Vaccine HesitancyNCT05167422
Trusted Messenger Intervention
A study testing Trusted Messenger in people with Vaccine Hesitancy, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The objective of this pilot study is to develop and evaluate test a trusted messenger intervention targeting vaccine hesitancy in patients on an inpatient psychiatric hospital setting with both acute and chronic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaccine Hesitancy
- What is being tested?
- Trusted Messenger
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2021to 14 Jul 2023
- 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
- Able and willing to give verbal informed consent to participate in the study or able to assent with guardian consent
- Expected to remain in the hospital for the duration of the study
- Mental health diagnosis Demographics
- Male, female, or transgender (no exclusion criteria based on gender or sexual orientation)
- Ages 18 or older
- Any race or ethnicity
- English speaking
Who cannot join
- Cognitive impairment sufficient to interfere with participant's ability to provide assent
- People who are non-English speakers or who have major visual or hearing impairment will be excluded given the need to converse with the Trusted Messenger verbally
- People who have received any of the available forms of the COVID-19 vaccine, or those with a medical exemption for receiving the vaccine.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Hampshire Hospital
Concord, New Hampshire, 03301
About this study
Official title: Preliminary Study of a Trusted Messenger Intervention to Promote Vaccine Uptake in Adult Inpatient Psychiatric Hospitals
The objective of this pilot study is to develop and evaluate test a trusted messenger intervention targeting vaccine hesitancy in patients on an inpatient psychiatric hospital setting with both acute and chronic patients.
- Conditions
- Vaccine Hesitancy
- Being tested
- Trusted Messenger
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trusted MessengerBehavioural
A nested waitlist design in which patients and staff are nested within two inpatient psychiatric units. New Hampshire Hospital staff will be trained to deliver the trusted messenger intervention up to 24 patients on the first unit while the second unit receives care as usual, during which time in-house vaccinations among patients on both units will be tracked in a registry. After a 3-week study period, up to 24 patients on the second unit will receive the trusted messenger intervention and followed for a period of 3 weeks. The trusted messenger intervention will consist of staff who are trained to engage patients informally and assist building social norms for vaccine uptake supported by weekly and as-needed check-ins with a content expert who can answer specific vaccine related questions over a 3 week period.
| Study group | Role | What they receive |
|---|---|---|
| Trusted Messenger | Experimental | The trusted messenger patient intervention will involve training a small number of staff "trusted messengers" to engage patients informally and assist with building vaccine confidence in brief one- on-one sessions, supported by trusted messengers weekly consultations with a content expert who can answer specific vaccine related questions that patients have over a 3-week period. Trusted messengers will be full time unit employees, selected with the assistance of the nursing supervisor for having excellent rapport with patients (assessed with the Nurse Coordinator Questionnaire) and for having been vaccinated. Mental health workers or nurses may serve in this role. Both inpatient units involved in this study will be grouped into the same vaccination cohort within the hospital, to provide patients in the intervention and the wait list similar opportunities to be vaccinated. Receives: Behavioral: Trusted Messenger |
| Standard Care | No intervention | After a 3-week study period, up to 24 patients on the second unit will receive the trusted messenger intervention and followed for a period of 3 weeks. The trusted messenger intervention will consist of staff who are trained to engage patients informally and assist building social norms for vaccine uptake supported by weekly and as-needed check-ins with a content expert who can answer specific vaccine related questions over a 3 week period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine acceptance- This will be measured using the COVID Vaccine Hesitancy Questionnaire
The participant is willing to receive the COVID-19 vaccine
Measured: Participant is willing to receive the vaccine by the end of week 6 of participation from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start14 Sep 2021
- Primary completion14 Jul 2023
- Study completion14 Jul 2023
Why it stopped: Inability to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine HesitancyStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Nested quasi-experimental
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey C. Fetter, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167422
- Sponsor's protocol ID
- 02001055
- Status last verified
- Jul 2023
- First submitted
- 5 Oct 2021
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of a Trusted Messenger Intervention to Promote Vaccine Uptake in Adult Inpatient Psychiatric Hospitals
- ClinicalTrials.gov ID
- NCT05167422
- Acronym / sponsor ID
- 02001055
- Conditions
- Vaccine Hesitancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 22 Dec 2021 (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.
