The Impact of a Pharmaceutical Care Model on Improving Polycystic Ovary Syndrome

NCT04416620 | Completed DMC

• 1 other identifier: 2017-PHA 2
• Study Type: interventional
• Target: 118
• Locations: 2 countries
• Sites: 4

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Anxiety; Depression; QOL; Biochemical parameters; Lifestyle modifications; pharmacist; PCOS

Outcome Measures

Primary Outcomes (10)

• Anxiety prevalence

  Anxiety prevalence assessment using the Beck Anxiety Inventory. The BAI scale, consisted of 21-multiple-choice questions, with 4-point scale indicating the degree of anxiety severity (0-3; all questions were scored positively). Points were summed to produce a total measure score, indicating four levels of anxiety severity: 0-7 reflecting minimal level of anxiety, 8-15 reflecting mild level of anxiety, 16-25 reflecting moderate level of anxiety and 26-63 reflecting severe level of anxiety. The possible score for each participant ranged from 0 to 63. Lower scores indicated better anxiety symptoms.

  At baseline

• Depression prevalence

  Depression prevalence assessment using the Beck Depression Inventory. The BDI is a 4-point scale (0-3) indicating the level of depression severity, with the score referring to six levels: 0-10 indicating the ups and downs reported by the participant were normal, 11-16 reflecting mild mood disturbances, 17-20 reflecting borderline clinical depression, 21-30 reflecting moderate depression, 31-40 reflecting severe depression, and over 40 reflecting extreme depression. The possible score for each participant ranged from 0 to 63. The BDI Questionnaire evaluates pessimistic attitude, loss of appetite, sad mood and feelings of guilt. Lower scores indicated better depression symptoms.

  At baseline

• Anxiety scale

  Levels of Anxiety severity and mean score assessment were done by the Beck Anxiety Inventory. The BAI scale, consisted of 21-multiple-choice questions, with 4-point scale indicating the degree of anxiety severity (0-3; all questions were scored positively). Points were summed to produce a total measure score, indicating four levels of anxiety severity: 0-7 reflecting minimal level of anxiety, 8-15 reflecting mild level of anxiety, 16-25 reflecting moderate level of anxiety and 26-63 reflecting severe level of anxiety. The possible score for each participant ranged from 0 to 63. Lower scores indicated better anxiety symptoms.

  Change from Baseline and follow-up (up to 17 weeks)

• Depression scale

  Levels of Depression severity and mean score assessment were done by the Beck Depression Inventory. The BDI is a 4-point scale (0-3) indicating the level of depression severity, with the score referring to six levels: 0-10 indicating the ups and downs reported by the participant were normal, 11-16 reflecting mild mood disturbances, 17-20 reflecting borderline clinical depression, 21-30 reflecting moderate depression, 31-40 reflecting severe depression, and over 40 reflecting extreme depression. The possible score for each participant ranged from 0 to 63. The BDI Questionnaire evaluates pessimistic attitude, loss of appetite, sad mood and feelings of guilt. Lower scores indicated better depression symptoms.

  Change from Baseline and follow-up (up to 17 weeks)

• Quality of Life scale assessment

  Quality of Life assessment using the polycystic ovary syndrome health-related QOL questionnaire (PCOSQ). It has a 30 questions about symptoms related to menstruation and mood. It can identify seven factors affecting the QOL in PCOS women including: emotional disturbance, hirsutism, weight concerns, infertility, menstrual symptoms, menstrual predictability and acne. The QOL was analyzed individually as a continuous scale out of seven to assess the QOL in patients (the higher the score is, the better the QOL is). After that, each question of the 30 questions included in the PCOSQ questionnaire was analyzed, and the mean score within each question was obtained and compared between baseline and follow-up. After that, each domain included in the QOL questionnaire was analyzed individually. Mean score of each domain was obtained and compared between baseline and follow-u to assess the impact of lifestyle modifications on that domain.

  Change from Baseline Quality of Life and follow-up (up to 17 weeks)

• Blood pressure assessment

  Systolic and diastolic blood pressure measurements were measured using the right arm, twice after a 10-min rest and averaged by using the gold standard, mercury sphygmomanometers

  Change from Baseline Blood Pressure and follow-up (up to 17 weeks)

• Blood Glucose levels

  Blood Glucose levels assessment using the Multi-parametric device.

  Change from Baseline Blood Glucose levels and Follow-up (up to 17 weeks)

• Blood Cholesterol levels

  Blood Cholesterol levels assessment using the Multi-parametric device.

  Change from Baseline Blood Cholesterol levels and follow-up (up to 17 weeks)

• Blood Triglycerides levels

  Blood Triglycerides levels assessment using the Multi-parametric device.

  Change from Baseline Blood Triglycerides levels and Follow-up (up to 17 weeks)

• Body Mass Index

  the Body Mass Index was calculated for each participant depending on their weight and hight.

