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Systemic Lupus ErythematosusADELESNCT02330250

Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment

A study testing Pharmaceutical Care in people with Systemic Lupus Erythematosus and Medication Adherence, run by Oswaldo Cruz Foundation at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project aims to improve adherence rate through pharmaceutical care in patients with systemic lupus erythematosus (SLE) to help achieving therapeutic goals and finally to improve the quality of life of these patients. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pharmaceutical Care
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
131 participants
Where
1 siteBrazil
Study dates
Jul 2014to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • SLE diagnosis according to the 2012 SLICC (Systemic Lupus International Collaborating Clinics Group) SLE classification criteria.
  • Treatment with corticosteroids and antimalarials.
  • History of biopsy-proven lupus nephritis classes III, IV, or V (2003 International Society of Nephrology / Renal Pathology Society) or nephritic/nephrotic lupus flare not undergone to kidney biopsy.

Who cannot join

  • Current renal replacement therapy.
  • Renal transplantation.
  • Ongoing pulse therapy with cyclophosphamide and/or methylprednisolone.
  • Aid by caregiver.
  • Any psychiatric illness.
  • Inability to understand the questions of the questionnaire.
  • Patients'unwillingness to sign the informed consent.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Reumathology outpatient clinics Pedro Ernesto University Hospital

    Rio de Janeiro, Rio de Janeiro, 20.551-030

Other trials in Brazil

About this study

Official title: Effectiveness of Pharmaceutical Care in the Adherence of Systemic Lupus Erythematosus Treatment in Rio de Janeiro: a Randomized Clinical Trial

This project aims to improve adherence rate through pharmaceutical care in patients with systemic lupus erythematosus (SLE) to help achieving therapeutic goals and finally to improve the quality of life of these patients.

Read the detailed description

Adherence to treatment is a primary determinant for the effectiveness of health care. Non-compliance may lead to therapeutic failure, make more difficult and complex the management of chronic diseases or cause death. The effectiveness of interventions on adherence has an important impact in the health of the population. Systemic lupus erythematosus (SLE) is an autoimmune disease with high proportion of hospital admissions and deaths and high cost of treatment. The prevalence of adherence in this group of patients in Brazil is very low (31.7%) and the drug treatment is complex. Our aim is to assess the effectiveness of Pharmaceutical Care in the adherence of drug treatment by SLE patients attended in a Rheumatology outpatient clinic in Rio de Janeiro, Brazil.

Randomized clinical trial (pragmatic trial), in which 120 adult patients with confirmed SLE diagnosis will be followed for 12 months, and randomized in two groups: the intervention group (attended by a pharmacist according to the Dader Method for Pharmaceutical Care), and the control group (attended by a non-pharmacist professional with counseling on hygiene/nutrition and reduction of risks in lupus therapy). The main outcome will be adherence to drug therapy and secondary outcomes the improvement of the medical condition and the quality of life of the patients.

Being tested
Pharmaceutical Care, Control
Keywords
Systemic Lupus Erythematosus, Pharmaceutical care, Pharmaceutical services, Medication adherence
Medical subject headings
Lupus Erythematosus, Systemic, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pharmaceutical CareOther

    Also called Pharmaceutical Services

    The patients assigned for the intervention group will receive guidance from a pharmacist ("pharmaceutical consultation") in addition to the medical care habitually delivered by the hospital.

    The pharmacist will review the drug therapy, identifying current and potential problems related to the drug prescription, making a systematic assessment of the need, effectiveness and safety of all medications and their adequacy to the patient's life routine. A care plan will then be designed along with the patient that may include interventions and/or referral to other practitioners.

  • ControlOther

    The patients assigned to the control group will receive the medical care habitually provided by the hospital and will be attended by a non-pharmacist professional, who will provide hygiene/nutritional counseling and risk reduction, such as smoking cessation advice; use of estrogen-based contraceptive drugs; exposure to sunlight, proper use of sunscreen and clothes; nutritional guidance on the intake of low saturated-fat food. As usual, information about the use of medication will be provided by the attending physician.

Study groups in NCT02330250
Study groupRoleWhat they receive
Pharmaceutical CareExperimentalThe patients will receive guidance from a pharmacist based on the Dader Method for Pharmaceutical Care, in addition to the medical care habitually delivered by the hospital.
Receives: Other: Pharmaceutical Care
ControlSham comparatorThe control group will receive the medical care habitually provided by the hospital, and the follow-up by a non-pharmacist professional.
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medication adherence

    Medication adherence will be measured by use of the eight-item Morisk Medication Adherence Scale (MMAS) translated and validated to brazilian portuguese

    Measured: 12 months

Secondary outcomes (2)

  1. SLE disease activity

    SLE disease activity measured by use of Safety of Estrogens in Systemic Lupus National SLE Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)

    Measured: 12 months

  2. Quality of life

    Quality of life measured by use of Medical Outcomes Study 36 - Item Short-Form Health Survey)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2015 (estimated)
  2. Study startJul 2014
  3. Primary completionFeb 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02330250
Sponsor's protocol ID
ADELES/002
Acronym
ADELES
Status last verified
Jun 2016
First submitted
30 Dec 2014
Last updated
24 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • de Oliveira-Filho AD, Morisky DE, Neves SJ, Costa FA, de Lyra DP Jr. The 8-item Morisky Medication Adherence Scale: validation of a Brazilian-Portuguese version in hypertensive adults. Res Social Adm Pharm. 2014 May-Jun;10(3):554-61. doi: 10.1016/j.sapharm.2013.10.006. Epub 2013 Oct 26.

    PubMed 24268603

  • Silva C, Canhao H, Barcelos A, Miranda L, Pinto P, Santos MJ. [Protocol for evaluation and monitoring of Systemic Lupus Erythematosus (PAMLES)]. Acta Reumatol Port. 2008 Apr-Jun;33(2):210-8. Portuguese.

    PubMed 18604187

  • Campolina AG, Ciconelli RM. [SF-36 and the development of new assessment tools for quality of life]. Acta Reumatol Port. 2008 Apr-Jun;33(2):127-33. Portuguese.

    PubMed 18604180

  • Oliveira-Santos M, Verani JF, Klumb EM, Albuquerque EM. Evaluation of adherence to drug treatment in patients with systemic lupus erythematosus in Brazil. Lupus. 2011 Mar;20(3):320-9. doi: 10.1177/0961203310383736. Epub 2010 Dec 23.

    PubMed 21183558

  • Barber N, Parsons J, Clifford S, Darracott R, Horne R. Patients' problems with new medication for chronic conditions. Qual Saf Health Care. 2004 Jun;13(3):172-5. doi: 10.1136/qhc.13.3.172.

    PubMed 15175485

  • Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.

    PubMed 22553077

  • Oliveira-Santos M, Verani JF, Camacho LA, de Andrade CA, Ferrante-Silva R, Klumb EM. Effectiveness of pharmaceutical care for drug treatment adherence in patients with systemic lupus erythematosus in Rio de Janeiro, Brazil: study protocol for a randomized controlled trial. Trials. 2016 Apr 2;17:181. doi: 10.1186/s13063-016-1317-1.

    PubMed 27038611

Questions about this trial

What is this clinical trial studying?

A study testing Pharmaceutical Care in people with Systemic Lupus Erythematosus and Medication Adherence, run by Oswaldo Cruz Foundation at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication adherence (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02330250, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.

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