Cognitive ImpairmentNCT04426838
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
A study testing Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference in people with Cognitive Impairment and Dementia, run by Emory University at 2 sites in United States.
Trial summary
Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to earlier placement of the PLwD in nursing homes and increase the risk for many psychological and cognitive health issues and poor quality of life for both the PLwD and the caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Dementia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2020to 10 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregiver-reported diagnosis of cognitive impairment and Alzheimer's disease and related dementias (ADRD)
- Co-residence with the caregiver in the community
- Montreal Cognitive Assessment (MOCA) score between 12 and 25
- Stable dose of psychotropic medications, anti-dementia, sedatives/hypnotics, or opioids in the past 90 days
- Presence of sleep problems determined by using the proxy-rated Sleep Disorders Inventory (presence of at least one sleep disturbance symptom of moderate severity)
- Informal caregivers (family/friends) of co-residing PLwD
Show all 11Show fewer
- Providing unpaid assistance, on average 20 hours weekly, for a person in the early stage of illness who is community-dwelling
- Presence of sleep problems: sleep onset latency or wake after sleep onset more than 30 minutes more than 3 nights weekly
- Tolerate and agrees to wear wrist actigraph
- Be able to read, speak and understand English
- Have no uncorrectable vision or hearing deficits that might impede participation
Who cannot join
- None
- Moderate to severe cognitive impairment defined as MoCA score <17
- Current sedative-hypnotic or other sleep aid use on a regular or as needed schedule within the prior three months
- Presence of an acute medical or psychiatric condition which would interfere with the subject's ability to realistically follow the study protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University
Atlanta, Georgia, 30322
Goizueta Alzheimer's Disease Research Center
Atlanta, Georgia, 30329
About this study
Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to earlier placement of the PLwD in nursing homes and increase the risk for many psychological and cognitive health issues and poor quality of life for both the PLwD and the caregivers. Given the potential harmful side effects of medications, non-medication alternatives, such as Cognitive Behavioral Therapy for Insomnia (CBTi), may be safer to improve disturbed sleep in this population. CBTi which includes stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has durable and sustained effects on sleep outcomes over the long-term. CBTi has improved sleep disturbances in PLwD and their caregivers, separately. Since disturbed sleep in the PLwD-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for intervention has the potential to lead to improved sleep and health outcomes for both persons. There is no current published research on CBTi when the PLwD and their caregivers receive the intervention at the same time; as a result, the researchers will examine the 1) feasibility; 2) acceptability; and 3) preliminary efficacy of 4-week CBTi intervention for community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances. Forty PLwD-caregiver dyads will receive CBTi via videoconferencing sessions. Preliminary efficacy of the intervention will be assessed using objective (actigraphy) and subjective sleep quality measures. In addition, semi-structured interviews will be conducted to examine the acceptability and satisfaction with the intervention.
Read the detailed description
Up to 71% of the persons living with dementia (PLwD) and 70% of their caregivers experience sleep disturbances, which are distressing for both the PLwD and their caregivers. Specifically, PLwD often experience restlessness and fragmented sleep, which in turn can affect caregivers' sleep patterns leading to multiple nightly awakenings, shorter sleep duration, and/or inconsistent sleep-wake times. These disturbances increase the risk for a myriad of psychological, cognitive, behavioral, and physiological health issues and poor quality of life for the dyad. Given the interdependence of the dyadic sleep disturbances and the negative health consequences of sleep disturbances on the dyad, there is a critical need to develop and provide effective interventions to improve their sleep. Pharmacologic treatment often results in potential harmful side effects like falls and cognitive decline; therefore, non-pharmacologic approaches are recommended for this population.
Cognitive behavioral therapy for insomnia (CBTi), a non-pharmacologic intervention that has demonstrated effectiveness for improving sleep disturbances in multiple populations, is delivered in various formats including face-to-face and videoconferencing. Individually, PLwD and caregivers have successfully deployed behavioral sleep techniques, resulting in improved sleep quality. However, there is no current published research on CBTi completed simultaneously by the PLwD-caregiver dyad, and that is exactly what the researchers of this study seek to do with early-stage individuals and their caregivers. The researchers premise this effort on the notion that a dyadic intervention can use early-stage individuals' retained capacity for communication and comprehension to establish in-the-moment agreements about strategies the caregiver can employ to enact and facilitate positive sleep behaviors in the PLwD and to pair that with acquired strategies to engender his/her own positive sleep behaviors.
