中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600116932
最近更新日期： Date of Last Refreshed on：	2026-01-16 15:48:15
注册时间： Date of Registration：	2026-01-16 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	长期照护机构老年人孤独感的远程家庭互动方案的构建及可行性研究
Public title：	Development and Feasibility Study of a Remote Family-Interaction Program to Address Loneliness among Older Adults in Long-Term Care Facilities
注册题目简写：
English Acronym：
研究课题的正式科学名称：	长期照护老年人孤独感的生成机制与干预策略实证研究
Scientific title：	Empirical Research on the Generation Mechanism and Intervention Strategies of Loneliness in Long-Term Care Elderly
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	李诗怡	研究负责人：	郑智慧
Applicant：	Shiyi Li	Study leader：	Zhihui Zheng
申请注册联系人电话： Applicant telephone：	+86 157 1591 2257	研究负责人电话： Study leader's telephone：	+86 139 5028 2581
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	1131260253@qq.com	研究负责人电子邮件： Study leader's E-mail：	2005052@fjtcm.edu.cn
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	福建省福州市闽侯上街邱阳路1号	研究负责人通讯地址：	福建省福州市闽侯上街邱阳路1号
Applicant address：	No. 1, Qiuyang Road, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, China	Study leader's address：	No. 1, Qiuyang Road, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, China
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	福建中医药大学护理学院
Applicant's institution：	School of Nursing, Fujian University of Traditional Chinese Medicine
研究负责人所在单位：	福建中医药大学附属第三人民医院
Affiliation of the Leader：	The Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2025KS-148-1	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	福建中医药大学附属第三人民医院伦理委员会
Name of the ethic committee：	Ethics Committee of the Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine
伦理委员会批准日期： Date of approved by ethic committee：	2025-12-11 00:00:00
伦理委员会联系人：	陈天懿
Contact Name of the ethic committee：	Tianyi Chen
伦理委员会联系地址：	福建福州市闽侯县上街镇国宾大道363号
Contact Address of the ethic committee：	No.363 Guobin Avenue, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 591 6208 0211	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

福建中医药大学附属第三人民医院

Primary sponsor：

The Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

福建福州市闽侯县上街镇国宾大道363号

Primary sponsor's address：

No.363 Guobin Avenue, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	福建	市(区县)：	福州
Country：	China	Province：	Fujian	City：	Fuzhou
单位(医院)：	福建中医药大学护理学院	具体地址：	福建省福州市闽侯上街邱阳路1号
Institution hospital：	School of Nursing, Fujian University of Traditional Chinese Medicine	Address：	No. 1, Qiuyang Road, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, China

经费或物资来源：

暂无

Source(s) of funding：

None

研究疾病：

老年人孤独感

Target disease：

Loneliness in the elderly

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

本研究旨在针对长期照护机构老年人普遍存在的孤独感问题，构建一套远程家庭互动的干预方案，并进行可行性研究。一方面，通过系统化方案的设计与实施，探索如何借助信息化手段增强老年人与家庭成员之间的情感联结，改善其社会支持感受，从而缓解孤独感；同时，验证该方案在长期照护环境中的可行性并探索有效性，为后续护理干预策略的推广应用提供参考。

Objectives of Study：

This study aims to address the widespread loneliness among elderly people in long-term care facilities by developing a remote family interaction intervention program and conducting a feasibility study. On one hand, through the systematic design and implementation of the program, it explores how information technology can be used to enhance the emotional connection between the elderly and their family members, improve their sense of social support, and thus alleviate loneliness. On the other hand, it verifies the feasibility and effectiveness of this program in long-term care settings, providing a reference for the promotion and application of subsequent nursing intervention strategies.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

(A) Elderly Residents: Must meet all of the following criteria:
1. Age >= 65 years, residency duration >= 1 month;
2. Possess basic communication skills;
3. Be informed, participate voluntarily, and sign a written informed consent form;
4. Loneliness level reaches the cutoff point: ULS-6 >= 12 points;
5. At least one family member is willing to participate in weekly remote interaction according to the intervention plan (participation can be rotated).
(B) Family Members: Must meet one of the following criteria:
1. Have a direct family relationship or primary care decision-making relationship with the elderly person;
2. Have the ability to use smart devices and communicate online;
(C) Institutional Management Personnel: Note: Institutional management personnel are not included in the effectiveness measurement; they are only used for research organization and coordination, and intervention implementation.
1. Heads of nursing departments/care team leaders/social workers, etc., directly related to the research subjects;
2. Understand the institution's care management processes and information technology usage;
3. Sign consent and are willing to cooperate with the research implementation (e.g., assisting with recruitment, technical support, and quality control).

