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Integrative Health Care Model for Climacteric Stage Women
This study is currently Recruiting
May 2011 By Coordinaci?n de Investigaci?n en Salud, Mexico
First Recieved on January 3, 2011
Last Updated on May 18, 2011
Background: Climacteric stage women experience significant biological, psychological and
social changes. With demographic changes being observed in the growing number of climacteric
stage women in Mexico, it is important to improve their knowledge about the climacteric
stage and its potential associated problems, encourage their participation in screening
programs, and promote the acquisition of healthy lifestyles.
At Mexican health care institutions the predominant health care model for climacteric stage
women has a biomedical perspective. Medical doctors provide mostly curative services and
have limited support from other health professionals. This study aims to design an
integrative health care model (IHCM: bio-psycho-social, multidisciplinary and
women-centered) applicable in primary care services aimed at climacteric stage women.
Methods: A field trial with one intervention and one comparison group, with ex ante and ex
post measurements will be conducted in two IMSS primary care clinics in Mexico City. The
clinics will be selected for convenience; each clinic must have more than 20 family doctors'
offices and available space for the intervention (consulting room and an area for group
counseling) and should have accepted to participate in the study; The intervention will be
conducted in one clinic and the other clinic will serve as a comparison group, where the
usual care for climacteric stage women will be observed.
The study population will consist of women affiliated with IMSS, between 45 and 59 years of
age with a maximum of 5 years after menopause. The women should be users of the clinic, and
should not have mental conditions that would prevent them from understanding the information
or from taking independent decisions (dementia, mental retardation or psychosis), a physical
disability that would impede them from participating (hearing loss, diseases affecting
physical mobility as severe forms of rheumatoid arthritis), medical diagnosis of depression,
diabetes mellitus, hypertension, renal or liver failure, and/or cancer, because patients
with these diseases require specific care provided by several specialists. All women must
agree to participate in the study through written informed consent.
The IHCM consists of collaborative and coordinated provision of services by a health team,
which is involves a family doctor, nurse, psychologist, and the woman herself. The health
team promotes the empowerment of women through individual and group counseling on the
climacteric stage and health related self-care. The intervention lasts three months followed
by a three-month follow-up period to evaluate the effectiveness of the model. The
effectiveness of the model will be evaluated through the following aspects: health-related
quality of life (HR-QoL), empowerment, self-efficacy and knowledge regarding the climacteric
stage and health-related self-care activities, use of screening services, and improvement in
lifestyles (regular leisure time, physical activity and healthy diet).
The sample size for the primary outcome (HR-QoL) was estimated by using the formula to test
change in the mean of two normally distributed samples in longitudinal studies. An average
increase of at least 10 points in one or more domains of WHQ23 in the intervention group
compared with control group women was considered to be clinically relevant. The assumptions
included: a mean HR-QoL score of 64.9 points (standard deviation of 23.4 points) in the
domain of general well-being, a= 0.05 ( for one-sided hypothesis) and ? = 0.20. The number
of women by group, assuming a drop-out rate of 20% will be 107.
We also estimated a sample size for regular leisure time physical activity considering that
this is the outcome variable more difficult to achieve. It was assumed that only 17% of
women in Mexico engaged in some type of regular leisure time physical activity and a
positive increase of at least 10% will be achieved after women participation in the IHCM.
For this calculation, we used the formula to test the difference of proportions between two
populations with a= 0.05 (one side) and the power of 80%. The total number of women by group
to include assuming a drop-out rate of 20% will be 207.
Discussion: Participation in preventive activities should be encouraged among women in
Mexico. Designing and evaluating the effectiveness of an integrative health care model for
women at the climacteric stage, based on the empowerment approach and focus on
health-related self-care to improve their HR-QoL is pertinent for current health conditions
of this age group.
||Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|Behavioral:Integrative health care model|
The integrative health care model with an empowerment approach will address the care that should be given collaboratively by the health team in cooperation with the active participation of women. The IHCM will be provided under the leadership of the nurse who will coordinate with the health team members, promote preventive care, and incorporate cognitive-behavioral strategies, such as individual and group counseling. The IHCM will be provided for three months to each woman, followed by a three-month follow-up. Each woman will receive: monthly individual counseling by nurse; eight weekly (90-minutes) group counseling sessions and 2-9 consultations with psychologist defined in accordance to women individual needs and characteristics.
|Ages Eligible for Study:||45 Years|
|Genders Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Accepts Healthy Volunteers|
- Women between 45 and 59 years of age with a maximum of 5 years after menopause.
- Women affiliated with IMSS
- Agreement to participate in the study through written informed consent.
- Chronic Illnesses
- Diabetes mellitus
- Renal failure
- Liver failure
- Mental Disabilities
- Alzheimer's Disease
- Anxiety Disorder
- Bipolar Disorder
- Learning Disabilities
- Memory Loss
- Obsessive Compulsive Disorder
- Physical Disabilities
- Visual Impairment: Blindness,Blurred Vision,Cataract
- Hearing Impairment: Hearing Loss, Meniere's Disease
- Mobility Impairment: Rheumatoid Arthritis, Cerebral Palsy, Multiple Sclerosis,
Muscular Dystrophy, Paralysis, Parkinson's Disease, Stroke
- Disabling traumatic injuries