  Change from Baseline Body mass index and Follow-up (up to 16 weeks)

Secondary Outcomes (2)

• Smoking frequency

  Change from Baseline Smoking frequency and Follow-up (up to 17 weeks)

• Hooka frequency

  change from Baseline Hooka frequency and Follow-up (up to 17 weeks)

Study Arms (4)

The active group of Syria

ACTIVE COMPARATOR

Participants in the active group received the 'pharmacist standard counseling' plus the 'pharmaceutical care service' designed by the research group. Both services were delivered by one female clinical pharmacist who has a Master's degree in pharmaceutical sciences, 5-year work experience in community pharmacies, and comprehensive knowledge of PCOS. The time it took to deliver the counseling and education to each participant in the active group was formally assessed. This time assessment excluded data collection and questionnaire filling time (which was planned to take around 15 min). Participants in the active group received the usual care delivered at the community pharmacies plus the pharmaceutical care service designed by the research group and provided by the clinical pharmacist. The intervention was delivered via oral advice and recommendations, and written material, with a special focus on diet and exercise.

Other: The PCOS pharmaceutical care service

The control group of Syria

NO INTERVENTION

Participants in the control group received the usual care only which is the 'pharmacist standard counseling' involved dispensing the prescribed medication (delivered by the pharmacist in charge), counseling on how to take the dispensed medications, and a brief reply to questions if asked by the participants. The 'pharmacist standard counseling' followed what was normally delivered to females with PCOS by pharmacists working at community pharmacies in both countries. This 'pharmacist standard counseling' was established based on what was observed and reported by the project research team after viewing the usual pharmacists' interaction with females with PCOS for two weeks in each country before the start of the study. Participants in the control group were informed that the educational intervention (the pharmaceutical care service) will be delivered to them after the end of the study (for ethical reasons).

The active group of Jordan

ACTIVE COMPARATOR

Participants in the active group received the usual care delivered at the community pharmacies plus the pharmaceutical care service designed by the research group and provided by the clinical pharmacist. The intervention was delivered via oral advice and recommendations, and written material, with a special focus on diet and exercise.

Other: The PCOS pharmaceutical care service

The control group of Jordan

NO INTERVENTION

Participants in the control group received the usual care only which is the 'pharmacist standard counseling' involved dispensing the prescribed medication (delivered by the pharmacist in charge), counseling on how to take the dispensed medications, and a brief reply to questions if asked by the participants. The 'pharmacist standard counseling' followed what was normally delivered to females with PCOS by pharmacists working at community pharmacies in both countries. This 'pharmacist standard counseling' was established based on what was observed and reported by the project research team after viewing the usual pharmacists' interaction with females with PCOS for two weeks in each country before the start of the study. Participants in the control group were informed that the educational intervention (the pharmaceutical care service) will be delivered to them after the end of the study (for ethical reasons).

Interventions

The PCOS pharmaceutical care service OTHER

The intervention was provided in the format of oral plus written information. The information provided included the importance of exercise and motivational messages to exercise more at home or in the gym. The 2nd part was about the importance of decreasing the stress levels. Participants were informed to perform a simple breathing exercise on daily basis twice a day. The 3rd part aimed at improving participants' diets. They were informed to follow specific diet recommendations and to avoid certain types of food, explaining to them how it may negatively affect their PCOS condition. The 4th part was about the PCOS treatment that was discussed with the participants. Females were advised on the importance of using their correct treatment. 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.

The active group of Jordan; The active group of Syria

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Females.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Applied Science Private University: lead

Study Sites (4)

Five branches of Pharmacy 1

Amman, Jordan

Location

Almazra pharmacy

Damascus, Syria

Location

Alwafaa pharmacy

Damascus, Syria

Location

Kinda Pharmacy

Damascus, Syria

Location

Related Publications (5)

• Benson S, Hahn S, Tan S, Mann K, Janssen OE, Schedlowski M, Elsenbruch S. Prevalence and implications of anxiety in polycystic ovary syndrome: results of an internet-based survey in Germany. Hum Reprod. 2009 Jun;24(6):1446-51. doi: 10.1093/humrep/dep031. Epub 2009 Feb 16.

  PMID: 19223290 RESULT

• 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.

  PMID: 19533486 RESULT

• 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.

  PMID: 18158291 RESULT

• 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.

  PMID: 20004371 RESULT

• 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.

  PMID: 17264174 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Iman A Basheti, Phd

  ASU

  PRINCIPAL INVESTIGATOR

• Kinda T Alkoudsi, Master's

  ASU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study is a single-blinded randomized controlled trial. The patients 'study groups were only known for the clinical pharmacist.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 4, 2020
• Study Start: February 1, 2017
• Primary Completion: March 1, 2017
• Study Completion: July 30, 2017
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SY (3); JO (1)