Disability of Musculoskeletal Origin in Community-dwelling Elderly: Efficacy of a Specific Clinical Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Number of subsequent DIMS
研究概览
简要总结
Objectives: To assess the efficacy of an intervention program targeted to the elderly with recent-onset disability of musculoskeletal origin (DIMS), and to perform its economic evaluation.
详细描述
Methodology: 1) Controlled randomised intervention study (3 years). Subjects: persons older than 65 in health district 7 of Madrid with acute (< 3 months) DIMS. Intervention group patients will be attended by rheumatologists acording with clinical (diagnostic and therapeutical) protocols. Control group will receive the routine attention from the Health System. Efficacy and costs variables will be collected through monthly structured telephone interviews performed by independent personnel blinded to the intervention group. Efficacy will be measured by differences between groups regarding: 1) time to improvement in the baseline DIMS episode, 2) number of subsequent DIMS, and 3) total number of DIMS days. An economic evaluation will be performed from a societal perspective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, 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
- •Diagnosis of Musculoskeletal disorder
- •Older than 64 years
- •To have disability measured with a) or b):
- •Rosser clasification: at least
- •M.Gill questionnaire: To need help from other person to dress, to tidy up itself, to walk or to stand up.
- •Disability of recent onset:less than three months.(Patiens had a better functional situation before)
排除标准
- •Recent surgery
- •Dementia with no family support
- •Institutionalized
研究组 & 干预措施
Care in the Control Group (CG)
Care in the Control Group (CG): was that provided by the General Practitioners, with basic diagnostic and therapeutic procedures without specified protocols.
Early Intervention Programa (IG)
Early Intervention Programa (IG): Patients assigned to the intervention group after the randomization were offered an immediate appointment. Patients, who voluntarily accepted, were attended by 2 rheumatologists. The rheumatologists acted as principal care providers in regular visits, home visits and phone contacts. The visits were structured following specific proceedings for the different diagnoses based on previously demonstrated approaches. Such protocols included education and promotion of independence, pharmacological and no pharmacological treatment, and timing of diagnostic tests in a stepwise manner. The program also incorporated administrative duties such as the prescription of medication for the patients. Patients were seen as often as necessary according to the medical rheumatologist decision (until the episode of disability was medically resolved).
干预措施: Specific clinical care program (Procedure)
结局指标
主要结局
Number of subsequent DIMS
时间窗: Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level
Time to improvement in the baseline recent-onset disability episode of musculoskeletal origin (DIMS)
时间窗: Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level
Total number of DIMS days
时间窗: Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level
次要结局
- Direct and Indirect Costs(Period of time in days until the patients recovers defined as: an improvement in at least one point in the Rosser disability level)