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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01883375
Other study ID # H2013:024
Secondary ID
Status Completed
Phase N/A
First received February 11, 2013
Last updated December 12, 2017
Start date March 2013
Est. completion date October 31, 2017

Study information

Verified date November 2016
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dying patients and their families face many challenges near the end-of-life. Not only do patients often experience physical distress, but they also have feelings of loss of dignity, isolation, and uncertainty. Family members also face many challenges. They bear witness to the suffering of loved ones, and they face uncertainty, loss, and at times a mounting sense of helplessness.

The purpose of this study is to introduce and evaluate a new intervention called Dignity Talk, meant to enhance end-of-life experience for both patients and their families. Dignity Talk is based on a set of questions by which terminally ill patients and their family members can engage in meaningful conversations with each other. It is intended to lessen feelings of loss and helplessness and enhance feelings of connectedness by facilitating conversations that tap into a sense of meaning and purpose, sharing of memories, wishes, hopes, and giving guidance to those who will soon be left behind.

In Phase 1, 20 patients and family members will help finalize the method and Dignity Talk question framework (is it easy to understand, do the investigators have the right questions, and is the wording sensitive). In Phase 2 of the study the investigators will ask 100 patient-family pairs for feedback about Dignity Talk: what influence it had on their palliative care experience, whether it works well, and whether this intervention should become a regular part of palliative care. The investigators will also ask for feedback from health-care providers in both phases. We are requesting approval for an amendment to the healthcare provider feedback focus group questions. Will add those documents when they are approved.

Four to six months after the death of their loved one, the investigators will contact the family member to ask their thoughts about Dignity Talk, how it shaped their experience of their grief and bereavement.

The investigators expect that the study will show that Dignity Talk can be an effective, highly accessible palliative care intervention, which will enhance the end-of-life experience for palliative patients and the families who support them.


Description:

See above summary


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date October 31, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

For Patient:

Patients being cared for:

- in a palliative care unit or whose care is focused on palliation as determined by clinical staff

- or patients who have have a confirmed diagnosis of amyotropic lateral sclerosis, and have symptoms in a domain that interferes with their social or occupation functioning: a) mobility, b) dysphasia, c) dyspnea, or d) speech or patients who have are have been on dialysis > 3 months and are > 60 years of age - or residents of Personal Care Home all of whom are:

- 18 years of age or older

- able to provide informed oral and written consent

- cognitive capacity (based on clinical consensus)

For Family Member or Close Friend:

- Family member or close friend who the patient identifies they would be comfortable talking with using the Dignity Talk question framework

- Family member who is 18 years of age or older

- Family member who is able to provide oral and written consent

- Family member who has cognitive capacity to participate in meaningful conversation (based on research staff decision)

For Healthcare Provider:

- Employed one of the participating sites

- in a discipline directly involved in clinical care (physician, nursing, social work, spiritual care, allied healthcare, etc.)

Exclusion Criteria:

- not meeting the above inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Dignity Talk
Patient and family member participants will be given the Dignity Talk framework questions and asked to use them in conversation with each other. Research nurse will return at day 4-6 to confirm both participants have covered all items they wish to discuss. 4-6 months after the death of patient, family members will be contacted in order to collect data pertaining to their bereavement experiences and distress. Will also be asked to complete evaluative feedback on Dignity Talk.
The Dignity Talk Communication Topics
There have not been any non-completers - this arm not being used currently

Locations

Country Name City State
Canada Dr. Bob Kemp Hospice Hamilton Ontario
Canada Victoria Hospice Victoria British Columbia
Canada Concordia Hospital Winnipeg Manitoba
Canada Deer Lodge Centre Winnipeg Manitoba
Canada Grace Hospital Winnipeg Manitoba
Canada Health Sciences Centre Winnipeg Manitoba
Canada Manitoba Renal Program Winnipeg Manitoba
Canada Riverview Health Centre Winnipeg Manitoba
Canada Seven Oaks Hospital Winnipeg Manitoba
Canada St. Boniface Hospital Winnipeg Manitoba
Canada Victoria Hospital Winnipeg Manitoba
Canada Winnipeg Regional Health Authority Winnipeg Manitoba
Canada WRHA Personal Care Homes Winnipeg Manitoba

Sponsors (2)

Lead Sponsor Collaborator
University of Manitoba Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Family communication connectedness Index 31 months
Secondary Number of Participants with Adverse Events as a Measure of Safety and Tolerability 31 months
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