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临床试验/NCT00348621
NCT00348621已完成4 期

Clinical Trial of Interventions for Visual Loss in Nursing Home Residents

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 2,544 人开始时间: 1999年6月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
2,544
试验地点
1
主要终点
mobility score

研究概览

简要总结

The purpose of this clinical trial is to determine if interventions within the nursing home to restore vision, or cope with visual loss, in residents with visual impairment result in improvement or less decline in mobility scores, and socialization scores, compared to residents with visual impairment in nursing homes with no such intervention. The investigators hypothesized that nursing home residents with visual loss who receive cataract surgery, or refractive correction, or low vision aids would have have better socialization scores and mobility scores at 6 months and 12 months compared to nursing home residents with visual impairment who are advised to seek services, but have no specific program.

详细描述

The goal of this project was to quantify the impact of visual acuity impairment on socialization and physical function of nursing home residents, and to determine the cost effectiveness of a visual impairment intervention program designed to enhance access to eye care services. To accomplish these aims, the investigators enrolled a complete sample of visually impaired persons from 28 nursing homes in the Lower Eastern Shore of Maryland and Delaware. From the same facilities, the investigators also enrolled a random sample of non-visually impaired residents, with sample size equal to the sample of visually impaired. The group of visually impaired residents was randomized (by facility) to an intervention program or "usual care" group. The intervention program facilitated the utilization of eye care services of the three main causes of visual impairment: refractive error, cataract, and low vision associated with age-related eye diseases. All study groups provided data at baseline, six and twelve months from intervention, and data on eye care utilization, hospitalizations, use of psychoactive medications and mortality collected every other month (bi-monthly). Patients had a screening test of visual acuity, using standard letter/symbol charts, and grating charts. The mental status was tested using the MiniMental State Examination. Social function, physical function, and mobility were assessed through questionnaires asked of nursing home staff familiar with the patient, and the questions were modeled on the Minimum Data Set questions or specially designed for nursing home residents.

The investigators compare the mobility scores, and socialization scores, of nursing home residents with visual loss randomized to the intervention homes to the scores of nursing home residents with visual loss randomized to control homes. The investigators use the mobility and socialization scores of those without visual loss at baseline and follow up to compare with the trajectory of decline in those with visual loss.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • •Nursing homes in Eastern Shore of Maryland,within 1.5 hour drive of Salisbury MD
  • •Nursing home administrators and resident committees approved the study
  • •Nursing home residents:
  • •Age 65 and older
  • •more than 30 day length of Stay
  • •Capable of acuity testing

排除标准

  • •Nursing home residents:
  • •staff assessment noted imminent death likely (within 3 months)
  • •resident unable to provide informed consent and guardian not locatable
  • •resident's only language was not understood by nursing staff

研究组 & 干预措施

Visual impairment intervention program

Active Comparator

enhanced access to eye care services

干预措施: Visual impairment intervention program (Procedure)

Usual care

No Intervention

family and nursing home was apprised of ocular exam results; eye care services left to family/nursing home arrangements

结局指标

主要结局

mobility score

时间窗: 1 year

questionnaire to nurses in charge of nursing home patients on specific items on mobility, which were used to create mobility score

socialization score

时间窗: 1 year

questionnaire to nurses in charge of nursing home patients on items specific to subject socialization, used to create socialization score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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