Multiple SclerosisNCT03555253
Resilience-Based Program for Support Partners of Persons With Multiple Sclerosis
A study testing Resilience-Based Program for Support Partners of PwMS in people with Multiple Sclerosis, run by Healios Inc. at 1 site in United States.
Trial summary
This is a pilot feasibility study to examine the impact of providing a non-therapeutic resilience-based coaching telehealth program to the Support Partners (SP) of persons with MS (PwMS). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Resilience-Based Program for Support Partners of PwMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2018to 31 Mar 2019
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Support Partner Inclusion Criteria
In order to be eligible to participate in this study as a Support Partner, an individual must meet all of the following criteria:
- Provide signed and dated informed consent form.
- Willing to comply with all study procedures and be available for the duration of the study.
- Male or female, aged 21 to 65 years.
- Able to speak, read, and understand English.
- Reside in the U.S.
- Live with PwMS who is willing to participate in the study and who meets all of the eligibility criteria.
- Has access to a telephone and computer or tablet with a stable internet connection as well as a web camera in a private setting.
- Provide identification that meets the New Jersey Telemedicine Act of 2017.
- Demonstrate basic ability to use a computer by completing the electronic ICF completion process, which requires use of a teleconferencing platform similar to what will be used during the intervention.
Support Partner Exclusion Criteria
A Support Partner who meets any of the following criteria will be excluded from participation in this study:
- Professional healthcare worker (e.g., physician, psychologist, social worker, case manager, nurse, home healthcare aide).
- Dementia, including Alzheimer's and Lewy Bodies Dementia, as screened by CORE Therapy Assessment Form v.2.
- Reports that PwMS partner is diagnosed with dementia, including Alzheimer's and Lewy Bodies Dementia.
- Self-report of any change in medication treating bipolar disorder and any psychiatric condition, including a change in dosage, in the previous 6 months and as screened by CORE Therapy Assessment Form v.2.
- Current suicidal intent as screened by CORE-OM and CORE Therapy Assessment Form v.2.
- Currently participating in couple or family therapy.
- An intellectual or developmental disability as screened by CORE Therapy Assessment Form v.2.
- Evidence of significant brain injury or medical condition leading to cognitive impairment (e.g. accident, tumor) as screened by CORE Therapy Assessment Form v.2.
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
PwMS Inclusion Criteria
In order to be eligible to participate in this study as a Person with MS, an individual must meet all of the following criteria:
- Provide signed and dated informed consent form.
- Willing to comply with all study procedures and be available for the duration of the study.
- Male or female, aged 21 to 65 years.
- Self-report of Multiple Sclerosis including the date of the diagnosis (month and year) and the name of the diagnosing physician.
- Able to speak, read, and understand English.
- Reside in the U.S.
- Cognitive difficulty as screened by the PDQ Cognitive Function (score greater than 20).
- Live with Support Partner who meets all study eligibility criteria.
- Has access to a telephone and computer or tablet with a stable internet connection as well as a web camera in a private setting.
- Provide identification that meets the New Jersey Telemedicine Act of 2017.
- Demonstrate basic ability to use a computer by completing the electronic ICF completion process, which requires use of a teleconferencing platform similar to what will be used during the intervention.
PwMS Exclusion Criteria
A PwMS who meets any of the following criteria will be excluded from participation in this study:
- Dementia, including Alzheimer's and Lewy Bodies Dementia, as screened by CORE Therapy Assessment Form v.2.
- Self-report of any change in medication treating bipolar disorder and any psychiatric condition, including a change in dosage, in the previous 6 months and as screened by CORE Therapy Assessment Form v.2.
- Current suicidal intent as screened by CORE-OM and CORE Therapy Assessment Form v.2.
- Currently participating in couple or family therapy.
- Diagnosis of intellectual or developmental disability as screened by CORE Therapy Assessment Form v.2.
- Significant brain injury or medical condition leading to cognitive impairment (e.g. accident, tumor) as screened by CORE Therapy Assessment Form v.2.
- Self-report of any change in medication treating MS, including a change dosage, in the previous 3 months.
