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A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia

Primary Purpose

Dementia, Bereavement

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
the Reclaiming Yourself tool
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Writing intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

Inventory of Daily Widowed Life (IDWL)- change at 1 and 2 months post-intervention
Measure of finding balance in bereavement
Center for Epidemiologic Studies Depression Scale- Revised (CESD-R)- change at 1 and 2 months post-intervention
Measure of depressive symptoms
Texas Revised Inventory of Grief, Present Feelings- change at 1 and 2 months post-intervention
Measure of grief

Secondary Outcome Measures

Semi-structured qualitative evaluation interviews
Measure of the feasibility and acceptability of the intervention

Full Information

First Posted
January 28, 2016
Last Updated
May 1, 2018
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT02672800
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Bereavement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Writing intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
the Reclaiming Yourself tool
Intervention Description
This tool is a behavioural writing intervention, intended to facilitate bereavement for spousal caregivers of persons with dementia
Primary Outcome Measure Information:
Title
Inventory of Daily Widowed Life (IDWL)- change at 1 and 2 months post-intervention
Description
Measure of finding balance in bereavement
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
Title
Center for Epidemiologic Studies Depression Scale- Revised (CESD-R)- change at 1 and 2 months post-intervention
Description
Measure of depressive symptoms
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
Title
Texas Revised Inventory of Grief, Present Feelings- change at 1 and 2 months post-intervention
Description
Measure of grief
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
Secondary Outcome Measure Information:
Title
Semi-structured qualitative evaluation interviews
Description
Measure of the feasibility and acceptability of the intervention
Time Frame
Post intervention (after 1 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelley Peacock, RN, PhD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7J3Z1
Country
Canada

12. IPD Sharing Statement

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A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia

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