Palliative CareNCT02483390
Use of Online Communications to Support Patients and Their Families in the Hospice Unit
A study testing psychosocial intervention in people with Palliative Care, run by Pesach Shvartzman.
Trial summary
The increasing awareness of the importance of palliative care has led, in Israel, to the 2005 Law for the Rights of Persons with Terminal Illness. Still, problems of accessibility to palliative care remain unresolved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care
- What is being tested?
- psychosocial intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient currently receiving care from the home hospice unit,
- over the age of 18,
- able to give informed consent,
- with a computer that can use SKYPE or a smartphone,
- speaking a language of the psychosocial staff person (Hebrew, English, Russian, Arabic).
Who cannot join
- Brain tumors,
- dementia,
- speech disturbance,
- refusal to participate,
- language other than the four spoken by psychosocial staff members,
- inability to use technology or lack of computer in the home.
Trial locations and contacts
No sites are listed yet.
About this study
The increasing awareness of the importance of palliative care has led, in Israel, to the 2005 Law for the Rights of Persons with Terminal Illness. Still, problems of accessibility to palliative care remain unresolved. The use of e-health services is likely to expand the ability of the medical, psychosocial and nursing staff to reach patients who are either living in the periphery, are unable to make clinic visits or whose family members are housebound in order to be caregivers. This exploratory research is designed to explore the issues, barriers and advantages of e-health care through the perspective of the palliative care staff members, the patients themselves and their caregiving family members.
Read the detailed description
This study is designed to test the applicability and suitability of e-health services (e.g. by use of SKYPE) to the psychosocial needs of patients and their families who are getting services through home hospice care. In addition, the attitudes of the hospice staff will be investigated to the use of e-health methods. The study will clarify selection criteria, referral pathways and barriers and/or supporting elements that will allow e-health services to be provided in a highly professional fashion. Up to 20 dyads of a patient and their primary caregiver will be recruited from those who are receiving services from the home hospice unit of the Kupat Holim Clalit (General Sick Fund) in the South of Israel.
- Conditions
- Palliative Care
- Being tested
- psychosocial intervention
- Keywords
- palliative care, e-health, e-therapy, psychosocial services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocial interventionOther
e-health services (e.g. by use of SKYPE) to the psychosocial needs of patients and their families who are getting services through home hospice care. In addition, the attitudes of the hospice staff will be investigated to the use of e-health methods.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: All dyads are in the intervention arm. | Experimental | Not described Receives: Other: psychosocial intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
SWAT - The social work assessment tool
Tool to assess the quality of social work psychosocial services
Measured: One year
Secondary outcomes (5)
EIS (Emotional Intimacy Scale)
assess the emotional intimacy component a close relationship
Measured: 6 month
SLDS (Satisfaction with cancer scale)
assess cancer patient quality of life
Measured: 6 month
the will to live question
assess the will to live in a specific time point
Measured: 6 month
ZBI (Zarit burden scale),
assess primary care burden
Measured: 6 month
attitudes toward use of e-therapy questionnaire.
estimate attitudes of professional care giver
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pesach Shvartzman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pesach Shvartzman, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483390
- Sponsor's protocol ID
- ק007/2015
- Status last verified
- Jun 2015
- First submitted
- 10 Jun 2015
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Online Communications to Support Patients and Their Families in the Hospice Unit
- ClinicalTrials.gov ID
- NCT02483390
- Acronym / sponsor ID
- ק007/2015
- Conditions
- Palliative Care
- Keywords
- palliative care, e-health, e-therapy, psychosocial services
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pesach ShvartzmanUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The increasing awareness of the importance of palliative care has led, in Israel, to the 2005 Law for the Rights of Persons with Terminal Illness. Still, problems of accessibility to palliative care remain unresolved. The use of e-health services is likely to expand the ability of the medical, psychosocial and nursing staff to reach patients who are either living in the periphery, are unable to make clinic visits or whose family members are housebound in order to be caregivers. This exploratory research is designed to explore the issues, barriers and advantages of e-health care through the perspective of the palliative care staff members, the patients themselves and their caregiving family members.
Detailed description
This study is designed to test the applicability and suitability of e-health services (e.g. by use of SKYPE) to the psychosocial needs of patients and their families who are getting services through home hospice care. In addition, the attitudes of the hospice staff will be investigated to the use of e-health methods. The study will clarify selection criteria, referral pathways and barriers and/or supporting elements that will allow e-health services to be provided in a highly professional fashion. Up to 20 dyads of a patient and their primary caregiver will be recruited from those who are receiving services from the home hospice unit of the Kupat Holim Clalit (General Sick Fund) in the South of Israel.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group: All dyads are in the intervention arm. | Experimental | Other: psychosocial intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient currently receiving care from the home hospice unit,
- over the age of 18,
- able to give informed consent,
- with a computer that can use SKYPE or a smartphone,
- speaking a language of the psychosocial staff person (Hebrew, English, Russian, Arabic).
Key exclusion criteria (6 listed)
- Brain tumors,
- dementia,
- speech disturbance,
- refusal to participate,
- language other than the four spoken by psychosocial staff members,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| psychosocial interventione-health services (e.g. by use of SKYPE) to the psychosocial needs of patients and their families who are getting services through home hospice care. In addition, the attitudes of the hospice staff will be investigated to the use of e-health methods. | Other | Intervention group: All dyads are in the intervention arm. |
Primary outcome
SWAT - The social work assessment tool
Time frame: One year
Tool to assess the quality of social work psychosocial services
5 secondary outcomes
EIS (Emotional Intimacy Scale)
Time frame: 6 month
SLDS (Satisfaction with cancer scale)
Time frame: 6 month
the will to live question
Time frame: 6 month
ZBI (Zarit burden scale),
Time frame: 6 month
attitudes toward use of e-therapy questionnaire.
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
Related trials for Palliative Care
Not yet recruitingObservational study
IN-TALK: Co-producing a Hospice Intimacy Support Toolkit in England
Communication About Intimacy Needs in Hospice and Palliative Care
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Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1/2
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
Malignant Solid Neoplasm
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
Not yet recruiting
Comparing Radiotherapy Dose Strategies for Symptom Relief in Large Solid Tumors
Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing psychosocial intervention in people with Palliative Care, run by Pesach Shvartzman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pesach Shvartzman, M.D. (972-8-6477429, SPESAH@BGU.AC.IL), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SWAT - The social work assessment tool (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2015.