The Effect of Chronic Care Model Based Education on Disease Management in Hypertensive Patients

NCT04411355 | Completed

• 1 other identifier: 494582
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: This study was conducted to examine the effect of planned educational intervention based on The Chronic Care Model (CCM) on the management of hypertension in patients with hypertension. The Chronic Care Model is a framework for organizing and improving chronic illness care, based on a proactive, planned approach that incorporates patient self-care, provider, and system level interventions. Several instruments have been developed to evaluate the effects of CCM implementation on care and treatment outcomes.The Patient Assessment of Chronic Illness Care (PACIC) questionnaire is used in instrument to evalate the delivery of care for patients. Methods: The study was performed a prospective and conducted with a controlled semi-experimental pattern in matched groups. 30 patients including 15 intervention and 15 control group patients matched in terms of socio-demographic features were monitored for six months. The intervention group was trained and monitored by a professional team in line with the components of the model. Life quality scale, hypertension information questions and chronic care assessment scale were applied to both groups at the beginning and in the sixth month of the study. Trial registration: The study was conducted in accordance with the World Medical Association Declaration of Helsinki of 1964, and approved by local authorities and local Bioethics Committees(BC) in participating university hospital. (Ethics committee approval No:B.30.2.EGE.0.20.05.00/OY/649/268 Decision No: 13-3.3/12) Permissions for the use of scale of PACIC and model of CCM were taken via e-mail. Key Words: nursing; chronic care model; hypertension

Conditions

Hypertension

Keywords

nursing; chronic care model; hypertension

Outcome Measures

Primary Outcomes (3)

• The Patient Assessment of Chronic Illness Care (PACIC)

  The tool was developed in 2005 by Glasgow and is allowing the evaluation of health care services offered to chronic patients by patients,easy to apply,20 items short tool.PACIC,created in line with the basic 6 elements of the CCM,consists of 5 subdimensions;\*Patient Activation (items 1-3),\*Delivery System Design/Decision Support (items 4-6),\*Goal Setting (items 7-11),\*Problem-solving/Contextual Counseling (items 12-15),\*Follow-up/Coordination (items 16-20).The total score of the scale is calculated by the average score of all 20 items.The average score of each sub-dimension are measured by a 5-point Likert-type grading. The increase in scale scores indicates that individuals with chronic diseases have high satisfaction with the care patients receive and that chronic disease management is sufficient.The validity and reliability of theTurkish version of the scale was done by İncirkuş and Nahcivan(2010).

  6 months

• WHOQOL-BREF(TR) quality of life assessment

  The WHOQOL-BREF(TR)scale developed from WHOQOL-100 to evaluate the quality of life.The cultural adaptation of the scale inTurkey performed by Eser(1999).The Turkish versionof the scale,27th question,national environmental area has been added as"Area V"; Area I:Physical area:To be able to carry out daily tasks,dependence on drugs, treatment, vitality,fatigue,physical activity,pain,discomfortsleep,rest,ability to work. Area II:Mental area:Body image and appearance,negative emotions,memory, distraction. Area III:Social relations area:Relations with other people,social support,sexual life. Area IV:Environmental area:Financial resources,physical security,accessibility to health services,home environment,opportunity to use rest,leisure time,physical environment, transportation. Area V:National environmental area:cultural area The total score is range from a min.of 27 to a max.of 135.

  6 months

• Hypertensive nephropathy

  The reduced glomerular filtration rate (eGFR). GFR rate is calculated using a mathematical formula that compares a person's size, age, sex, and race to serum creatinine levels. A normal GFR 60 mL/min/1.73 m² .the lower the GFR number, the worse the kidney function.

  6 months

Secondary Outcomes (3)

• HbA1c levels as the clinical indicator

  3. and 6. month

• Blood glucose levels as the clinical indicator

  6. month

• The indicator of perfusion to vital organs

  6. month

Study Arms (2)

control group patients

NO INTERVENTION

non intervention. only rutin care

intervention group patients

EXPERIMENTAL

The intervention group was trained and monitored by a professional team in line with the components of the model. Life quality scale, hypertension information questions and chronic care assessment scale were applied to both groups at the beginning and in the sixth month of the study.

Dietary Supplement: control by dietitian; Other: Exercise programs; Behavioral: control by psychiatrist

Interventions

control by dietitian DIETARY_SUPPLEMENT

Also known as: behavioral

intervention group patients

Exercise programs OTHER

In line with the address information of the intervention patients, purpose/content of the study was discussed with the gyms of municipalities and patients were made to benefit from these facilities for free. For the patients preferring private gyms, it was ensured that discounts were made for the patients.

intervention group patients

control by psychiatrist BEHAVIORAL

The psychiatrist assessed the suitability of the patients to the study, assessed the patients having adaptation problems with respect to lifestyle changes in monthly controls and also played roles in teaching the coping methods to patients and applying and interpreting the hospital anxiety and depression scale.

intervention group patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being literate
• No sensory losses such as vision and hearing
• Willingness to participate in the study
• Being open to communication and cooperation
• Internet access and availability
• To have a phone that can be reached
• Having a diagnosis of hypertension at least 6 months ago
• According to JNC-6,1997 classification, high blood pressure level is normal, stage 1,2 and 3, risk group A and B, no additional organ damage
• Not having metabolic disturbances or diseases that prevent to from participating in the study.

Sponsors & Collaborators

• Ege University: lead

Related Links

• National Thesis Center

MeSH Terms

Conditions

Hypertension

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Huseyin Töz, prof

  Deparment of Nephrology of Ege University Hospital

  STUDY DIRECTOR

• Asiye Durmaz Akyol

  Faculty of Nursing of Ege University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: controlled semi-experimental design in matched groups

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: June 2, 2020
• Study Start: December 15, 2012
• Primary Completion: February 15, 2014
• Study Completion: April 15, 2016
• Last Updated: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: open-ended
• Access Criteria: unconditional