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Single-Center Study of a Manualized Resilience-Based Telehealth Program for Support Partners of Persons With Multiple Sclerosis
This is a pilot feasibility study to examine the impact of providing a non-therapeutic resilience-based coaching telehealth program to the Support Partners (SP) of persons with MS (PwMS).
Cognitive difficulties are a prominent feature in PwMS and prove to be a challenge for PwMS and the close family members that care for them. This study is a pilot telehealth program that aims to address these needs and improve the overall well-being of adults with MS and their Support Partners.
Read more
A manualized program was developed utilizing the previous research study conducted literature, and the expertise and experience of the research study team. Funding was sought and obtained for 30 pairs to participate in the pilot. The 6-session program will address needs identified by this population and improve knowledge of cognition in PwMS.
Study Objectives:
Primary Objective:
To conduct an evaluation of the feasibility of the resilience program by examining:
- Recruitment (i.e. willingness to participate in program)
- Participation rates and attrition
- Participant satisfaction of the program.
Secondary Objective (Support Partner):
To assess the potential long-term benefits of the program to Support Partners of PwMS. Program benefits will be assessed using the following outcomes:
- Sense of Competencies
- Understanding of cognitive impairment in MS
- Caregiver burden
- Positive Emotions.
Secondary Objective (PwMS):
To assess the potential long-term benefits of the program to PwMS. Program benefits will be assessed using the following outcomes:
- Relationship Satisfaction
- Perceived Support.
- Conditions
- Multiple Sclerosis
- Being tested
- Resilience-Based Program for Support Partners of PwMS
- Keywords
- Resilience, Telehealth, Well-being, Support, Caregiving
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience-Based Program for Support Partners of PwMSBehavioural
Support Partners will participate in six resilience coaching Program Sessions conducted weekly by a study resilience coach. PwMS will participate in the initial and final coaching Program Sessions with their Support Partners. The MyHealios Resilience Program for PwMS and their Support Partners has been designed to be interactive and include skills-based activities led by the Resilience coach. This includes skills of communication, problem solving, and learning about resilience and cognition in MS.
| Study group | Role | What they receive |
|---|---|---|
| PwMS and their Support Partner | Experimental | Support Partners will participate in six resilience coaching Program Sessions conducted weekly by a study resilience coach. PwMS will participate in the initial and final coaching Program Sessions with their Support Partners. Receives: Behavioral: Resilience-Based Program for Support Partners of PwMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment (i.e. willingness to participate in program)
Recruitment will end when 30 fully evaluable Support Partner - PwMS pairs have completed the study. It is expected that approximately 45 pairs will be enrolled in order to produce the 30 fully evaluable pairs.
Measured: Up to 1 year
Feasibility: Participation rates and attrition
Participation rates will be measured in terms of individual sessions completed. Attrition rates will be measured. Attrition or drop-out will be addressed as follows: those who drop out prior to the fourth session will be asked to complete a satisfaction questionnaire while those who drop out after the fourth session will be asked to complete post-measures and a satisfaction questionnaire.
Measured: Up to 1 year
Feasibility: Participant satisfaction of the program.
The Intervention Evaluation Questionnaire was created by the research lead as a self-report measure of the participant's evaluation of the intervention and the individual sessions. Participants' evaluation data will be presented as totals from one five-point Likert scale, three yes/no questions and four open questions. The scale question measures satisfaction with the program on a range from 0 (not at all satisfied) to 4 (very satisfied). In addition to this evaluation of the intervention, four questions will be asked at the end of each session to the participants of that session. This includes two five-point Likert scale questions and two open ended questions. The first scale question measures satisfaction with the session on a range from 1 (not at all satisfied) to 5 (very satisfied). The second scale question measures the perceived helpfulness of the session on a range from 1 (not at all satisfied) to 5 (very satisfied).
Measured: Up to 1 year
Secondary outcomes (11)
Change from Baseline: Sense of Competence Questionnaire (Support Partner)
The Sense of Competence Questionnaire will be used to measure the support partner's sense of competence in caring for a person with MS. The measure has twenty-seven items. Each item is a statement which the support partner is asked to endorse using a 5-point scale. Response options range from 1 (Yes, completely agrees) to 5 (no, completely disagrees). The three subscales are: satisfaction with care recipient (7 items), satisfaction with one's performance as a support partner (12 items), and consequences of involvement in care for the personal life of the support partner (8 items).
