Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00413933
Other study ID # sor444506ctil
Secondary ID
Status Terminated
Phase N/A
First received December 19, 2006
Last updated April 20, 2016
Start date April 2008
Est. completion date June 2011

Study information

Verified date December 2006
Source Soroka University Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the comprehensive multidisciplinary intervention (geriatrician, physical therapist and occupational therapist falls risk assessment and intervention)is effective in the falls prevention in the community dwelling elderly.


Description:

Falls and related injuries among elderly people are a major public health problem worldwide.All older people with recurrent falls or assessed as being at increased risk of falling should be considered for an individualized multifactorial intervention.

In successful multifactorial intervention programmes the following specific components are common - against a background of the general diagnosis and management of causes and recognized risk factors:

- exercise

- home hazard assessment and intervention

- vision assessment and referral

- medications list review with modification/withdrawal We will address to 4000 randomly chosen patients from study population (elderly (65+) men and women, living in Beer-Sheva and Ofakim , Israel and belonging to Clalit HMO). This telephone interview will be conducted to reveal falls in last 12 months. The people who do fall (1 + falls) will be invited to research assistant.

In that meeting the research assistant will explain about the study aims and ask them to sign informed consent. Those who do not agree to participate - will be referred to their family doctor for further assessment.

Those who agree to participate in the study will fill in questionnaire about falls (causes, circumstance, results). All will pass through: cognitive assessment by the Mini-Mental State Examination (MMSE), affective assessment by the 15-item Geriatric Depression Scale (GDS), functional assessment by Barthel Index (BI), visual assessment by Snellen charts and basic gait assessment by a "Timed get Up and Go" test (TU&G).

Participants that fulfill inclusion criteria will be randomly assigned to the intervention group or the control group. All participants will be instructed to call to the research assistant closely to each fall.

All information about assessment of patients in both groups will be transferred to the family physician. Their family physician according to his opinion will treat patients from usual care group.

A geriatrician, physiotherapist and occupational therapist will observe patients in the intervention group. OT will conduct a home visit to assess hazard and level of risk factor for falling. Results of assessment will be discussed on multi- disciplinary team meeting.

According to this plan each patient in this group will receive one or more following interventions:

1. Written recommendation to the family physician for medication adjustment. As well, the geriatrician will discuss with family physician these recommendations.

2. Recommendation to the family physician to refer the patient to optometrist/ ophthalmologist.

3. Physical therapy: each subject in intervention group will get 15 weekly sessions (each session - 45 minutes) of specified exercise from a physical therapist that specializes in fall prevention and walking device recommendations. All subjects will get brochure for home exercise. It will be expected for intervention group to exercise twice daily, each time for 20 minutes in addition to the PT sessions.

4. Occupational therapy: OT will make recommendation for changing any unsafe environments in the home.

First follow-up (four months after baseline assessment):

1. OT will make a second home visit to each subject of the intervention group to check recommendation fulfillment.

2. Study assistant will repeat baseline assessment (MMSE, GDS, BI, TU&G and visual assessment by Snellen chart).

3. Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.

4. Information about medication adjustment and changes will be collected from Clalit computerized system.

Second follow-up (12 months after baseline assessment ) :

1. Study assistant will repeat baseline assessment (MMSE, GDS, BI, TUG test and visual assessment by Snellen chart).

2. Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.

3. Information about medication adjustment and changes will be collected from Clalit computerized system.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Living in Beer Sheva or Ofakim , Israel

- Members of Clalit HMO

- 1 or more falls in past 12 month (self-reported)

- Age 65 or more

- Mobile outdoors without wheelchair

Exclusion Criteria:

- Seriously ill patients - as dyspnea with light exercise, unstable heart disease

- MMSE less than 18

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
Comprehensive Multidisciplinary Intervention
Comprehensive Multidisciplinary Intervention

Locations

Country Name City State
Israel Department of Family Medicine, Faculty of Health Sciences, Ben Gurion University of the Negev Beer- Sheva

Sponsors (1)

Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of falls 4 and 12 monthes No
See also
  Status Clinical Trial Phase
Recruiting NCT05880862 - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls Early Phase 1
Completed NCT03963570 - The Effectiveness of a Self-managed Digital Exercise Programme to Prevent Falls in Older Community-dwelling People N/A
Recruiting NCT04053829 - Feasibility and Acceptability of HOLOBalance Compared to Standard Care in Older Adults at Risk for Falls N/A
Not yet recruiting NCT04419753 - The Role of Attention Focus Walking Training in Older Adults. N/A
Completed NCT02836587 - The Influence of Balance Training on Postural Control in Elderly N/A
Completed NCT02916849 - A Feasibility Study of a Mobile Application Intervention to Promote Strength and Balance Exercises in Older People N/A
Active, not recruiting NCT02617303 - Prevention of Falls and Its Consequences in Elderly People N/A
Completed NCT01896466 - Enhanced Gait and Balance Training N/A
Completed NCT02570178 - Effectiveness of an Intervention to Improve Balance and Decrease Falls in the Elderly (EWii) N/A
Completed NCT00636675 - CONNECT for Quality: A Study to Reduce Falls in Nursing Homes N/A
Completed NCT00365430 - SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes N/A
Completed NCT00226486 - Examination and Treatment of Elderly After a Fall N/A
Active, not recruiting NCT00222287 - The Effect of Feldenkrais Lessons on Walking and Balance Phase 1
Recruiting NCT03731572 - Hip Muscle Power, Lateral Balance Function, and Falls in Aging N/A
Recruiting NCT05625828 - Evaluation of the Effects of a Cognitive-Motor Fall Prevention Program on Fall Risk Factors N/A
Recruiting NCT05377801 - Chinese Version of LIVE-LiFE for Older Adults With Previous Falls N/A
Completed NCT01618786 - Flooring for Injury Prevention Trial N/A
Completed NCT02835989 - Community Paramedicine at Home N/A
Recruiting NCT02926105 - Comparison of Home-based Exercise Programmes for Falls Prevention and Quality of Life in Older Adults Phase 3
Completed NCT02569138 - Balance-Enhancing Effects of Insole Hardness and Thickness for Older Adult Footwear N/A