Evaluation of the Stroke Caregiver Education and Support Program (FICSS)
|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.|
|ClinicalTrials.gov Identifier: NCT01355029|
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : March 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: Stroke Caregiver Education and Support Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
- 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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355029
|Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Gail Mores, B.Sc. Rec.||March of Dimes, Canada|