Measured: Up to 8 months from enrollment
Change from Baseline: Connor-Davidson Resilience Scale (Support Partner)
The 10-item version of the Connor-Davidson Resilience Scale will be used to measure the Support Partner's sense of their resilience when faced with stressful situations and negative emotions. The measure includes a total of ten items. Each item on the scale is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Not True at All) to 4 (True Nearly All the Time).
Measured: Up to 8 months from enrollment
Change from Baseline: Zarit Burden Interview (Support Partner)
The Zarit Burden Interview will be used to measure the Support Partner's feelings of burden related to caregiving. There are twenty-two items total. Each item is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always).
Measured: Up to 8 months from enrollment
Change from Baseline: Perceived Stress (Support Partner)
The Perceived Stress Survey (PSS) will be used to measure the support partner's perceptions about the nature of events and their relationship to the support partner's values and perceived coping resources. The PSS has 14 items total. Each item is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Very often).
Measured: Up to 8 months from enrollment
Change from Baseline: Knowledge Questionnaire (Support Partner)
The knowledge questionnaire was created by the research lead as a self-report measure of participant retention of the program's topics. The questionnaire has thirteen questions, nine which are multiple-choice questions whose response options are based on the session contents. There are also four scale questions. The first scale question measures the participant's self-reported resilience from 1 (not resilient at all) to 10 (very resilient). The second scale question measures the participant's comfort with their knowledge about cognition in multiple sclerosis from 1 (not comfortable at all) to 10 (very comfortable). The third scale question measures the participant's effectiveness at communicating with their partner from 1 (not effective at all) to 10 (very effective). The fourth scale question measures the participant's effectiveness when using problem-solving skills in dealing with day-to-day difficulties from 1 (not effective at all) to 10 (very effective).
Measured: Up to 8 months from enrollment
Change from Baseline: Positive and Negative Affect Schedule (Support Partner)
The Positive and Negative Affect Schedule will be used to measure the support partner's self-reported experience of positive and negative affect in the past week. The full PANAS has 20 items total. Each item describes an emotion, the recent experience of which (currently at the time of reporting or within the past week) the support partner is asked to endorse using a 5-point scale. Response options range from 1 (feeling the emotion slightly or not at all) or 5 (feeling the emotion often). Ten items describe positive emotion and ten items describe negative emotion.
Measured: Up to 8 months from enrollment
Change from Baseline: Burns Relationship Satisfaction Scale (Support Partner)
The Burns Relationship Satisfaction Scale (BRSS) will be used to assess the support partner's self-reported level of satisfaction in various areas of the relationship with the care recipient for spousal dyads. The BRSS has seven items. Each item describes a relationship area: communication and openness, conflict resolution, degree of caring and affection, intimacy and closeness, satisfaction with roles in relationship, and overall relationship satisfaction. The support partner is asked to rate their degree of satisfaction in each of these areas. Response options range from 0 (very dissatisfied) to 6 (very satisfied).
Measured: Up to 8 months from enrollment
Change from Baseline: Relationship Assessment Scale (Support Partner)
The Relationship Assessment Scale (RAS) will be used to assess the support partner's self-reported level of satisfaction with their relationship with the care recipient. The RAS will only be used in the case of non-spousal dyads. The RAS has seven items. Each item is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 1 (low) to 5 (high). Items 4 and 7 are reverse-scored. Scoring is kept continuous; the higher the score, the more satisfied the respondent is with his/her relationship.
Measured: Up to 8 months from enrollment
Change from Baseline: Modified Social Support Survey (Person with Multiple Sclerosis)
The Modified Social Support Survey (MSSS) will be used to measure the MS participant's perceived social support. The MSSS consists of 18 items. Each item presents a statement that the MS participant is asked to endorse on a 5-point scale. Response options range from 1 (none of the time) to 5 (all of the time). The MSSS has four subscales that measure different dimensions of social support, including tangible support (4 items), emotional support (8 items), affective support (3 items) and positive support (3 items).