This project seeks to gather formative and preliminary data on CBTi delivered simultaneously to the PLwD-caregiver dyad. The researchers will use a quantitative, descriptive approach to determine the feasibility, acceptability, and preliminary efficacy of a 4-session CBTi intervention administered to 40 PLwD-caregiver dyads via videoconferencing sessions who will receive the intervention as a unit. Objective and subjective sleep, depressive symptoms, and cognitive health data will be collected at baseline, and 1 week and 3 months post-completion of the intervention.
In community-dwelling PLwD and their caregivers where both persons in the dyad self-report sleep disturbances, the specific aims for this study are:
- Assess the feasibility of a video conferencing dyad-based CBTi intervention.
- Evaluate the acceptability of a video conferencing dyad-based CBTi intervention.
- Examine the preliminary efficacy of video conferencing CBTi intervention on sleep quality outcomes including sleep efficiency and perceived sleep quality.
- Conditions
- Cognitive Impairment, Dementia
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference
- Keywords
- Cognitive behavioral therapy for insomnia, Insomnia, Caregiver, Cognitive impairment
- Medical subject headings
- Cognitive Dysfunction, Dementia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBTi) via VideoconferenceBehavioural
The CBTi protocol will include stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring which will be done over 4 weeks with one session weekly delivered via videoconference.
| Study group | Role | What they receive |
|---|---|---|
| PLwD Cognitive Behavioral Therapy for Insomnia (CBTi) | Experimental | Persons living with dementia in a dyad receiving the CBTi intervention in a videoconferencing format. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference |
| Caregiver Cognitive Behavioral Therapy for Insomnia (CBTi) | Experimental | Caregivers in a dyad receiving the CBTi intervention in a videoconferencing format. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adherence with Study Interventions
Feasibility of the interventions will be assessed with rates of adherence to the study components weekly and over the 4 weeks
Measured: Weeks 1, 2, 3, 4
Percent Attrition from the Study
Feasibility of the interventions will be assessed with the percent of participants leaving the study over the 4 week intervention.
Measured: Week 4
Acceptability the Intervention
Acceptability of the interventions will be assessed with a qualitative interview with caregivers after completing the intervention. There is not a summary score for the open-ended questions asked during the interview.
Measured: Week 5 (1 week post-intervention)
Secondary outcomes (12)
Change in Sleep Disorders Inventory (SDI) - Frequency Score
The SDI asks caretakers to report the frequency that eight symptoms of insomnia have been exhibited by the PLwD in the past two weeks. Responses range from 0 to 4 where 0 = not present and 4 = every night. Total frequency scores range from 0 to 32 with higher scores indicating more frequent symptoms of insomnia.
Measured: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
Change in Sleep Disorders Inventory (SDI) - Severity Score
The SDI asks caretakers to report the severity of eight symptoms of insomnia being exhibited by the PLwD in the past two weeks. Responses range from 0 to 3 where 0 = not present and 3 = marked. Total frequency scores range from 0 to 24 with higher scores indicating more severe symptoms of insomnia.
Measured: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
Change in Sleep Disorders Inventory (SDI) - Caregiver Distress Score
The SDI asks caretakers to report the amount of distress they are experiencing due to eight symptoms of insomnia being exhibited by the PLwD in the past two weeks. Responses range from 0 to 5 where 0 = not at all and 5 = extremely. Total frequency scores range from 0 to 40 with higher scores indicating more severe caregiver distress.
Measured: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
Change in Insomnia Severity Index Score
The Insomnia Severity Index includes 7 questions asking about insomnia during the past two weeks. Responses are given on a scale from 0 to 4 where 0 = no problems and 4 = the most extreme problems. Total scores range from 0 to 28 where higher scores indicate greater problems with insomnia.
Measured: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
Change in 12-Item Short Form-12 (SF-12v2) Health Survey Score
The SF-12 Health Survey includes 12 items asking respondents how they have been feeling and activities they are doing. Physical and mental health composite scores are computed and range from 0 to 100 where 100 is the highest level of health. The computed composite scores can be compared with a national norm with a mean of 50 and a standard deviation of 10.
Measured: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score
The CES-D includes 20 items asking respondents how frequently they felt symptoms of depression during the past week. Responses are given on a scale from 0 to 3 where 0 = rarely or none of the time and 3 = most or all of the time. Certain items are reverse scored so that lower scores equate to lower symptom frequency. Total scores range from 0 to 60 with higher scores indicating greater symptoms of depression.
