Protocol summary
-
Study aim
-
Determining the effect of in-person and virtual Dignity Therapy on the quality of life and life satisfaction of patients with heart failure
-
Design
-
A controlled clinical trial, non-randomized, conducted on 90 patients.
-
Settings and conduct
-
The present study is a clinical trial with two intervention groups and one control group, using a convenience sampling method. The target population consists of 90 patients with class II, III, or IV heart failure who are referred to Imam Khomeini Hospital Complex, affiliated with Tehran University of Medical Sciences. The Dignity Therapy protocol will be implemented in three sessions for the intervention groups. A four-part questionnaire including demographic information, the Chronic Heart Failure Quality of Life Questionnaire (CHFQOLQ-20), the Satisfaction With Life Scale (SWLS), and the Generalized Anxiety Disorder 7-item scale (GAD-7) will be completed by participants in all three groups at two time points: before the intervention and one month after the intervention.
-
Participants/Inclusion and exclusion criteria
-
Inclusion Criteria:
Diagnosis of heart failure by a specialist physician
Mental health stability and absence of psychological disorders according to the medical record
Ability to use a smartphone and access to the internet
Exclusion Criteria:
Deterioration of the patient's health condition
Participation in educational or therapeutic sessions similar to the intervention
-
Intervention groups
-
The control group receives monitoring and the routine treatments and care provided by the center. In addition to this, the in-person intervention group receives Dignity Therapy through face-to-face sessions, and the virtual intervention group receives Dignity Therapy via video calls.
-
Main outcome variables
-
Quality of life; Life satisfaction
General information
-
Reason for update
-
Misspelling
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20250714066482N1
Registration date:
2025-07-15, 1404/04/24
Registration timing:
prospective
Last update:
2025-07-19, 1404/04/28
Update count:
1
-
Registration date
-
2025-07-15, 1404/04/24
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2025-08-05, 1404/05/14
-
Expected recruitment end date
-
2025-11-05, 1404/08/14
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Investigating the Effect of In-Person and Virtual Dignity Therapy on Quality of Life and Life Satisfaction in Patients with Heart Failure
-
Public title
-
The Effect of Dignity Therapy on Quality of Life and Life Satisfaction in Patients with Heart Failure
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Diagnosis of class II, III, or IV heart failure based on the New York Heart Association (NYHA) classification by a specialist physician
Willingness and informed consent to participate in the study
Absence of severe illness-related conditions that would prevent participation in the intervention
Mental health stability and no significant psychological issues such as severe anxiety, depression, suicidal thoughts, obsessive-compulsive disorder, or other psychological disorders, according to the patient’s medical records
Ability to use a smartphone and access the internet
Adequate hearing and speaking abilities to participate in interviews
Minimum literacy in reading and writing in Persian
No cognitive impairments
Age over 18 years
Exclusion criteria:
Lack of willingness to continue participation in the study
Deterioration of the patient's health condition
Participation in educational or therapeutic sessions similar to the intervention
Death
Re-hospitalization
-
Age
-
From 18 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
90
-
Randomization (investigator's opinion)
-
Not randomized
-
Randomization description
-
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2025-07-09, 1404/04/18
-
Ethics committee reference number
-
IR.TUMS.FNM.REC.1404.085
Health conditions studied
1
-
Description of health condition studied
-
Patients with heart failure
-
ICD-10 code
-
I50
-
ICD-10 code description
-
Heart failure
Primary outcomes
1
-
Description
-
ْQuality of life
-
Timepoint
-
Before intervention and one month after the end of intervention
-
Method of measurement
-
Chronic heart failure health-related quality of life questionnaire (CHFQOLQ-20)
2
-
Description
-
life satisfaction
-
Timepoint
-
Before intervention and one month after the end of intervention
-
Method of measurement
-
Satisfaction With Life Scale (SWLS)
Secondary outcomes
1
-
Description
-
Anxiety
-
Timepoint
-
Before the intervention and one month after the end of the intervention
-
Method of measurement
-
Generalized Anxiety Disorder (GAD-7)
Intervention groups
1
-
Description
-
Intervention group: In the in-person group, the intervention is carried out through a structured process consisting of three face-to-face sessions, each lasting 30 to 60 minutes, with intervals of 24 to 48 hours.In the first session, participants are introduced to the study and the Dignity Therapy interview framework. They are given the opportunity to reflect on the questions before the formal interview begins.In the second session, the researcher conducts an interview with the patient, asking specific questions to explore their life history, values, beliefs, and concerns in order to identify what matters most to them. With the participant’s consent, the interview is recorded using a voice recorder.After the second session, based on the information gathered, the researcher prepares a written narrative that includes the patient’s important memories, accomplishments, values, and messages for their family and loved ones.In the third session, the written narrative is reviewed together with the patient to ensure it accurately reflects their views and emotions. Any necessary revisions are made. Finally, the completed version is presented to the patient as a booklet and, if desired, to their family.
-
Category
-
Other
2
-
Description
-
Intervention group: In the virtual group, the intervention is conducted through a structured process consisting of three individual sessions held via video calls, each lasting 30 to 60 minutes, with intervals of 24 to 48 hours.In the first session, participants are introduced to the study and the Dignity Therapy interview framework. They are given time to reflect on the questions before the formal interview begins.In the second session, the researcher conducts a virtual interview with the patient, asking specific questions to explore their life history, values, beliefs, and concerns in order to identify what matters most to them. With the participant’s consent, the interview is recorded using a voice recorder.After the second session, based on the collected information, the researcher prepares a written narrative that includes the patient’s meaningful memories, achievements, values, and messages for their family and loved ones.In the third session, the written narrative is reviewed with the patient to ensure that it accurately reflects their thoughts and feelings. Any necessary revisions are made. Finally, the finalized version is presented to the patient as a booklet and, if desired, to their family.
-
Category
-
Other
3
-
Description
-
Control group: Participants in the control group will undergo monitoring and receive the routine treatments and care provided by the center.
-
Category
-
Other
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Tehran University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available