The objective of this pilot study is to develop and evaluate test a trusted messenger intervention targeting vaccine hesitancy in patients on an inpatient psychiatric hospital setting with both acute and chronic patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Nested quasi-experimental
| Arm | Type | Receives |
|---|---|---|
| Trusted Messenger | Experimental | Behavioral: Trusted MessengerThe trusted messenger patient intervention will involve training a small number of staff "trusted messengers" to engage patients informally and assist with building vaccine confidence in brief one- on-one sessions, supported by trusted messengers weekly consultations with a content expert who can answer specific vaccine related questions that patients have over a 3-week period. Trusted messengers will be full time unit employees, selected with the assistance of the nursing supervisor for having excellent rapport with patients (assessed with the Nurse Coordinator Questionnaire) and for having been vaccinated. Mental health workers or nurses may serve in this role. Both inpatient units involved in this study will be grouped into the same vaccination cohort within the hospital, to provide patients in the intervention and the wait list similar opportunities to be vaccinated. |
| Standard Care | No intervention | –After a 3-week study period, up to 24 patients on the second unit will receive the trusted messenger intervention and followed for a period of 3 weeks. The trusted messenger intervention will consist of staff who are trained to engage patients informally and assist building social norms for vaccine uptake supported by weekly and as-needed check-ins with a content expert who can answer specific vaccine related questions over a 3 week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able and willing to give verbal informed consent to participate in the study or able to assent with guardian consent
- Expected to remain in the hospital for the duration of the study
- Mental health diagnosis Demographics
- Male, female, or transgender (no exclusion criteria based on gender or sexual orientation)
- Ages 18 or older
Key exclusion criteria (3 listed)
- Cognitive impairment sufficient to interfere with participant's ability to provide assent
- People who are non-English speakers or who have major visual or hearing impairment will be excluded given the need to converse with the Trusted Messenger verbally
- People who have received any of the available forms of the COVID-19 vaccine, or those with a medical exemption for receiving the vaccine.
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 |
|---|---|---|
| Trusted MessengerA nested waitlist design in which patients and staff are nested within two inpatient psychiatric units. New Hampshire Hospital staff will be trained to deliver the trusted messenger intervention up to 24 patients on the first unit while the second unit receives care as usual, during which time in-house vaccinations among patients on both units will be tracked in a registry. After a 3-week study period, up to 24 patients on the second unit will receive the trusted messenger intervention and followed for a period of 3 weeks. The trusted messenger intervention will consist of staff who are trained to engage patients informally and assist building social norms for vaccine uptake supported by weekly and as-needed check-ins with a content expert who can answer specific vaccine related questions over a 3 week period. | Behavioural | Trusted Messenger |
Primary outcome
Vaccine acceptance- This will be measured using the COVID Vaccine Hesitancy Questionnaire
Time frame: Participant is willing to receive the vaccine by the end of week 6 of participation from baseline.
The participant is willing to receive the COVID-19 vaccine
Results and safety
The study was stopped early (reason given: Inability to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Vaccine Hesitancy
Recruiting
Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP)
Acute Coronary Syndrome, Heart Failure
Not yet recruiting
Development and Evaluation of a Digital Educational Intervention to Improve Vaccine Confidence and Communication Among Registered Nurses: Protocol for a Randomized Controlled Trial (VaxNurse-RCT).
Vaccine Hesitancy, Vaccine Acceptance
Active, not recruiting
Communication Strategies to Increase HPV Vaccinations
Papilloma Viral Infection, Vaccine Hesitancy
Not yet recruiting
Evaluation of a Vaccine Chatbot on HPV Vaccine Confidence and Hesitancy
HPV Vaccine
Not yet recruiting
Parents' Knowledge and Attitudes Towards Vaccinating Their Children
Vaccine Hesitancy
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 Trusted Messenger in people with Vaccine Hesitancy, run by Dartmouth-Hitchcock Medical Center 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?
The sponsor lists 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 17 Jul 2023. 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 was stopped early (reason given: Inability to recruit). Results are not available in the source record.
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?
Vaccine acceptance- This will be measured using the COVID Vaccine Hesitancy Questionnaire (time frame: Participant is willing to receive the vaccine by the end of week 6 of participation from baseline.). 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 17 Jul 2023.