A Nurse-led Coaching Programme With Telemonitoring in Heart Failure: Protocol for a Randomized Controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
The goal of this pilot interventional study is to assess the feasibility and acceptability of a supportive intervention for patients affected by heart failure. The main questions it aims to answer are:
- Are implementation strategies effective in facilitating participant fidelity?
- What factors contribute to patients' satisfaction with the designed intervention, and how can these be optimized for improved patient experience and adherence?
- Are the methods and tools established the most appropriate to ensure the completeness of the data collection?
Participants will follow a combined intervention consisting of:
- pre-discharge educational meeting;
- telephone nurse-led coaching sessions;
- home telemonitoring of vital signs.
In the main trial, researchers will compare data from the intervention group with a control group to assess whether it reduces hospitalization rates and improves self-care capabilities
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 assessors will collect clinical outcomes by telephone and will be blinded to the group assignment
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
- •aged 65 and over
- •hospitalized for cardiac decompensation, regardless of ejection fraction (FE) value (preserved or decreased)
- •expected to be discharged home will be considered eligible.
排除标准
- •Individuals who lack the cognitive and/or physical capabilities (Mini-COG +) for self-monitoring of vital signs, and without a caregiver available to assist them
- •people who receive other medical services
研究组 & 干预措施
Controlled group
The controlled group will receive usual care
Nurse-led supported group
A supportive program consisting of the following elements will be provided:
- Pre-discharge educational meeting. After the patient is deemed stable, an in-hospital educational intervention will be provided by a trained nurse not involved in the clinical pathway. Key topics of self-care management recognized by the European Society of Cardiology will be discussed.
- Telephone nurse-led coaching sessions. In this phase, patients will be encouraged to focus on their values and progress towards their goals. The intervention will be customized based on the objectives identified during the initial meeting. The scheduled sessions will occur weekly during the first months and then transition to twice a month thereafter.
- Patients will receive education on measuring weight, blood pressure, heart rate, and oxygen saturation at rest, every morning before breakfast. All participants will be provided with a telemonitoring system that transmits data to a web platform via Bluetooth.
干预措施: Nurse-led telephone coaching intervention with home telemonitoring of vital signs (Combination Product)
结局指标
主要结局
Recruitment rate
时间窗: 6 months
the proportion of patients who agreed to participate relative to those who fulfilled the inclusion criteria.
Adherence to telemonitoring program
时间窗: 4 months.
the proportion of days during which vital signs were measured and sent by the system relative to the total duration of the intervention
Completeness of data collection
时间窗: baseline, after 3 and 6 months
number of returned questionnaires.
Retention rate
时间窗: 6 months
the proportion of patients who complete the study and those who consent to participate
Adherence to the coaching intervention
时间窗: 4 months.
the number of coaching phone calls scheduled and actualized
次要结局
- 90- and 180-day Emergency Departments visits(Data collection is planned at 3 and 6 months.)
- 90- and 180-day heart failure-related hospital readmissions(Data collection is planned at 3 and 6 months.)
- 90- and 180-day oupatient visits(Data collection is planned at 3 and 6 months.)
- 90- and 180-day all-cause hospital readmissions(Data collection is planned at 3 and 6 months.)
- 90- and 180-day General Practioner visits(Data collection is planned at 3 and 6 months.)
- Heart Failure Somatic Perception Scale v.3 (HFSPS)(Data collection is planned at baseline, 3 and 6 months.)
- Mortality(Data collection is planned at 3 and 6 months.)
- Quality of life (SF-12 scale)(Data collection is planned at baseline, 3 and 6 months.)
- Self-care capacity (Self-Care of Heart Failure Index )(Data collection is planned at baseline, 3 and 6 months.)
- Self Care - Self-Efficacy Scale(Data collection is planned at baseline, 3 and 6 months.)
- Anxiety (Hamilton Anxiety Scale )(Data collection is planned at baseline, 3 and 6 months.)
- Depression (Geriatric Depression Scale)(Data collection is planned at baseline, 3 and 6 months.)
研究者
Alberto Dal Molin
Associate Professor
Università degli Studi del Piemonte Orientale Amedeo Avogadro