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A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia

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: NCT02672800
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Shelley Peacock, University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 3, 2016
Last Update Posted Date May 4, 2018
Study Start Date  ICMJE March 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
  • Inventory of Daily Widowed Life (IDWL)- change at 1 and 2 months post-intervention [ Time Frame: The measure will be administered pre-intervention, 1 month following the introduction of the intervention, and 2 months following the introduction of the intervention ]
    Measure of finding balance in bereavement
  • Center for Epidemiologic Studies Depression Scale- Revised (CESD-R)- change at 1 and 2 months post-intervention [ Time Frame: The measure will be administered pre-intervention, 1 month following the introduction of the intervention, and 2 months following the introduction of the intervention ]
    Measure of depressive symptoms
  • Texas Revised Inventory of Grief, Present Feelings- change at 1 and 2 months post-intervention [ Time Frame: The measure will be administered pre-intervention, 1 month following the introduction of the intervention, and 2 months following the introduction of the intervention ]
    Measure of grief
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
Semi-structured qualitative evaluation interviews [ Time Frame: Post intervention (after 1 month) ]
Measure of the feasibility and acceptability of the intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia
Official Title  ICMJE A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia: Adapting the "Finding Balance" Tool
Brief Summary The purpose of this study is to evaluate the feasibility and acceptability of a writing intervention (Reclaiming Yourself), intended to facilitate bereavement for spousal caregivers whose partners died with dementia.
Detailed Description

The current research is part 3 of a multi-phase project, whose purpose was to examine the experience of bereavement for spousal caregivers to persons with dementia. Based on spouses' shared experiences and the input of experts in the field (i.e. bereavement/dementia researchers, health care providers), an existing writing intervention called the Finding Balance tool was adapted from the context of cancer bereavement to that of dementia.

The purpose of this third phase is to test this adapted writing intervention (Reclaiming Yourself) with bereaved spouses of persons with dementia. Participants will be randomly assigned into one of two groups: treatment (who will receive the tool); and control (who will not be offered the tool until a later stage). The feasibility and acceptability of the intervention will be assessed, as well as the degree to which it facilitated participants' bereavement, ability to find balance, and psychological health.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Dementia
  • Bereavement
Intervention  ICMJE Behavioral: the Reclaiming Yourself tool
This tool is a behavioural writing intervention, intended to facilitate bereavement for spousal caregivers of persons with dementia
Study Arms  ICMJE
  • Experimental: Writing intervention
    Intervention: Behavioral: the Reclaiming Yourself tool
  • No Intervention: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2018)
16
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2016)
60
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • bereaved for three months or longer
  • were a caregiver for their spouse with advanced dementia
  • English speaking
  • willing and able to share their bereavement experience

Exclusion Criteria:

  • those with other than a spousal relationship to the person with dementia
  • spousal caregivers of persons with another terminal disease
  • those bereaved less than 3 months
  • those unable to provide consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02672800
Other Study ID Numbers  ICMJE 15-313
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Shelley Peacock, University of Saskatchewan
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Saskatchewan
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shelley Peacock, RN, PhD University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date May 2018

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