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Evaluation of the Stroke Caregiver Education and Support Program (FICSS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01355029
First Posted: May 17, 2011
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Gail Mores, March of Dimes, Canada
May 13, 2011
May 17, 2011
March 16, 2016
February 2011
December 2012   (Final data collection date for primary outcome measure)
Change in Baseline Bakas Caregiving Outcome Scale at 2 Weeks and 6 Months post Intervention [ Time Frame: Baseline, 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.
Same as current
Complete list of historical versions of study NCT01355029 on ClinicalTrials.gov Archive Site
  • Change in Baseline Oberst Caregiving Burden Scale at 2 Weeks and 6 Months Post Intervention [ Time Frame: Baseline, 2 weeks and 6 months post intervention ]
    15 item self report instrument using a 5 point Likert scale to evaluate caregiver perceptions of the time and difficulty associated with 15 tasks performed in caring for recovering family members. It has been validated in cancer and stroke caregiver populations. It has demonstrated internal consistency reliability of 0.90 - 0.94 and validity of between 0.61 to 0.82 in stroke caregivers.
  • Open Ended Focus Group Interview to assess impact of program weeks and 6 months post intervention [ Time Frame: 2 weeks and 6 months post Intervention ]
    The questions will be designed to assess the impact on the stroke caregiver; perceived improvement in problem solving abilities; increased awareness and usage of community services; any indirect influence on the stroke survivor; timing of the intervention; and evaluation of the FICSS project.
  • Caregiver Baseline/Stroke Survivor Baseline Questionnaire [ Time Frame: Baseline ]
    Caregiver Baseline/Stroke Survivor Baseline Questionnaire is a 26 item questionnaire that collects socio-demographic and health related information of the stroke survivor and caregiver. The questionnaire is an adaptation of the one developed by Dr. Jill Cameron to include socio-demographic and health related information on the stroke survivor. The original questionnaire has been utilized in her initial and ongoing research in her "Timing it Right Framework" for stroke caregivers. Permission has been granted by Dr. Cameron to utilize the questionnaire for the study.
Same as current
Not Provided
Not Provided
 
Evaluation of the Stroke Caregiver Education and Support Program
A Pilot Study of the Evaluation of the Family Informal Caregiver Stroke Self Management (FICSS) Research Project: Impact on Caregiver Psychosocial, Emotional and Health Needs
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.
The modules in the program are: 1) Program Introduction, sharing Caregiving Stories and an introduction to Self Management; 2) 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? The programs provides education, information and strategies to deal with the areas that caregivers struggle with as caregivers in order to help them feel better able to prepared to manage as caregivers. Also, the investigators also hope to develop some beginning understanding of when is the best time to provide the program to stroke caregivers to be most helpful to them in their caregiving role.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Stroke
Behavioral: Stroke Caregiver Education and Support Program
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?
Other Name: FICSS Program
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
December 2012
December 2012   (Final data collection date for primary outcome measure)

Informal unpaid family stroke caregivers

Inclusion Criteria:

Informal unpaid family stroke caregivers

  • 18 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.

Exclusion Criteria:

Caregivers who:

  • Paid to provide care;
  • Are friends who provide care to stroke survivor;
  • Are providing palliative care to stroke survivor within the home.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01355029
OSN1101-000119
10-668 ( Other Identifier: Hamilton Health Sciences McMaster University REB )
No
Not Provided
Not Provided
Gail Mores, March of Dimes, Canada
March of Dimes, Canada
Hamilton Health Sciences Corporation
Principal Investigator: Gail Mores, B.Sc. Rec. March of Dimes, Canada
March of Dimes, Canada
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP