Alcohol Use DisorderNCT05393544
Digitally Assisted Recovery Coach
A study testing Digitally assisted peer recovery coach in people with Alcohol Use Disorder and Alcohol Withdrawal, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aims of this proof-of-concept study are to determine the feasibility of 1) using a smartphone app ("Lifeguard") to facilitate engagement with a peer recovery coach, 2) monitoring post-detox using a modified Brief Addiction Monitor, and 3) assessing linkage to care post-detox. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Withdrawal
- What is being tested?
- Digitally assisted peer recovery coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 15 May 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65
- Diagnosis of DSM-5 alcohol use disorder
- Admitted to Brigham and Women's Faulkner Hospital (BWF) inpatient Addiction Recovery Program to treat alcohol withdrawal
- Own either an iOS or Android smartphone device
- Have an active email address
- English speaking
Who cannot join
- Inability to provide informed consent due to delirium or other cognitive impairments
- Current psychosis, suicidality or homicidality
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130
About this study
Official title: Digitally Assisted Virtual Recovery Coach to Improve Inpatient Alcohol Withdrawal Management: A Proof-of-concept Pilot Study
The aims of this proof-of-concept study are to determine the feasibility of 1) using a smartphone app ("Lifeguard") to facilitate engagement with a peer recovery coach, 2) monitoring post-detox using a modified Brief Addiction Monitor, and 3) assessing linkage to care post-detox.
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal
- Being tested
- Digitally assisted peer recovery coach
- Keywords
- alcohol use disorder, peer recovery coach, smartphone app
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digitally assisted peer recovery coachBehavioural
The certified peer recovery coach utilized an existing care coordination smartphone app to provide support to the patient during and after an inpatient detoxification treatment for alcohol use disorder. The coach utilized the telephone or text messages to send daily motivational messages, remind about upcoming appointments, and checked-in if responses were concerning. Follow-up by the coach continued for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention utilizes an existing care coordination smartphone app to allow participants to engage with a recovery coach during and after an inpatient admission to an inpatient withdrawal management facility (i.e. detox). Receives: Behavioral: Digitally assisted peer recovery coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of coach engagement
The proportion and the number of days of participants engaging with the coach during and after detoxification.
Measured: 30 days
Secondary outcomes (2)
Feasibility of monitoring clinical status
The proportion and the number of days of participants responding to prompts during and after detoxification.
Measured: 30 days
Linkage to care
The proportion of participants successfully linking to care after discharge.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Nov 2021
- Primary completion1 Apr 2022
- Study completion15 May 2022
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 Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joji Suzuki, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393544
- Sponsor's protocol ID
- 2021P000731
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Suzuki J, Loguidice F, Prostko S, Szpak V, Sharma S, Vercollone L, Garner C, Ahern D. Digitally Assisted Peer Recovery Coach to Facilitate Linkage to Outpatient Treatment Following Inpatient Alcohol Withdrawal Treatment: Proof-of-Concept Pilot Study. JMIR Form Res. 2023 Jul 5;7:e43304. doi: 10.2196/43304.
PubMed 37405844
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitally Assisted Virtual Recovery Coach to Improve Inpatient Alcohol Withdrawal Management: A Proof-of-concept Pilot Study
- ClinicalTrials.gov ID
- NCT05393544
- Acronym / sponsor ID
- 2021P000731
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal
- Keywords
- alcohol use disorder, peer recovery coach, smartphone app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 26 May 2022 (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 aims of this proof-of-concept study are to determine the feasibility of 1) using a smartphone app ("Lifeguard") to facilitate engagement with a peer recovery coach, 2) monitoring post-detox using a modified Brief Addiction Monitor, and 3) assessing linkage to care post-detox.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Digitally assisted peer recovery coachThe intervention utilizes an existing care coordination smartphone app to allow participants to engage with a recovery coach during and after an inpatient admission to an inpatient withdrawal management facility (i.e. detox). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 65
- Diagnosis of DSM-5 alcohol use disorder
- Admitted to Brigham and Women's Faulkner Hospital (BWF) inpatient Addiction Recovery Program to treat alcohol withdrawal
- Own either an iOS or Android smartphone device
- Have an active email address
Key exclusion criteria (2 listed)
- Inability to provide informed consent due to delirium or other cognitive impairments
- Current psychosis, suicidality or homicidality
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 |
|---|---|---|
| Digitally assisted peer recovery coachThe certified peer recovery coach utilized an existing care coordination smartphone app to provide support to the patient during and after an inpatient detoxification treatment for alcohol use disorder. The coach utilized the telephone or text messages to send daily motivational messages, remind about upcoming appointments, and checked-in if responses were concerning. Follow-up by the coach continued for 30 days. | Behavioural | Intervention |
Primary outcome
Feasibility of coach engagement
Time frame: 30 days
The proportion and the number of days of participants engaging with the coach during and after detoxification.
2 secondary outcomes
Feasibility of monitoring clinical status
Time frame: 30 days
Linkage to care
Time frame: 30 days
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 26 May 2022.
- Derived from this study: PubMed 37405844Suzuki J, Loguidice F, Prostko S, Szpak V, Sharma S, Vercollone L, Garner C, Ahern D. Digitally Assisted Peer Recovery Coach to Facilitate Linkage to Outpatient Treatment Following Inpatient Alcohol Withdrawal Treatment: Proof-of-Concept Pilot Study. JMIR Form Res. 2023 Jul 5;7:e43304. doi: 10.2196/43304.
- Individual participant dataSharing planned: No
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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 Digitally assisted peer recovery coach in people with Alcohol Use Disorder and Alcohol Withdrawal, run by Brigham and Women's Hospital 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 26 May 2022. 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 of coach engagement (time frame: 30 days). 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 NCT05393544, 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 26 May 2022.