Integrative Health Care Model for Climacteric Stage Women
Condition: State; Climacteric
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Integrative health care model
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Climacteric stage; Integrative health care model; Empowerment approach; Primary care services