Clinical trial NCT04416620: The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome
Official title: The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome Associated Factors Amongst Females in Jordan and Syria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Anxiety
Depression
QOL
Biochemical parameters
Lifestyle modifications
pharmacist
PCOS
Lead sponsor: Applied Science Private University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 118
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants in the active group received the usual care delivered at the community pharmacies at both countries plus the pharmaceutical care service designed by the research group and provided by the clinical pharmacist, an experienced female with extensive knowledge on PCOS. The intervention was delivered via oral advice and recommendations, and written material, with a special focus on diet and exercise. Participants in the control group received the usual care only and did not receive the pharmaceutical care service.

Following the intervention, both groups were followed up for four months and re-interviewed at the community pharmacy.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary aim of this study was to estimate the prevalence of anxiety disorder and depression amongst Syrian and Jordanian women who are suffering from PCOS in Damascus and Amman.

The secondary aim was to assess the effectiveness of a PCOS pharmaceutical care service on selected patient's biochemical parameters, QOL, anxiety, and depression scale. The third aim is to identify the factors associated with QOL, anxiety and depression scores' change across the study.

Null Hypothesis (research hypothesis):

The intervention of PCOS pharmaceutical care service will lead to no significant differences in patient's depression, anxiety, QOL, and some biochemical parameters in comparison to females who will not receive this intervention in both Syria and Jordan.

Alternative Hypothesis (research hypothesis):

The intervention of PCOS pharmaceutical care service will have a significant impact on patient's depression, anxiety, QOL, and some biochemical parameters in comparison to patients who will not receive this intervention in both Syria and Jordan.

Detailed description: The information provided in the PCOS pharmaceutical care service was delivered in the format of oral plus written information (most important facts to remember and take-home messages regarding lifestyle modifications). The information provided included the importance of exercise and motivational messages to exercise more at home or in the gym. Participants were informed of previous study results which showed that 8-12 weeks of exercise can ameliorate cardiovascular risk factors and improve mental health.

The second part of the educational service was about the importance of decreasing the stress levels. The participants were informed that markers of oxidative stress were found to be out of range in PCOS women and that it was proven beneficial to do breathing exercises to reduce stress. It was clarified that the breathing exercise does not only relieve stress but also may help to gain better sleep and relieve anxiety symptoms. Participants were informed to perform a simple breathing exercise on daily basis (twice a day, morning and night) where they inhale through the nose for the account of four, and then exhale through the nose for the count of four, with the possibility to increase the counting to 6 then to 8.

The third part of the educational service aimed at improving participants' diets. They were informed to follow specific diet recommendations as follows:

to consume the majority of their daily calories prior to 12 pm (shown to improve insulin and glucose levels and decrease testosterone levels), to focus on food with low glycemic load e.g. chicken, meat, eggs and avocado (shown to decrease insulin levels).

to increase their vitamin C and calcium intake e.g. kiwi, orange and lemons (shown to improve body mass index and menstrual abnormalities, along with other PCOS-related symptoms).

to include adequate magnesium intake in their diet e.g. legume, spinach, broccoli, banana and pineapple (shown to lower the risk of heart disease, diabetes, and stroke).

to increase chromium intake, found in onions, garlic, grapefruit and tomatoes (shown to help regulate insulin and glucose levels).

to increase their consumption of omega-3, found in food such as tuna, salmon, fish, and walnuts (shown to help in decreasing androgen levels and testosterone).

In addition, participants were informed to avoid or to minimize certain types of food, explaining to them how it may negatively affect their PCOS condition. Such food types included caffeine beverages (as it may increase the estrogen level and affect fertility).

hydrogenated oils including margarine, corn oil, and coffee creamers (as it decreases the HDL (the good cholesterol), and increases the LDL (the bad cholesterol).

white sugary foods like cookies, cakes, and candies (as it can increase glucose levels).

dairy products (since it can cause allergic reactions and digestion problems, in addition to raising the testosterone levels).

