Diabetes MellitusCHRONICLENCT05955339
Comparing Healthcare Visit Recording and Open Notes to Improve Chronic iLlness Care Experience in Older Adults
A study testing NOTES and AUDIO in people with Diabetes Mellitus and Hypertension, run by Dartmouth-Hitchcock Medical Center at 3 sites in United States.
Trial summary
CHRONICLE is a randomized trial assessing the comparative effectiveness of providing written visit information via the patient portal (NOTES) versus NOTES plus visit audio recording (AUDIO) to older adult patients with chronic diseases on quality of life and other outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Hypertension
- What is being tested?
- NOTES and AUDIO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,022 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Jan 2024to 14 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≥ 65 years;
- With multimorbidity (diabetes or hypertension plus one of the following: arthritis (osteoarthritis and rheumatoid arthritis), asthma, atrial fibrillation, Alzheimer's disease and related dementia (not severe), cancer, chronic obstructive pulmonary disease, depression, heart disease, heart failure, hyperlipidemia, osteoporosis, kidney disease and stroke. Patients with diabetes plus hypertension are eligible.
- Have had two or more clinic visits in the previous 12 months;
- Plan on receiving ongoing care at the clinic with the enrolled clinician for the subsequent 6 months;
- Do not have vision or hearing problems that cannot be corrected; and
- Have not recorded a clinic visit for personal use in the past 6 months
Show all 10Show fewer
- Agree to their identified role as a caregiver;
- Speak English or Spanish;
- Have capacity to consent to research participation; and
- ≥ 18 years.
Who cannot join
- With no capacity to consent to the project;
- With schizophrenia and other psychotic disorders, current substance-use disorders, uncorrected hearing or visual impairment with no adjustments to support accessing the interventions or surveys;
- Living in skilled nursing homes or hospice, because they engage less in self-management;
- With cognitive impairment as identified by a score of ≤4 on the six-item screener (SIS)
- Lacking internet access;
- Who do not speak English or Spanish;
Show all 13Show fewer
- Who (i) do not have access to a personal email, (ii) do not have an email address shared with a family member or patient-identified caregiver, and/or (iii) are not interested in creating a personal email as this would prevent them from engaging with the intervention(s); and
- Who do not wish to create a patient portal account, if they do not already have one as this would prevent them from engaging with the intervention(s).
- CAREGIVERS:
- No capacity to consent to the project;
- Living in skilled nursing homes or hospice;
- Lacking internet access; or
- Do not speak English or Spanish
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
University of Texas Medical Branch
Galveston, Texas, 77555
Meredith C Masel, PhD, 409-747-6009, mcmasel@utmb.edu
Isamar Ortiz, 409-266-3009, iiortiz@utmb.edu
- Recruiting
Dartmouth Hitchcock Clinics Manchester
Manchester, New Hampshire, 03104
Paul J Bar, PhD, 603-646-7016, paul.j.barr@dartmouth.edu
Renata W Yen, PhD, 603-646-5670, renata.west.yen@dartmouth.edu
- Recruiting
Vanderbit University Medical Center
Nashville, Tennessee, 37232
Kerri L Cavanaugh, MD, 615-875-2737, kerri.cavanaugh@vumc.org
Sonya Williams, 615 875 2737, sonya.I.williams@vumc.org
About this study
Official title: Comparing Healthcare Visit Recording and Open Notes to Improve the Chronic Illness Care Experience for Older Adults (The CHRONICLE Trial)
CHRONICLE is a randomized trial assessing the comparative effectiveness of providing written visit information via the patient portal (NOTES) versus NOTES plus visit audio recording (AUDIO) to older adult patients with chronic diseases on quality of life and other outcomes. During the trial, the team will also invite caregivers identified by patients to join the project.
Read the detailed description
The research team is working with primary care clinics at three health systems across the country to enroll adults ages 65 and older who are managing diabetes or high blood pressure, plus one other disease. The team is assigning patients by chance to one of two groups. Each group will have an equal numbers of patients. Patients in one group will get access to visit notes through the patient portal. The research team will give patients guidance on how to find and use their visit notes. Patients in the other group will not only have access to their visit notes patients but also get access to audio-recordings of their visits. After each visit, patients in both groups will receive emails to review their visit information: 1) two days after their visit to remind them of their visit discussion and any tasks they may have, and 2) three days before their next visit, they will be asked to think of any changes from their last visit and to make a list of three things they want to talk to their doctor about. The team is comparing changes reported by patients over six months in quality of life, satisfaction, self-management ability, treatment adherence, and visit communication. The team will also invite caregivers identified by patients to join the project. They will show patients how to share their visit notes or recordings with caregivers. Caregivers will report on changes in how prepared they feel to provide care, burden related to caregiving, and how much they felt part of the patient's visit conversation.
- Conditions
- Diabetes Mellitus, Hypertension
- Being tested
- NOTES, AUDIO
- Keywords
- Audio Recording, Diabetes Mellitus, Hypertension, Patient-centered communication, Self-management, Older adults, Chronic conditions, After visit summary, Quality of life, Multimorbidity
- Medical subject headings
- Diabetes Mellitus, Hypertension, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOTESOther
The intervention will include: (1) a brief training on using the patient portal to access written visit information with assistance in setting up patient portal accounts where necessary (including strategies to share notes with a caregiver), (2) post-visit reminders to use the patient portal to access written visit information.
AUDIOOther
The intervention will include: (1) audio recording all visits with the study clinician for six months, (2) training on how to record visits and access visit recordings, and (3) post-visit reminders listen to the visit recordings.
| Study group | Role | What they receive |
|---|---|---|
| NOTES | Active comparator | Patients in this arm will receive only the NOTES intervention. Receives: Other: NOTES |
| NOTES + AUDIO | Active comparator | Patients in this arm will receive both the NOTES and AUDIO intervention. Receives: Other: NOTES; Other: AUDIO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life - Mental functioning
Quality of life using Global PROMIS (Patient-Reported Outcome Measurement Information System) is a 10-item patient reported measure with two domains: mental and physical health. Domain scores range from 4 to 20, with higher scores representing better health.
Measured: 6 months from enrollment
Quality of Life - Physical functioning
Quality of life using Global PROMIS (Patient-Reported Outcome Measurement Information System) is a 10-item patient reported measure with two domains: mental and physical health. Domain scores range from 4 to 20, with higher scores representing better health.
Measured: 6 months from enrollment
Secondary outcomes (4)
Self-management ability
Self-management ability using the Patient Activation Measure-Short Form is a 13-item patient reported measure. Scores are range from 0 (low activation) to 100 (high activation).
Measured: 6 months from enrollment
Medication adherence
Medication adherence using Adherence to Refills and Medications (ARMS-7), an seven-item measure with two domains: i) medication taking and ii) medication refilling. ARMS-7 scores range from 7 (high adherence) to 28 (low adherence).
Measured: 6 months from enrollment
General satisfaction
General satisfaction using the two-item general satisfaction sub-scale from the Patient Satisfaction Questionnaire-18 (PSQ-18). The subscale is scored as a mean of the two questions with a potential score ranging from 1 to 5. Higher scores indicate more satisfaction.
Measured: 6 months from enrollment
Visit communication style and shared decision-making
Visit communication style and shared decision making using 14 items (6 of 7 subscales) from the Interpersonal Process of Care (IPC) survey. Each of the 6 subscales has a potential score of 1 to 5. Direction of the score depends on the subscale.
Measured: 6 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 posted21 Jul 2023
- Study start24 Jan 2024
- Primary completion7 Apr 2027 (estimated)
- Study completion14 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated to NOTES or NOTES+AUDIO using a block randomization technique with the clinician acting as the blocking variable. This strategy will ensure an equal number of patients per clinician will be randomly assigned to each study arm.
- Masking
- None (open label)
- Enrolment
- 1,022 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Medical Branch, Galveston, Vanderbilt University Medical Center, Beth Israel Deaconess Medical Center, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Paul J. Barr, Trustees of Dartmouth College
- Investigators
- Paul J Barr, PhD, Principal investigator, Dartmouth CollegeKerri L Cavanaugh, MD, Principal investigator, Vanderbilit University Medical CenterMeredith C Masel, PhD, Principal investigator, University Texas Medical Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955339
- Sponsor's protocol ID
- STUDY02002056
- Acronym
- CHRONICLE
- Status last verified
- May 2026
- First submitted
- 12 Jul 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of this research, the research data from this project will be deposited with the Patient-Centered Outcomes Data Repository (PCODR), based at the Inter-university Consortium for Political and Social Research (ICPSR), University of Michigan to ensure that the research community has long-term access to the data. This will include all deidentified data from surveys and/or transcripts from recorded interviews or encounters. For those who consent, we will also put identifiable recordings into the repository.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Healthcare Visit Recording and Open Notes to Improve the Chronic Illness Care Experience for Older Adults (The CHRONICLE Trial)
- ClinicalTrials.gov ID
- NCT05955339
- Acronym / sponsor ID
- CHRONICLE / STUDY02002056
- Conditions
- Diabetes Mellitus, Hypertension
- Keywords
- Audio Recording, Diabetes Mellitus, Hypertension, Patient-centered communication, Self-management, Older adults, Chronic conditions, After visit summary
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,022 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- The University of Texas Medical Branch, Galveston, Vanderbilt University Medical Center, Beth Israel Deaconess Medical Center, Patient-Centered Outcomes Research Institute
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 14 Jun 2027 (estimated)
- First posted
- 21 Jul 2023 (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.
CHRONICLE is a randomized trial assessing the comparative effectiveness of providing written visit information via the patient portal (NOTES) versus NOTES plus visit audio recording (AUDIO) to older adult patients with chronic diseases on quality of life and other outcomes. During the trial, the team will also invite caregivers identified by patients to join the project.
Detailed description
The research team is working with primary care clinics at three health systems across the country to enroll adults ages 65 and older who are managing diabetes or high blood pressure, plus one other disease. The team is assigning patients by chance to one of two groups. Each group will have an equal numbers of patients. Patients in one group will get access to visit notes through the patient portal. The research team will give patients guidance on how to find and use their visit notes. Patients in the other group will not only have access to their visit notes patients but also get access to audio-recordings of their visits. After each visit, patients in both groups will receive emails to review their visit information: 1) two days after their visit to remind them of their visit discussion and any tasks they may have, and 2) three days before their next visit, they will be asked to think of any changes from their last visit and to make a list of three things they want to talk to their doctor about. The team is comparing changes reported by patients over six months in quality of life, satisfaction, self-management ability, treatment adherence, and visit communication. The team will also invite caregivers identified by patients to join the project. They will show patients how to share their visit notes or recordings with caregivers. Caregivers will report on changes in how prepared they feel to provide care, burden related to caregiving, and how much they felt part of the patient's visit conversation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated to NOTES or NOTES+AUDIO using a block randomization technique with the clinician acting as the blocking variable. This strategy will ensure an equal number of patients per clinician will be randomly assigned to each study arm.
| Arm | Type | Receives |
|---|---|---|
| NOTES | Active comparator | Other: NOTESPatients in this arm will receive only the NOTES intervention. |
| NOTES + AUDIO | Active comparator | Other: NOTES, Other: AUDIOPatients in this arm will receive both the NOTES and AUDIO intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 65 years;
- With multimorbidity (diabetes or hypertension plus one of the following: arthritis (osteoarthritis and rheumatoid arthritis), asthma, atrial fibrillation, Alzheimer's disease and related dementia (not severe), cancer, chronic obstructive pulmonary disease, depression, heart disease, heart failure, hyperlipidemia, osteoporosis, kidney disease and stroke. Patients with diabetes plus hypertension are eligible.
- Have had two or more clinic visits in the previous 12 months;
- Plan on receiving ongoing care at the clinic with the enrolled clinician for the subsequent 6 months;
- Do not have vision or hearing problems that cannot be corrected; and
Key exclusion criteria (13 listed)
- With no capacity to consent to the project;
- With schizophrenia and other psychotic disorders, current substance-use disorders, uncorrected hearing or visual impairment with no adjustments to support accessing the interventions or surveys;
- Living in skilled nursing homes or hospice, because they engage less in self-management;
- With cognitive impairment as identified by a score of ≤4 on the six-item screener (SIS)
- Lacking internet access;
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 |
|---|---|---|
| NOTESThe intervention will include: (1) a brief training on using the patient portal to access written visit information with assistance in setting up patient portal accounts where necessary (including strategies to share notes with a caregiver), (2) post-visit reminders to use the patient portal to access written visit information. | Other | NOTES, NOTES + AUDIO |
| AUDIOThe intervention will include: (1) audio recording all visits with the study clinician for six months, (2) training on how to record visits and access visit recordings, and (3) post-visit reminders listen to the visit recordings. | Other | NOTES + AUDIO |
Primary outcome
Quality of Life - Mental functioning
Time frame: 6 months from enrollment
Quality of life using Global PROMIS (Patient-Reported Outcome Measurement Information System) is a 10-item patient reported measure with two domains: mental and physical health. Domain scores range from 4 to 20, with higher scores representing better health.
Quality of Life - Physical functioning
Time frame: 6 months from enrollment
Quality of life using Global PROMIS (Patient-Reported Outcome Measurement Information System) is a 10-item patient reported measure with two domains: mental and physical health. Domain scores range from 4 to 20, with higher scores representing better health.
4 secondary outcomes
Self-management ability
Time frame: 6 months from enrollment
Medication adherence
Time frame: 6 months from enrollment
General satisfaction
Time frame: 6 months from enrollment
Visit communication style and shared decision-making
Time frame: 6 months from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Information about the CHRONICLE TrialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Upon completion of this research, the research data from this project will be deposited with the Patient-Centered Outcomes Data Repository (PCODR), based at the Inter-university Consortium for Political and Social Research (ICPSR), University of Michigan to ensure that the research community has long-term access to the data. This will include all deidentified data from surveys and/or transcripts from recorded interviews or encounters. For those who consent, we will also put identifiable recordings into the repository.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Paul J Barr, PhD principal investigator
Dartmouth College
Kerri L Cavanaugh, MD principal investigator
Vanderbilit University Medical Center
Meredith C Masel, PhD principal investigator
University Texas Medical Branch
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOTES and AUDIO in people with Diabetes Mellitus and Hypertension, run by Dartmouth-Hitchcock Medical Center at 3 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 10 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul J Barr, PhD (603-646-7016, paul.j.barr@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life - Mental functioning (time frame: 6 months from enrollment). The study lists 2 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 18 May 2026.