ClinicalTrials.gov

History of Changes for Study: NCT02672800
A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia
Latest version (submitted May 1, 2018) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 February 1, 2016 None (earliest Version on record)
2 November 4, 2016 Recruitment Status, Study Status and Contacts/Locations
3 June 12, 2017 Study Status
4 May 1, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT02672800
Submitted Date:  February 1, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 15-313
Brief Title: A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia
Official Title: A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia: Adapting the "Finding Balance" Tool
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2016
Overall Status: Not yet recruiting
Study Start: March 2016
Primary Completion: May 2016 [Anticipated]
Study Completion: July 2016 [Anticipated]
First Submitted: January 28, 2016
First Submitted that
Met QC Criteria:
February 1, 2016
First Posted: February 3, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 1, 2016
Last Update Posted: February 3, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Saskatchewan
Responsible Party: Principal Investigator
Investigator: Shelley Peacock
Official Title: Assistant Professor, College of Nursing
Affiliation: University of Saskatchewan
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Dementia
Bereavement
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 60 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Writing intervention Behavioral: the Reclaiming Yourself tool
This tool is a behavioural writing intervention, intended to facilitate bereavement for spousal caregivers of persons with dementia
No Intervention: Control
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
2. 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
3. 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
Secondary Outcome Measures:
1. Semi-structured qualitative evaluation interviews
[ Time Frame: Post intervention (after 1 month) ]

Measure of the feasibility and acceptability of the intervention
Open or close this module Eligibility
Minimum Age: 60 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Shelley Peacock, RN, PhD
Telephone: (306) 966-7375
Email: shelley.peacock@usask.ca
Study Officials: Shelley Peacock, RN, PhD
Principal Investigator
University of Saskatchewan
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services