Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 638
- 试验地点
- 2
- 主要终点
- Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects
研究概览
简要总结
This study evaluates a mobile phone-delivered intervention (FAMS 2.0; Family/friend Activation to Motivate Self-care) designed to help adults with type 2 diabetes set and achieve self-care goals and improve the quality of family/friend support for their goals. The investigators hypothesize that FAMS 2.0 will improve glycemic control and reduce diabetes distress among patients and reduce support burden and diabetes distress in enrolled support persons. The investigators hypothesize the mechanisms by which FAMS 2.0 will affect these outcomes for the patient include (a) increased helpful and reduced harmful family/friend involvement, (b) increased self-care (i.e., diet, physical activity, medication adherence), and (c) increased diabetes self-efficacy.
详细描述
The 9-month FAMS 2.0 intervention is an expansion and improvement of a previously evaluated intervention (FAMS; NCT02481596). FAMS components include:
- Monthly coaching sessions (20-30 minutes each) with patient participants by phone focusing on helpful/unhelpful/desired family and friend behaviors relevant to the patients' self-identified diet, exercise, and/or stress management goal
- Daily one-way and interactive text messages to the patient to support him/her in meeting the identified daily goal and medication adherence
- Weekly interactive text messages asking the patient to reflect on goal progress followed by personalized feedback from the coach
- The option to invite an adult support person to receive text messages (3 one-way per week and one interactive text per week) encouraging the support person to discuss the patient's self-care goal to provide opportunities for the patient to practice skills discussed during phone coaching
Participants will be randomized in a parallel design to either FAMS 2.0 or an active control. Our target enrollment is N=334 dyads (patient participants and support persons). Patients are encouraged to invite a support person, but it is not required. Patients and their support person will be randomized together (if enrolled). The study is powered to detect a 0.5% reduction in hemoglobin A1c. Analyses will examine effects at 9 months (post-intervention) and 15 months (sustained effects). The investigators will impute missing data, including all participants completing at least two data collection periods in analyses. Participants will be analyzed as randomized regardless of withdrawal from the intervention (i.e., intention-to-treat principals).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigators use mail-in A1c kits for the primary outcome - hemoglobin A1c - and the lab analyzing these samples is masked to study description or participants' assigned condition.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Speaks and reads in English
- •18-75 years old
- •Diagnosed with type 2 diabetes
- •Receiving outpatient care from a partnering clinic
- •Community dwelling (e.g., not in a nursing facility)
- •Prescribed at least one daily diabetes medication
- •Owns a mobile phone
- •SUPPORT PERSONS:
- •Speaks and reads in English
- •18 years or older
- •Owns a mobile phone
排除标准
- •Unable to communicate by phone
- •Pregnant currently
- •Currently undergoing treatment for cancer (e.g., radiation, chemotherapy)
- •Diagnosed with end-stage renal disease
- •Receiving hospice services
- •Diagnosed with congestive heart failure
- •Diagnosed with dementia
- •Diagnosed with schizophrenia
- •Reported current abuse during screening
- •Demonstrates inability to receive and respond to a text
- •Does not take medication on his/her own/medication administered by someone else
- •SUPPORT PERSONS:
- •Demonstrates inability to receive and respond to a text
结局指标
主要结局
Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects
时间窗: Baseline and 12 and 15 months post-baseline
Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control
Change in Diabetes Distress (Patient Participants) During Intervention Period
时间窗: Baseline and 6 and 9 months post-baseline
Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)
Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect
时间窗: Baseline and 15 months post-baseline
Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)
Change in Glycemic Control (Patient Participants) During Intervention Period
时间窗: Baseline and 6 and 9 months post-baseline
Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control
Change in Psychosocial Well-being (Patient Participants) During Intervention Period
时间窗: Baseline and 6 and 9 months post-baseline
Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better)
Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect
时间窗: Baseline and15 months post-baseline
Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better)
次要结局
- Change in Diabetes Distress (Support Person Participants) During Intervention Period(Baseline and 6 and 9 months post-baseline)
- Change in Support Burden (Support Person Participants) During Intervention Period(Baseline and 6 and 9 months post-baseline)
- Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect(Baseline and 15 months post-baseline)
- Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect(Baseline and 15 months post-baseline)
研究者
Lindsay Mayberry
Principal Investigator
Vanderbilt University Medical Center