Measured: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
Change in Sleep Duration
Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Sleep duration (minutes per night) will be assessed with actigraphy.
Measured: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
Change in Sleep Fragmentation Index
Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. The sleep fragmentation index (number of awakenings and sleep stage shifts divided by sleep time) will be assessed with actigraphy.
Measured: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
Change in Sleep Onset Latency
Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Sleep onset latency (the length of time, in minutes, that it takes to transition from wakefulness to sleep) will be assessed with actigraphy.
Measured: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
Change in Wake After Sleep Onset
Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Wake after sleep onset (periods of wakefulness occurring after sleep onset) will be assessed with actigraphy.
Measured: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
Change in Bed Time
Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Bed time will be assessed with actigraphy.
Measured: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
Change in Wake Time
Participants will wear an actigraph for two weeks before the intervention starts and for the duration of the intervention. Wake time will be assessed with actigraphy.
Measured: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start30 Sep 2020
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 40 dyads of people living with dementia (PLwD) and their caregivers will be enrolled to participate in the behavioral intervention together.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Principal investigator, Glenna Brewster, Emory University
- Investigators
- Glenna Brewster, PhD, RN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426838
- Sponsor's protocol ID
- IRB00115210
- Status last verified
- Mar 2023
- First submitted
- 9 Jun 2020
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
- ClinicalTrials.gov ID
- NCT04426838
- Acronym / sponsor ID
- IRB00115210
- Conditions
- Cognitive Impairment, Dementia
- Keywords
- Cognitive behavioral therapy for insomnia, Insomnia, Caregiver, Cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 11 Jun 2020 (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.
Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to earlier placement of the PLwD in nursing homes and increase the risk for many psychological and cognitive health issues and poor quality of life for both the PLwD and the caregivers. Given the potential harmful side effects of medications, non-medication alternatives, such as Cognitive Behavioral Therapy for Insomnia (CBTi), may be safer to improve disturbed sleep in this population. CBTi which includes stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has durable and sustained effects on sleep outcomes over the long-term. CBTi has improved sleep disturbances in PLwD and their caregivers, separately. Since disturbed sleep in the PLwD-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for intervention has the potential to lead to improved sleep and health outcomes for both persons. There is no current published research on CBTi when the PLwD and their caregivers receive the intervention at the same time; as a result, the researchers will examine the 1) feasibility; 2) acceptability; and 3) preliminary efficacy of 4-week CBTi intervention for community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances. Forty PLwD-caregiver dyads will receive CBTi via videoconferencing sessions. Preliminary efficacy of the intervention will be assessed using objective (actigraphy) and subjective sleep quality measures. In addition, semi-structured interviews will be conducted to examine the acceptability and satisfaction with the intervention.
Detailed description
Up to 71% of the persons living with dementia (PLwD) and 70% of their caregivers experience sleep disturbances, which are distressing for both the PLwD and their caregivers. Specifically, PLwD often experience restlessness and fragmented sleep, which in turn can affect caregivers' sleep patterns leading to multiple nightly awakenings, shorter sleep duration, and/or inconsistent sleep-wake times. These disturbances increase the risk for a myriad of psychological, cognitive, behavioral, and physiological health issues and poor quality of life for the dyad. Given the interdependence of the dyadic sleep disturbances and the negative health consequences of sleep disturbances on the dyad, there is a critical need to develop and provide effective interventions to improve their sleep. Pharmacologic treatment often results in potential harmful side effects like falls and cognitive decline; therefore, non-pharmacologic approaches are recommended for this population.
Cognitive behavioral therapy for insomnia (CBTi), a non-pharmacologic intervention that has demonstrated effectiveness for improving sleep disturbances in multiple populations, is delivered in various formats including face-to-face and videoconferencing. Individually, PLwD and caregivers have successfully deployed behavioral sleep techniques, resulting in improved sleep quality. However, there is no current published research on CBTi completed simultaneously by the PLwD-caregiver dyad, and that is exactly what the researchers of this study seek to do with early-stage individuals and their caregivers. The researchers premise this effort on the notion that a dyadic intervention can use early-stage individuals' retained capacity for communication and comprehension to establish in-the-moment agreements about strategies the caregiver can employ to enact and facilitate positive sleep behaviors in the PLwD and to pair that with acquired strategies to engender his/her own positive sleep behaviors.
