State; Climacteric Clinical Trial
— IHCMOfficial title:
Integrative Health Care Model for Climacteric Stage Women
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 ß = 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.
| Status | Completed |
| Enrollment | 380 |
| Est. completion date | April 2012 |
| Est. primary completion date | April 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 45 Years to 59 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Chronic Illnesses - Diabetes mellitus - Hypertension - Renal failure - Liver failure - Cancer - Mental Disabilities - Alzheimer's Disease - Anxiety Disorder - Bipolar Disorder - Depression - Dyscalculia - Learning Disabilities - Memory Loss - Obsessive Compulsive Disorder - Schizophrenia - 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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| Mexico | Instituto Mexicano del Seguro Social | México | México DF |
| Lead Sponsor | Collaborator |
|---|---|
| Coordinación de Investigación en Salud, Mexico |
Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in health-related quality of life | Change from baseline in health-related quality of life at 3 and 6 months after the intervention, which will be measured with the revised version of Women's Health Questionnaire (WHQ23). | At 3 months and at 6 months after intervention commencement. | No |
| Secondary | Empowerment of women in relation to their self-care | Empowerment of women in relation to their self-care care measured by the empowerment scale, which was modified from the diabetes empowerment short scale to be used in climacteric women. | At baseline and at 3, 6 months after intervention commencement | No |
| Secondary | Self-efficacy of women in relation to menopause and its care | Self-efficacy of women in relation to menopause and its care will be assessed with Perimenopausal Health Self-efficacy Scale (PHS-ES). | At baseline and at 3, 6 months after intervention commencement | No |
| Secondary | Women's knowledge about the climacteric stage | Women's knowledge about the climacteric stage will be estimated with a questionnaire developed ex profeso. | At baseline and at 3, 6 months after intervention commencement | No |
| Secondary | The use of screening services | The use of screening services for: a) breast cancer by mammography in the last two years; b) cervical cancer by Pap-test in the last three years in women without a history of total hysterectomy; c) diabetes by measuring fasting plasma glucose in the last year; d) hypertension: by measuring the systolic and diastolic blood pressure in the last year. The use of screening services will be estimated as the sum of the number of screening services that women used, divided by the total number of screening services recommended according to IMSS regulations and multiplied by 100. | At baseline and at 3, 6 months after intervention commencement | No |
| Secondary | Percentage of women who practice regular leisure time physical activity | Percentage of women who practice regular leisure time physical activity (PA), where regular was defined as moderate intensity if done for = 150 minutes/week or vigorous intensity if done = 75 minutes/week. | At baseline and at 3, 6 months after intervention commencement | No |
| Secondary | Percentage of women who practice a healthy diet | Percentage of women who practice a healthy diet, which included the daily consumption of fruits (3-4 servings), vegetables (4-5 servings), and dairy products (2-3 servings). | At baseline and at 3, 6 months after intervention commencement | No |