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临床试验/NCT05824572
NCT05824572进行中(未招募)不适用

The Effect of Clinic Visit Audio Recordings for Self-management in Older Adults

Dartmouth-Hitchcock Medical Center4 个研究点 分布在 1 个国家目标入组 336 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
336
试验地点
4
主要终点
Patient Activation Measure-Short Form

研究概览

简要总结

The objective of this study is to conduct a multisite trial evaluating the impact of adding an audio recording of clinic visits (AUDIO) to usual care in older adults with multimorbidity, including diabetes, compared to After Visit Summary (AVS) alone (Usual Care; UC).

详细描述

The objective of this study is to conduct a multisite trial evaluating the impact of adding an audio recording of clinic visits (AUDIO) to usual care in older adults with multimorbidity, including diabetes, compared to AVS alone (Usual Care; UC). The specific aims are: Aim 1 Conduct a three-site trial in primary care where older patients with multimorbidity including diabetes (n=336) will be randomized to receive an audio recording as well as AVS (AUDIO) versus AVS alone (UC) for all scheduled clinic visits over 12 months; patients will be assessed at baseline, 1 week, 6 months and 12 months. Applicants hypothesize (Main Effect) that: compared to those receiving UC, patients randomized to also receive audio recordings (AUDIO) of clinic visits will report a greater self-management ability (Primary Outcome), with improved quality of life, medication adherence, and satisfaction (Secondary Outcomes) at 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients participants:
  • •Inclusion Criteria:
  • •Patients who are ≥ 65 years;
  • •Patients with multimorbidity (i.e. patient has diabetes and one or more chronic conditions including: arthritis, asthma, atrial fibrillation, cancer, chronic obstructive pulmonary disease, heart disease, depression, heart failure, hypertension, osteoporosis, kidney disease and stroke);
  • •Have had two or more clinic visits in the previous 12 months;
  • •Plan on receiving ongoing care at the clinic for the subsequent 12 months;
  • •Do not have any vision or hearing problems that cannot be corrected;
  • •Have not recorded a clinic visit for personal use i the past 6 months.

排除标准

  • •Without capacity to consent to the project;
  • •With schizophrenia and other psychotic disorders, substance-use disorders, uncorrectable hearing or visual impairment or a six item screener (SIS) cognitive function score ≤ 4;
  • •Living in skilled nursing homes or hospice;
  • •Patients who have audio- recorded a clinic visit for their personal use in the previous six months;
  • •Patients who do not speak English or Spanish;
  • •Patients who lack internet access;
  • •Patients who (a) do not have access to a personal email, (b) do not have an email address shared with a family member or patient-identified caregiver, and (c) are not interested in creating an email account between the time they are first contacted by the study team to the time that the study team requires an email address to initiate the online recording software registration.
  • •Clinician participants:
  • •Inclusion criteria:
  • •Licensed clinician (MD including clinician residents at Dartmouth Health locations, DO, APRN, NP, PA)
  • •Are based at the study clinic;
  • •Who treat adult patients.
  • •Exclusion criteria:
  • •Are trainees, e.g., fellows, medical students or residents, with the exception of clinician residents at Dartmouth Health;
  • •Commonly audio or video record clinic visits for patient's personal use.

研究组 & 干预措施

Audio

Active Comparator

Researchers will audio record both in-person and telehealth visits of participants in the intervention group.

干预措施: Clinic visit audio recordings for self-management in older adults (Other)

Usual care

Placebo Comparator

Participants will receive Usual Care

干预措施: Usual Care (Other)

结局指标

主要结局

Patient Activation Measure-Short Form

时间窗: Patient activation at 12-months from enrollment

The Patient Activation Measure-Short Form is a 13-item patient reported measure. Scores range from 0 (low activation) to 100 (high activation).

次要结局

  • Global PROMIS 10(Global PROMIS 10 at 12 month from enrollment)
  • Adherence to Refills and Medications-D (ARMS-D)(Adherence at 12-months from enrollment)
  • Patient Satisfaction Questionnaire-18(Patient satisfaction at 12-months from enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul J. Barr

Associate Professor

Trustees of Dartmouth College

研究点 (4)

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