排除标准：

1.合并严重精神障碍或急性疾病； 2.无法配合远程互动者； 3.家庭成员拒绝参与； 4.当前急性重症、濒危或预计1月内难以完成随访。

Exclusion criteria：

1. Comorbid severe mental disorder or acute illness; 2. Unable to cooperate with remote interaction; 3. Family members refuse to participate; 4. Currently acute and severe, critically ill or expected to be unable to complete follow-up within 1 month.

研究实施时间：

Study execute time：

从 From 2026-04-01 00:00:00至 To 2026-10-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-04-01 00:00:00 至 To 2026-06-01 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	30
Group：	Control Group	Sample size：	30
干预措施：	对照组在机构现行照护基础上，接受标准化老年护理服务和以孤独感为重点的常规护理。	干预措施代码：
Intervention：	The control group received standardized elderly care services and routine care focusing on loneliness, in addition to the existing care provided by the institution.	Intervention code：

组别：	干预组	样本量：	30
Group：	Intervention Group	Sample size：	30
干预措施：	在常规照护基础上，实施远程家庭互动干预。	干预措施代码：
Intervention：	In addition to routine care, implement remote family interaction interventions.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	福建	市(区县)：	福州
Country：	China	Province：	Fujian	City：	Fuzhou
单位(医院)：	福建中医药大学附属第三人民医院	单位级别：	三级
Institution hospital：	The Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	依从率	指标类型：	主要指标
Outcome：	Compliance rate	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	孤独感	指标类型：	主要指标
Outcome：	Loneliness	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	感知社会支持	指标类型：	次要指标
Outcome：	Perceived Social Support	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	家庭互动质量	指标类型：	次要指标
Outcome：	Family interaction quality	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	生活质量	指标类型：	次要指标
Outcome：	Quality of life	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	None	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age		岁 years
最大 Max age		岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由研究者生成序列（Excel 随机数字表法）：由未参与招募与评估的研究助理在 Excel 创建受试者编号清单；在相邻列为每个编号生成随机数 =RAND()；按随机数从小到大排序，按顺序交替标注“干预/对照”（或用 0/1）；导出成随机分配表（加日期与版本号）。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The sequence is generated by the researcher (using an Excel random number table): A research assistant who was not involved in recruitment and evaluation creates a list of participant numbers in Excel; Generate a random number for each number in an adjacent column using the formula =RAND(); Sort the random numbers in ascending order and alternately label them as "Intervention/Control" (or 0/1); Export the result as a random assignment table (with date and version number).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

由于干预性质明显，参与者与执行者不盲；为减少偏倚，评估过程由未参与干预的研究者独立完成。数据录入与清洗阶段采用编号管理，不包含分组变量，以避免录入者主观偏倚。数据核查完毕后，研究团队将分组表与主数据表通过编号合并，进入统计分析阶段。基线评估在揭盲前完成；全程保留随机与启封日志（编号、时间、操作者、结果）；两组常规照护一致。

Blinding：

Because the intervention was clearly defined, participants and implementers were not blinded; to reduce bias, the assessment process was completed independently by researchers who did not participate in the intervention. Data entry and cleaning were managed using numbering systems and did not include grouping variables to avoid subjective bias from the data entry personnel. After data verification, the research team merged the grouping table and the master data table using numbering before proceeding to the statistical analysis stage. Baseline assessment was completed before unblinding; randomization and unblinding logs (number, time, operator, result) were maintained throughout the process; both groups received consistent routine care.

是否共享原始数据： IPD sharing	否No
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	NA
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	纸质结合电子采集和管理
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Paper-based combined with electronic data collection and management
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2026-01-16 15:47:58