Measured: Up to 8 months from enrollment
Change from Baseline: Burns Relationship Satisfaction Scale (Person with Multiple Sclerosis)
The Burns Relationship Satisfaction Scale will be used to assess the MS participant's self-reported level of satisfaction in various areas of the relationship with the support partner for spousal dyads. The BRSS has seven items. Each item describes a relationship area: communication and openness, conflict resolution, degree of caring and affection, intimacy and closeness, satisfaction with roles in relationship, and overall relationship satisfaction. The MS participant is asked to rate their degree of satisfaction in each of these areas. Response options range from 0 (very dissatisfied) to 6 (very satisfied).
Measured: Up to 8 months from enrollment
Change from Baseline: Relationship Assessment Scale (Person with Multiple Sclerosis)
The Relationship Assessment Scale will be used to assess the MS participant's self-reported level of satisfaction with their relationship with the support partner. The RAS will only be used in the case of non-spousal dyads. The RAS has seven items. Each item is a statement which the MS participant is asked to endorse using a 5-point scale. Response options range from 1 (low) to 5 (high). Items 4 and 7 are reverse-scored. Scoring is kept continuous; the higher the score, the more satisfied the respondent is with his/her relationship.
Measured: Up to 8 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start23 May 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healios Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Elizabeth Halstead, Healios Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555253
- Sponsor's protocol ID
- Protocol R-PILO-MSOO-010-0002
- Status last verified
- Apr 2019
- First submitted
- 14 May 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Halstead EJ, Leavitt VM, Fiore D, Mueser KT. A feasibility study of a manualized resilience-based telehealth program for persons with multiple sclerosis and their support partners. Mult Scler J Exp Transl Clin. 2020 Aug 21;6(3):2055217320941250. doi: 10.1177/2055217320941250. eCollection 2020 Jul-Sep.
PubMed 32913660
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Single-Center Study of a Manualized Resilience-Based Telehealth Program for Support Partners of Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03555253
- Acronym / sponsor ID
- Protocol R-PILO-MSOO-010-0002
- Conditions
- Multiple Sclerosis
- Keywords
- Resilience, Telehealth, Well-being, Support, Caregiving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Healios Inc.Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- 23 May 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 13 Jun 2018 (actual)
- 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.
This is a pilot feasibility study to examine the impact of providing a non-therapeutic resilience-based coaching telehealth program to the Support Partners (SP) of persons with MS (PwMS).
Cognitive difficulties are a prominent feature in PwMS and prove to be a challenge for PwMS and the close family members that care for them. This study is a pilot telehealth program that aims to address these needs and improve the overall well-being of adults with MS and their Support Partners.
A manualized program was developed utilizing the previous research study conducted literature, and the expertise and experience of the research study team. Funding was sought and obtained for 30 pairs to participate in the pilot. The 6-session program will address needs identified by this population and improve knowledge of cognition in PwMS.
Study Objectives:
Primary Objective:
To conduct an evaluation of the feasibility of the resilience program by examining:
- Recruitment (i.e. willingness to participate in program)
- Participation rates and attrition
- Participant satisfaction of the program.
Secondary Objective (Support Partner):
To assess the potential long-term benefits of the program to Support Partners of PwMS. Program benefits will be assessed using the following outcomes:
- Sense of Competencies
- Understanding of cognitive impairment in MS
- Caregiver burden
- Positive Emotions.
Secondary Objective (PwMS):
To assess the potential long-term benefits of the program to PwMS. Program benefits will be assessed using the following outcomes:
- Relationship Satisfaction
- Perceived Support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PwMS and their Support Partner | Experimental | Behavioral: Resilience-Based Program for Support Partners of PwMSSupport Partners will participate in six resilience coaching Program Sessions conducted weekly by a study resilience coach. PwMS will participate in the initial and final coaching Program Sessions with their Support Partners. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Resilience-Based Program for Support Partners of PwMSSupport Partners will participate in six resilience coaching Program Sessions conducted weekly by a study resilience coach. PwMS will participate in the initial and final coaching Program Sessions with their Support Partners. The MyHealios Resilience Program for PwMS and their Support Partners has been designed to be interactive and include skills-based activities led by the Resilience coach. This includes skills of communication, problem solving, and learning about resilience and cognition in MS. | Behavioural | PwMS and their Support Partner |
Primary outcome
Feasibility: Recruitment (i.e. willingness to participate in program)
Time frame: Up to 1 year
Recruitment will end when 30 fully evaluable Support Partner - PwMS pairs have completed the study. It is expected that approximately 45 pairs will be enrolled in order to produce the 30 fully evaluable pairs.