This project seeks to gather formative and preliminary data on CBTi delivered simultaneously to the PLwD-caregiver dyad. The researchers will use a quantitative, descriptive approach to determine the feasibility, acceptability, and preliminary efficacy of a 4-session CBTi intervention administered to 40 PLwD-caregiver dyads via videoconferencing sessions who will receive the intervention as a unit. Objective and subjective sleep, depressive symptoms, and cognitive health data will be collected at baseline, and 1 week and 3 months post-completion of the intervention.
In community-dwelling PLwD and their caregivers where both persons in the dyad self-report sleep disturbances, the specific aims for this study are:
- Assess the feasibility of a video conferencing dyad-based CBTi intervention.
- Evaluate the acceptability of a video conferencing dyad-based CBTi intervention.
- Examine the preliminary efficacy of video conferencing CBTi intervention on sleep quality outcomes including sleep efficiency and perceived sleep quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 40 dyads of people living with dementia (PLwD) and their caregivers will be enrolled to participate in the behavioral intervention together.
| Arm | Type | Receives |
|---|---|---|
| PLwD Cognitive Behavioral Therapy for Insomnia (CBTi) | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi) via VideoconferencePersons living with dementia in a dyad receiving the CBTi intervention in a videoconferencing format. |
| Caregiver Cognitive Behavioral Therapy for Insomnia (CBTi) | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTi) via VideoconferenceCaregivers in a dyad receiving the CBTi intervention in a videoconferencing format. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Caregiver-reported diagnosis of cognitive impairment and Alzheimer's disease and related dementias (ADRD)
- Co-residence with the caregiver in the community
- Montreal Cognitive Assessment (MOCA) score between 12 and 25
- Stable dose of psychotropic medications, anti-dementia, sedatives/hypnotics, or opioids in the past 90 days
- Presence of sleep problems determined by using the proxy-rated Sleep Disorders Inventory (presence of at least one sleep disturbance symptom of moderate severity)
Key exclusion criteria (4 listed)
- None
- Moderate to severe cognitive impairment defined as MoCA score <17
- Current sedative-hypnotic or other sleep aid use on a regular or as needed schedule within the prior three months
- Presence of an acute medical or psychiatric condition which would interfere with the subject's ability to realistically follow the study protocol
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 |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBTi) via VideoconferenceThe CBTi protocol will include stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring which will be done over 4 weeks with one session weekly delivered via videoconference. | Behavioural | Caregiver Cognitive Behavioral Therapy for Insomnia (CBTi), PLwD Cognitive Behavioral Therapy for Insomnia (CBTi) |
Primary outcome
Change in Adherence with Study Interventions
Time frame: Weeks 1, 2, 3, 4
Feasibility of the interventions will be assessed with rates of adherence to the study components weekly and over the 4 weeks
Percent Attrition from the Study
Time frame: Week 4
Feasibility of the interventions will be assessed with the percent of participants leaving the study over the 4 week intervention.
Acceptability the Intervention
Time frame: Week 5 (1 week post-intervention)
Acceptability of the interventions will be assessed with a qualitative interview with caregivers after completing the intervention. There is not a summary score for the open-ended questions asked during the interview.
12 secondary outcomes
Change in Sleep Disorders Inventory (SDI) - Frequency Score
Time frame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
Change in Sleep Disorders Inventory (SDI) - Severity Score
Time frame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
Change in Sleep Disorders Inventory (SDI) - Caregiver Distress Score
Time frame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
Change in Insomnia Severity Index Score
Time frame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
Change in 12-Item Short Form-12 (SF-12v2) Health Survey Score
Time frame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score
Time frame: Baseline, Week 5 (1 week post-intervention), Month 4 (1 month post-intervention)
Change in Sleep Duration
Time frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
Change in Sleep Fragmentation Index
Time frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
Change in Sleep Onset Latency
Time frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
Change in Wake After Sleep Onset
Time frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
Change in Bed Time
Time frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
Change in Wake Time
Time frame: Baseline (for two weeks prior to the intervention), Day 1 through Week 4
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 20 Mar 2023.
- 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.
Glenna Brewster, PhD, RN principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference in people with Cognitive Impairment and Dementia, run by Emory University at 2 sites 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 11 inclusion and 4 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 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in Adherence with Study Interventions (time frame: Weeks 1, 2, 3, 4). 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?
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 20 Mar 2023.