Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02645006 |
| Other study ID # |
SomamfycCTNF |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2
|
| First received |
December 29, 2015 |
| Last updated |
December 31, 2015 |
| Start date |
May 2015 |
| Est. completion date |
February 2017 |
Study information
| Verified date |
December 2015 |
| Source |
Sociedad Madrileña de Medicina de Familia y Comunitaria |
| Contact |
María Medina-Sampedro, MD |
| Phone |
+34617281028 |
| Email |
mmedsam[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
Spain: Comité Ético de Investigación Clínica |
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to determine whether a primary prevention workshop is effective
decreasing at least 13% the annual incidence of falls in elderly compared to the habitual
counseling.
Before the first fall incident, the elderly aged 65 or more, living in community, are
invited to attend a workshop on fall preventing activities and factor risk detection. This
activity consists on four sessions (one session per week during three weeks and the fourth
session one year later) in which the elderly are expected to detect their own fall risk
factors, encouraged to introduce healthy habits and to increase physical activity in order
to improve strength and balance specifically.
This workshop has been prepared by family physicians following the latest scientific
recommendations, it will be lead by them on the first edition, but it has not been written
in formal language in order to be used by volunteers concerned about aging topics,
independent from the Health Service.
Description:
This study is a Clinical Trial. The methodology is to compare the incidence of falls in two
groups. The intervention group will attend a three session workshop, will learn to recognize
their risk factors for fall, will be encouraged to adopt a healthy diet (vitamin D
consumption), modify home hazards , and increase physical activity (a strength and balance
program at home and a group walking route). After a monthly telephone follow-up they are
invited to attend a recall session, were they realize the change in the strength and balance
tests results.
The control group will attend a single workshop session summarizing the major points of
prevention of falls ( risk factors of fall, healthy diet and vitamin D consumption, home
hazards, physical activity). After a monthly telephone follow-up they are invited to attend
the three session workshop for further prevention.
GOALS
GENERAL Evaluate the effectiveness of an intervention program in the form of health
education workshop to reduce the incidence of falls in independent population aged 65 and
older living in the community.
SPECIFIC:
1. Estimate and compare the effectiveness of the intervention program in a workshop on
health education from a simple intervention with respect to:
• Final results: Principal: number and percentage of falls regular physical exercise
150 minutes a week of aerobic exercise and two times a week strength training.
Improvement of body mass index. Contribution supplement or vitamin D. Improved test
scores Short Physical Performance Battery (SPPB or test Guralnik)
• Intermediate outcomes: Reduction in the number of risks identified in the home.
assistance to physical exercise as a group. Maintenance or support group for physical
exercise. Reduction of fear of falling (Fall Efficacy Scale abbreviate) Improved
quality of life (EuroQol 5) attendees know how to get up after a fall.
2. Select volunteers in the audience who wish to train to develop new editions of the
workshop as teachers, reaching the Community dimension of primary prevention, under the
supervision of the research group.
3. Other:
- Knowledge: Identify the general risk factors for falls. Identify personal risk
factors for falling. Identify the drugs associated with increased risk of falls.
- Attitudes: Guide in avoiding risk factors and circumstantial household falls.
Recognize lifestyle that favor falls. Reinforce the practice of daily physical
activity. Encourage changes towards a balanced diet. Reviewing the reasons for
fear of falling. Support the creation of self-help groups that encourage physical
exercise daily.
- Skills: Apply the advice received in the housing and clothing. Demonstrate that
you know develop a balanced and healthy menu daily. Demonstrate that you know off
the ground after a fall.
METHODOLOGY
Experimental study types randomized clinical trial, controlled, parallel with simultaneous
monitoring of both groups. The scope of the study is the community, the social network to
which they belong major centers of the Community of Madrid Random assignment of senior
centers where the intervention groups of intervention and control is performed.
Masking of participants on receiving the intervention is done, and there is masking the
analysis of statistical data by ignoring what group they belong results. The selection
criteria of the subjects are wide to allow extrapolation of results, increasing the external
validity of the study.
The intervention is a three-session workshop that explores the detection and correction of
risk factors for falls, changing working habits related to falls and applying interventions
that have been shown to be effective in the literature. Working knowledge, attitudes and
skills. It follows a period of one year follow up with monthly phone call to know the
existence of falls in that period and a session assessing memory with changes. The
intervention which is compared with the group counseling reporting the risk factors
associated with falls and the necessary interventions on the habits associated with them.
Working knowledge without delving into the changing attitudes. Follow up with the same
frequency call is performed that intervention to publicize the existence of the group falls
in that period.
In terms of population, the selection will be made according to criteria of inclusion and
exclusion, but recruitment is voluntary type. The workshop will promote the community level
where the senior center selected as the site is located and workshop point to the interested
persons. The inclusion period covering the two weeks prior to the date set for the workshop
until the day before included. demographics (age, sex, cultural and socioeconomic status),
data related to falls (if you have had a fall or previously, current treatment with vitamin
D, concomitant diseases, associates, toxic drugs), accessibility data will be collected
(residence next to the workshop venue, existence of stairs at home, time availability to
attend all sessions, physical limitations to attend regardless).
