Dignity Therapy for Patients With Early Dementia and Their Family
DTD
Dignity Therapy: a Brief Psychological and Existential Intervention for Patients With Early Dementia and Their Family. A Randomized Controlled Trial
1 other identifier
interventional
54
1 country
1
Brief Summary
Developed by Harvey M. Chochinov in 2005, Dignity Therapy (DT) invites individuals with life-limiting illnesses to reflect on matters of importance to them and compiles them in a narrative document for the patient to share. DT has shown to improve quality of life and a sense of dignity, as well as supporting relatives in the process of grievance. Featuring a gradual loss of memories of the past, decline of cognitive functions and awareness of self, dementia can be regarded as a life-limiting or life-changing illness, which is often accompanied by significant psychological stress. DT may help patients and their relatives reduce this stress. Yet, no studies have been conducted to determine the benefits of DT in patients with early stage dementia (ESD). This study investigates the feasibility and acceptance of DT by patients with (very) mild dementia (CDR: 0.5 - 1.5) and their relatives, as well as their overall satisfaction. This study further seeks to determine the effects of DT on sense of dignity, quality of life, dyadic coping, and levels of anxiety and depression in a randomized controlled design.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedFirst Posted
Study publicly available on registry
October 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedJune 15, 2021
June 1, 2021
2.6 years
September 27, 2018
June 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Participation and refusal rate of Dignity Therapy among Patients with an early stage dementia
Acceptance based on the participation and refusal rate and dropout rate.
10 days post randomization
Overall satisfaction of patients and their relatives
Overall satisfaction is indicated by answers to the Dignity Therapy Evaluation Questionnaire (DTEQ), which includes 10 items.
10 days post randomization
Secondary Outcomes (1)
Psychological distress
10 days post randomization
Study Arms (2)
Interventiongroup
EXPERIMENTALDignity Therapy. Patients receive dignity-therapy-Intervention after randomization
Waitinggroup
NO INTERVENTIONPatients receive dignity-therapy-Intervention after a waiting time of 3 months post randomization
Interventions
Dignity Therapy (DT) invites individuals with life-limiting illnesses to reflect on matters of importance to them and compiles them in a narrative document for the patient to share.
Eligibility Criteria
You may qualify if:
- Signed Informed Consent
- Diagnosis of very mild dementia
- older 18 years of age
- Study partner (life partner, relative, close friend) available
You may not qualify if:
- Unable to speak and read German
- Physical or cognitive incapacity to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Zurichlead
- Waid City Hospital, Zurichcollaborator
Study Sites (1)
University of Zurixh
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2018
First Posted
October 2, 2018
Study Start
October 1, 2018
Primary Completion
April 30, 2021
Study Completion
May 31, 2021
Last Updated
June 15, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share