Processed food (because it has a negative effect on insulin level). PCOS treatment was also discussed (orally only) with the participants (Fourth part of the service). Females were advised on the importance of using their correct treatment, for example using the pill for hormonal balance. They were informed of the importance of adhering to their prescribed medications, accepting that it was a long term treatment plan, and to consult with their specialist if their treatment was not effective, or in the case of medication side effects.

Eligibility criteria: Inclusion Criteria:

* Females who had a doctor-diagnosis of PCOS.
* Above the age of 16.
* Able to complete the 4-month study.

Exclusion Criteria:

* Females with an old diagnosis of PCOS with no doctor visit in the past month.
* Can not speak and understand Arabic.

Primary outcomes:
measure: Anxiety prevalence
timeFrame: At baseline
measure: Depression prevalence
timeFrame: At baseline
measure: Anxiety scale
timeFrame: Change from Baseline and follow-up (up to 17 weeks)
measure: Depression scale
timeFrame: Change from Baseline and follow-up (up to 17 weeks)
measure: Quality of Life scale assessment
timeFrame: Change from Baseline Quality of Life and follow-up (up to 17 weeks)
measure: Blood pressure assessment
timeFrame: Change from Baseline Blood Pressure and follow-up (up to 17 weeks)
measure: Blood Glucose levels
timeFrame: Change from Baseline Blood Glucose levels and Follow-up (up to 17 weeks)
measure: Blood Cholesterol levels
timeFrame: Change from Baseline Blood Cholesterol levels and follow-up (up to 17 weeks)
measure: Blood Triglycerides levels
timeFrame: Change from Baseline Blood Triglycerides levels and Follow-up (up to 17 weeks)
measure: Body Mass Index
timeFrame: Change from Baseline Body mass index and Follow-up (up to 16 weeks)
Secondary outcomes:
measure: Smoking frequency
timeFrame: Change from Baseline Smoking frequency and Follow-up (up to 17 weeks)
measure: Hooka frequency
timeFrame: change from Baseline Hooka frequency and Follow-up (up to 17 weeks)
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Five branches of Pharmacy 1
city: Damascus
country: Syrian Arab Republic
facility: Almazra pharmacy
city: Damascus
country: Syrian Arab Republic
facility: Alwafaa pharmacy
city: Damascus
country: Syrian Arab Republic
facility: Kinda Pharmacy
Study officials:
affiliation: ASU
name: Iman A Basheti, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: ASU
name: Kinda T Alkoudsi, Master's
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Laggari V, Diareme S, Christogiorgos S, Deligeoroglou E, Christopoulos P, Tsiantis J, Creatsas G. Anxiety and depression in adolescents with polycystic ovary syndrome and Mayer-Rokitansky-Kuster-Hauser syndrome. J Psychosom Obstet Gynaecol. 2009 Jun;30(2):83-8. doi: 10.1080/01674820802546204.
citation: Palomba S, Giallauria F, Falbo A, Russo T, Oppedisano R, Tolino A, Colao A, Vigorito C, Zullo F, Orio F. Structured exercise training programme versus hypocaloric hyperproteic diet in obese polycystic ovary syndrome patients with anovulatory infertility: a 24-week pilot study. Hum Reprod. 2008 Mar;23(3):642-50. doi: 10.1093/humrep/dem391. Epub 2007 Dec 23.
citation: Thomson RL, Buckley JD, Lim SS, Noakes M, Clifton PM, Norman RJ, Brinkworth GD. Lifestyle management improves quality of life and depression in overweight and obese women with polycystic ovary syndrome. Fertil Steril. 2010 Oct;94(5):1812-6. doi: 10.1016/j.fertnstert.2009.11.001. Epub 2009 Dec 11.
citation: Vigorito C, Giallauria F, Palomba S, Cascella T, Manguso F, Lucci R, De Lorenzo A, Tafuri D, Lombardi G, Colao A, Orio F. Beneficial effects of a three-month structured exercise training program on cardiopulmonary functional capacity in young women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2007 Apr;92(4):1379-84. doi: 10.1210/jc.2006-2794. Epub 2007 Jan 30.