Feasibility: Participation rates and attrition
Time frame: Up to 1 year
Participation rates will be measured in terms of individual sessions completed. Attrition rates will be measured. Attrition or drop-out will be addressed as follows: those who drop out prior to the fourth session will be asked to complete a satisfaction questionnaire while those who drop out after the fourth session will be asked to complete post-measures and a satisfaction questionnaire.
Feasibility: Participant satisfaction of the program.
Time frame: Up to 1 year
The Intervention Evaluation Questionnaire was created by the research lead as a self-report measure of the participant's evaluation of the intervention and the individual sessions. Participants' evaluation data will be presented as totals from one five-point Likert scale, three yes/no questions and four open questions. The scale question measures satisfaction with the program on a range from 0 (not at all satisfied) to 4 (very satisfied). In addition to this evaluation of the intervention, four questions will be asked at the end of each session to the participants of that session. This includes two five-point Likert scale questions and two open ended questions. The first scale question measures satisfaction with the session on a range from 1 (not at all satisfied) to 5 (very satisfied). The second scale question measures the perceived helpfulness of the session on a range from 1 (not at all satisfied) to 5 (very satisfied).
11 secondary outcomes
Change from Baseline: Sense of Competence Questionnaire (Support Partner)
Time frame: Up to 8 months from enrollment
Change from Baseline: Connor-Davidson Resilience Scale (Support Partner)
Time frame: Up to 8 months from enrollment
Change from Baseline: Zarit Burden Interview (Support Partner)
Time frame: Up to 8 months from enrollment
Change from Baseline: Perceived Stress (Support Partner)
Time frame: Up to 8 months from enrollment
Change from Baseline: Knowledge Questionnaire (Support Partner)
Time frame: Up to 8 months from enrollment
Change from Baseline: Positive and Negative Affect Schedule (Support Partner)
Time frame: Up to 8 months from enrollment
Change from Baseline: Burns Relationship Satisfaction Scale (Support Partner)
Time frame: Up to 8 months from enrollment
Change from Baseline: Relationship Assessment Scale (Support Partner)
Time frame: Up to 8 months from enrollment
Change from Baseline: Modified Social Support Survey (Person with Multiple Sclerosis)
Time frame: Up to 8 months from enrollment
Change from Baseline: Burns Relationship Satisfaction Scale (Person with Multiple Sclerosis)
Time frame: Up to 8 months from enrollment
Change from Baseline: Relationship Assessment Scale (Person with Multiple Sclerosis)
Time frame: Up to 8 months from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Derived from this study: PubMed 32913660Halstead EJ, Leavitt VM, Fiore D, Mueser KT. A feasibility study of a manualized resilience-based telehealth program for persons with multiple sclerosis and their support partners. Mult Scler J Exp Transl Clin. 2020 Aug 21;6(3):2055217320941250. doi: 10.1177/2055217320941250. eCollection 2020 Jul-Sep.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Study of Skin Tumors in Tuberous Sclerosis
Tuberous Sclerosis
Recruiting
The Effects of Synchronous and Asynchronous Pilates Training Based on Telerehabilitation on Core Stabilization, Balance, Cognitive Functions, and Quality of Life in Individuals With Multiple Sclerosis: A Single-Blind Randomized Controlled Trial
Multiple Sclerosis
RecruitingObservational study
Care in Multiple Sclerosis (MS)
Multiple Sclerosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience-Based Program for Support Partners of PwMS in people with Multiple Sclerosis, run by Healios Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment (i.e. willingness to participate in program) (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03555253, which also lists 1 linked publication.
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 10 Apr 2019.