Person 65 years or older, habitual residence (more than nine months per year) in the
coverage area of the senior center participants, independent ambulation by the field without
help from another person, able to attend: inclusion criteria defined all sessions,
acceptance of telephone follow-up, commitment to attend the final session, and given their
informed consent to participate in the trial.
Institutionalized person, moderate or severe cognitive impairment of any etiology,
blindness, total deafness, trouble reading, absolute contraindication for exercise or
surgery in the previous 6 months: exclusion criteria are defined.
The study variables are the following, in addition to the previously referred to as
demographic, related to falls or Accessibility:
Previous falls yes / no, Alcohol yes / no, grams of alcohol / week Group of neuroleptic
drugs, benzodiazepines, other. Number of drugs. Number of barriers identified as checklist.
Corrected number of barriers. Reduce alcohol consumption, perform the homework, complete
their daily findings, conducted prior to the workshop activity (type of activity, minutes,
times a week), nutritional Journal: points. Weight, height, BMI, waist circumference. Fall
Efficacy Scale abbreviate - points, apply the advice received during the three sessions
(Diet- yes / no, Exercising-yes / no risk Home Improvement yes / no), the group is formed
and go during the three weeks of the workshop but. Make exercise properly off the ground yes
/ no, number of attempts. Vit D treatment prior. Previous physical activity. Stairs at home.
Technical assistance to walk. Limitations to physical activity. Active disease. 5D EuroQol
quality of life: points. Health today points. Existence of hazards in home zones.
The assignment of participants in the control group or the intervention group may not be
random by the type of intervention proposed, but senior centers will be randomized to
receive the workshop with the sequence of intervention or monitoring sequence. It will be
made, by an outside professional to the research team, a random sampling of the list of the
32 Centres for the Elderly in the Community of Madrid. As the intervention meets a priori
criteria of benefit in primary prevention, control group will receive three intervention
sessions of the workshop at the end of the follow-up period of 12 months.
The participant will ignore the existence of the two kinds of workshop, so that masking is
achieved, however, not be possible to sign the informed consent prior to allocation to an
intervention or another. As the researcher who teaches the workshop will be impossible
masking since it will give the workshop in a sequence or another. It can be made in a
double-blind follow-up period to perform the same telephone survey in both groups by a
researcher other than educational workshop. Statistical analysis and evaluation of responses
for statistical development outside the study will be conducted, reaching a triple blind.
As for the follow-up period, it is known that primary prevention to evaluate this time has
to be very long. We have established a period of one year follow-up because it is the
minimum referred to in the literature to detect impact on reducing falls interventions
regarding physical activity and intake of vitamin D. However the aim of the researchers is
to extend monitoring phone in a second phase to complete the second year. Protocol ensures
in a pattern of telephone calls and data collected identical in both groups, scoring the
reason for stopping monitoring whenever possible.
The strategy of data analysis will take into account the exclusion of participants (such as
physical limitations) and causes of abandonment or follow-up workshop. An analysis was done
by intention to treat the participant maintaining the data in the group assigned regardless
of the end of the workshop or not.
The calculated sample size is 316 participants, 158 participants in each arm. Comparison of
two proportions, unilateral test (the intervention is superior to standard treatment), 95%
confidence level, 80% statistical power, P1 (ratio -. Incidence of falls in the gr control
or usual care) 25%, P2 (expected incidence of falls in the intervention group) 12% (13%
reduction). Sample size (n) = 109, expected loss ratio 20%.
Design effect (30 subjects per center. ICC 0.05). Design effect = 1+ (30.01) * 0.05 = about
1.15. Design effect 109 * 1.15 = 126. Adding 20% of losses = 158 participants per arm.
This study is designed as a pragmatic trial, evaluated the effectiveness of the workshop for
primary prevention of falls, with broad selection criteria and heterogeneous population, as
the reality that is to be applied, favoring the generalization of the results.
As for the limitations provided for the study, one of which is the participation of healthy
individuals, and in the prevention field that requires a greater number of participants, a
longer follow-up and possible higher rate of default. Furthermore you risk to specific bias
as participation. You may only select those people who come to senior centers and premises
where cartels are exposed invitation, which will be a priori greatest assets and willing to
activities and social relationships. It is planned around this limitation in later editions
of the workshop, when the offer to other sensitized social partners on this issue expands.
Another limitation is the supply of vitamin D, which has proven effective in those who
present higher deficits of this vitamin. However since it is an external study the health
system will not be available prior analytical determination, or it may decide to supplement
in 600 or 800 units a day but will opt to increase the level of contribution to the diet.
However, to have a letter to the family physician Participant is expected that a percentage
of the participants are evaluated for vitamin deficiencies or receive supplements of vitamin
D. These data will be recorded to be taken into account in the analysis phase.
