Ignite Creation Date:
2024-05-05 @ 11:11 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01272115
Status:
COMPLETED
Last Update Posted:
2012-05-02
First Post:
2011-01-03
Brief Title:
Integrative Health Care Model for Climacteric Stage Women
Sponsor:
Coordinación de Investigación en Salud Mexico
Organization:
Coordinación de Investigación en Salud Mexico
Study Overview
Official Title:
Integrative Health Care Model for Climacteric Stage Women
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IHCM
Brief 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 andor 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 649 points standard deviation of 234 points in the domain of general well-being a 005 for one-sided hypothesis and ß 020 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 005 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
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 andor 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 649 points standard deviation of 234 points in the domain of general well-being a 005 for one-sided hypothesis and ß 020 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 005 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None