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The Impact of an Early Palliative Care Telehealth Intervention on Caregiver Burden and Quality of Life in Caregivers of Stroke Patients

Protocol summary

Study aim
Determining the effect of early palliative care telehealth intervention on the caregiver burden and quality of life in caregivers of stroke patients
Design
A randomized, parallel-group, controlled clinical trial with 35 caregivers in each group. Randomization process will be performed using the Block Randomization method.
Settings and conduct
Imam Hossein, Shohadaye Tajrish, and Logman-e Hakim hospitals in Tehran city
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Having a first-degree relative with the patient (father, mother, spouse, sister, brother, child) 2) Having responsibility for full-time care and follow-up of the patient's treatment (having the largest share of care) 3) Being literate 4) Having a smart phone Exclusion criteria: 1) Having a confirmed diagnosis of psychological disorders by a psychiatrist 2) People whose patient died during the study 3) People who do not attend two (or more) of the total number of training and follow-up sessions 4) People who have participated in training sessions related to other similar research 5) Incomplete completion of questionnaires
Intervention groups
The intervention group will receive early palliative care training across five virtual 30–40 minute sessions. The sessions cover: 1) palliative care principles for stroke patients; 2) problem-solving and the COPE (creativity, optimism, problem-solving, and specialized information) framework; 3) self-care practices including nutrition, exercise, smoking cessation, relaxation, and help-seeking; 4) management of physical and emotional symptoms, self-assessment, and symptom reporting to guide physician prioritization of palliative care and spiritual concerns; and 5) values elicitation, advance care planning, and decision-making support. The control group will receive standard nurse-delivered hospital training.
Main outcome variables
Caregiver burden; Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240609062065N6
Registration date: 2026-08-11, 1405/05/20
Registration timing: prospective

Last update: 2026-08-11, 1405/05/20
Update count: 0
Registration date
2026-08-11, 1405/05/20
Registrant information
Name
Amir mohamad Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 095 7427
Email address
nazari.amir7009@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-23, 1405/06/01
Expected recruitment end date
2026-11-22, 1405/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of an Early Palliative Care Telehealth Intervention on Caregiver Burden and Quality of Life in Caregivers of Stroke Patients
Public title
The Impact of an Early Palliative Care Telehealth Intervention in Caregivers of Stroke Patients
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Having a first-degree relative with the patient (father, mother, spouse, sister, brother, child) Having responsibility for full-time care and follow-up of the patient's treatment (having the largest share of care) Being literate Having a smart phone
Exclusion criteria:
Having a confirmed diagnosis of psychological disorders by a psychiatrist People whose patient died during the study People who do not attend two (or more) of the total number of training and follow-up sessions People who have participated in training sessions related to other similar research Incomplete completion of questionnaires
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be selected via convenience sampling and randomly assigned to intervention or control groups using block randomization with a block size of four. The block lists were numbered from 1 to 6, and each patient received a unique identification code. Allocation concealment will be maintained through sealed, opaque, sequentially numbered envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Arabi Ave, Daneshjoo Blvd
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2026-06-07, 1405/03/17
Ethics committee reference number
IR.SBMU.RETECH.REC.1405.166

Health conditions studied

1

Description of health condition studied
Stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome

Primary outcomes

1

Description
Caregiver burden
Timepoint
Before the intervention, immediately after the intervention, and 8 weeks later
Method of measurement
Zarit caregiver burden scale

2

Description
Quality of life
Timepoint
Before the intervention, immediately after the intervention, and 8 weeks later
Method of measurement
SF-36 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group will receive early palliative care training across five virtual 30–40 minute sessions. The sessions cover: 1) palliative care principles for stroke patients; 2) problem-solving and the COPE (creativity, optimism, problem-solving, and specialized information) framework; 3) self-care practices including nutrition, exercise, smoking cessation, relaxation, and help-seeking; 4) management of physical and emotional symptoms, self-assessment, and symptom reporting to guide physician prioritization of palliative care and spiritual concerns; and 5) values elicitation, advance care planning, and decision-making support.
Category
Other

2

Description
Control group: This group will receive standard nurse-delivered hospital training.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Amir Mohamad Nazari
Street address
Shahid Madani St
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
ehmc.sbmu.ac@gmail.com

2

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Amir Mohamad Nazari
Street address
Shahrdari St
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Pr_shohada@sbmu.ac.ir

3

Recruitment center
Name of recruitment center
Loghman-e Hakim Hospital
Full name of responsible person
Amir Mohamad Nazari
Street address
Kamali St
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Arabi Ave, Daneshjoo Blvd
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mohamad Nazari
Position
Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 916 095 7427
Email
nazari.amir7009@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mohamad Nazari
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 916 095 7427
Email
nazari.amir7009@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mohamad Nazari
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 916 095 7427
Email
nazari.amir7009@gmail.com

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
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