baseline/Stroke Survivor Baseline Questionnaire

    Baseline

Interventions

4 week program offered weekly over a 4 week period. Each session is a 2 hour small group guided discussion on the topic area facilitated by 2 trained facilitators. The topics are: Program Introduction, sharing Caregiving Stories and an introduction to Self Management; Community Connections; Session 3 and 4 are chosen by the participants during session 1 from 6 possible options: Communication in your relationship; Cognition, Memory and Personhood; Dealing with your Emotions; Managing your Stress; Changing roles in your relationships and How to be Caregiver Smart?

Also known as: FICSS Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informal unpaid family stroke caregivers
  • years of age or older;
  • Have provided care to stroke survivor within the home for at least 2 months;
  • Have the ability to communicate in English;
  • Live within Central South Ontario Stroke Region or the West GTA Stroke Region.

You may not qualify if:

  • Caregivers who:
  • Paid to provide care;
  • Are friends who provide care to stroke survivor;
  • Are providing palliative care to stroke survivor within the home.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gail Mores, B.Sc. Rec.

    March of Dimes, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, National and Provincial Programs

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 17, 2011

Study Start

February 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations