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Behavioural Intervention

Visit Summaries + Audio Recordings for Chronic Disease Care (CHRONICLE Trial)

N/A
Recruiting
Led By Paul J Barr, PhD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must plan on receiving ongoing care at the clinic with the enrolled clinician for the subsequent 6 months
Patients must not have recorded a clinic visit for personal use in the past 6 months
Must not have
Caregivers with no capacity to consent to the project
Patients who do not speak English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months from enrollment
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare how giving written info & audio recordings of visits to seniors with chronic diseases affects quality of life & other outcomes. Caregivers can also join.

Who is the study for?
This trial is for older adults (65+) with chronic diseases like high blood pressure or diabetes, plus another condition. They must have used the clinic twice in the last year and plan to continue there. Caregivers can join if they're over 18 and speak English or Spanish. Excluded are those with severe mental health issues, no internet/email access, or who live in nursing homes/hospice.
What is being tested?
The CHRONICLE study compares two methods: providing patients written summaries of their visits via a portal (NOTES) versus adding audio recordings of the visits (AUDIO). It aims to see which method better improves quality of life for older adults managing chronic illnesses.
What are the potential side effects?
Since this trial involves non-medical interventions such as NOTES and AUDIO recordings, traditional side effects associated with medications are not applicable here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I plan to continue my care at the clinic with my current doctor for the next 6 months.
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I haven't recorded a clinic visit for my own use in the last 6 months.
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I am 65 years old or older.
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My vision and hearing are correctable.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a caregiver unable to give consent for the project.
Select...
I do not speak English or Spanish.
Select...
I am unable to give consent for medical procedures or trials.
Select...
I am a caregiver who does not speak English or Spanish.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months from enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months from enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quality of Life - Mental functioning
Quality of Life - Physical functioning
Secondary study objectives
General satisfaction
Medication adherence
Self-management ability
+1 more
Other study objectives
Caregiver burden [Caregiver outcome]
Caregiver engagement in clinic visit [Caregiver outcome]
Caregiver preparedness [Caregiver outcome]

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: NOTESActive Control1 Intervention
Patients in this arm will receive only the NOTES intervention.
Group II: NOTES + AUDIOActive Control2 Interventions
Patients in this arm will receive both the NOTES and AUDIO intervention.

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
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The University of Texas Medical Branch, GalvestonOTHER
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Vanderbilt University Medical CenterOTHER
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Beth Israel Deaconess Medical CenterOTHER
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Patient-Centered Outcomes Research InstituteOTHER
580 Previous Clinical Trials
27,104,059 Total Patients Enrolled
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2,664,576 Patients Enrolled for Diabetes
Paul J Barr, PhDPrincipal InvestigatorDartmouth College
4 Previous Clinical Trials
551 Total Patients Enrolled
1 Trials studying Diabetes
336 Patients Enrolled for Diabetes
Kerri L Cavanaugh, MDPrincipal InvestigatorVanderbilit University Medical Center
2 Previous Clinical Trials
427 Total Patients Enrolled
1 Trials studying Diabetes
336 Patients Enrolled for Diabetes
Meredith C Masel, PhDPrincipal InvestigatorUniversity Texas Medical Branch
2 Previous Clinical Trials
427 Total Patients Enrolled
1 Trials studying Diabetes
336 Patients Enrolled for Diabetes

Media Library

AUDIO (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05955339 — N/A
Diabetes Research Study Groups: NOTES, NOTES + AUDIO
Diabetes Clinical Trial 2023: AUDIO Highlights & Side Effects. Trial Name: NCT05955339 — N/A
AUDIO (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05955339 — N/A
~800 spots leftby Apr 2027
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