A Pilot Study of an eHealth-delivered Health Coaching Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Completion Rate: Number of Participants Completing the Intervention
研究概览
简要总结
The national epidemic of obesity is associated with considerable morbidity, disability and early mortality.
Conventional weight loss programs beyond a primary care setting have the potential to reduce weight, but are difficult to access for adults with obesity in rural areas due to lack of transportation and access to specialty care. Routine intensive behavioral therapy, while effective, is often not supplemented with adjuncts that could be helpful in engaging participants in behavioral change. The overarching goal of this SYNERGY pilot project is to overcome barriers rural adults face by using video-conferencing to deliver specialty obesity care that otherwise is inaccessible to most adults faced with this disease. It also intends to use emerging mobile health (mHealth) technology which has shown considerable promise in providing motivational feedback. This proposal highlights T3/T4 translation bridging technologists, allied health staff, and clinicians in the development and implementation of new therapeutic modalities. The study aims to evaluate a telehealth-based health coaching program that is embedded in the Dartmouth-Hitchcock Weight and Wellness Center that integrates novel remote monitoring technology in effecting behavioral change using Amulet, a Dartmouth Computer Science developed mHealth device over a 16-week period. First, the feasibility and accessibility of an eHealth-delivered health coaching obesity intervention using remote monitoring and video-conferencing (Aim 1) will be evaluated. The potential effectiveness of achieving the primary outcome of 5% weight loss, with secondary outcomes of improved physical function and self reported health (Aim 2) will be ascertained. The intervention's impact on implementation outcomes of workflow, adoption, and organizational change that could affect further scalability and generalizability in other high-risk population groups (Aim 3) will be assessed. These preliminary findings will be used in a future competitive application for an extramural R01 designed to assess the effectiveness of our intervention in achieving weight loss in rural obese adults. If successful, this application has the potential to redesign care using applied methods of telehealth translated to community-based, rural populations to facilitate behavioral change. The project also meets criteria of the NIH Strategic Plan for Obesity and the Institute of Medicine's need for Telehealth research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking;
- •Community-dwelling;
- •Age 18-65 years;
- •Obesity based on: BMI ≥30kg/m2 54;
- •Participating in the DH-WWC health coach program;
- •Access to home, high-speed internet with Wi-Fi;
- •Medical clearance from their primary care provider;
- •Provide voluntary, written consent;
- •Require an EHR patient portal account and credentials ; -----If subjects do not have an account, one will be created for the purposes of this study
排除标准
- •Unwilling to participate in the 16 week pilot or complete study measures;
- •Individuals unwilling/unable to provide consent;
- •A medical record diagnosis of dementia as intensive behavioral therapy and health coaching require the ability to complete questionnaires and change behavior, all of which may be challenging in individuals with cognitive impairment;
- •Cognitive impairment measured by the 6-item Callahan screen, a brief and reliable six-item screening questionnaire with acceptable sensitivity (88.7%) and specificity (88.0%) in identifying individuals with cognitive impairment. Its diagnostic properties are comparable to the full Folstein Mini-Mental Status Examination in those scoring ≥
- •This questionnaire can be administered by telephone or face-to-face interview and is being as an adjunct to medical record documentation of cognitive impairment;
- •Life-threatening illness including those receiving palliative care or hospice services;
- •Nursing facility or hospital admission in the past six months;
- •Psychiatric diagnosis that would interfere with study participation and require significant modification to meet their needs such as major depressive disorder, substance abuse, suicidal ideation or severe mental illness (schizophrenia, bipolar disorder);
- •History of bariatric surgery;
- •American College of Sports Medicine contraindications to exercise57 including: a resting heart rate of >120bpm; Blood pressure >180/100mmHg; unstable angina;
结局指标
主要结局
Completion Rate: Number of Participants Completing the Intervention
时间窗: 16 weeks
Completion/ Feasibility: The following rates will be computed: screened for inclusion; eligibility; enrollment; completion; assessment. We will assess entry criteria (reasons for dropout/non-adherence) and time to collect data. Enrollment success will be defined as 30 patients. Adequate retention is defined as a dropout rate of \<20%. Completion of \>80% of post-study measures will be defined as adequate. Attending \>80% of sessions will be considered acceptable. Staff will track equipment, software or technical issues (malfunctions, data loss, hardware) in a journal.
Acceptability
时间窗: 16 Weeks
Acceptability: Qualitative interviews will ensure the appropriateness of the pilot and its strengths/weaknesses. Participants will answer questions on a scale from 0-5, where 5 = high acceptability of the program.
次要结局
- Subjective Health(Baseline/16 weeks - Change)
- Change in Weight(Baseline/16 weeks)
- Change in 6 Minute Walk(Baseline/16 weeks - pre/post change - increase = longer distance)
- Willingness to Pay(16 weeks)
- Diet Change(Baseline/16 weeks)
- Readiness to Change(16 weeks)
研究者
John A. Batsis, MD
Associate Professor of Medicine and The Dartmouth Institute for Health Policy & Clinical Practice
Dartmouth-Hitchcock Medical Center