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Heart DiseasesNCT05645653

Nurse-led Medication Self-management Intervention in the Improvement of Medication Adherence

A study testing Motivational tteaching in people with Heart Diseases and CKD, run by Hamad Medical Corporation.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Back ground \& Aims Adult patients suffering from multimorbidity are at high risk of medication non-adherence. It has been well established that self-management support is an effective strategy to enhance medication adherence for patients with chronic conditions. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Heart Diseases, CKD, Diabetes
What is being tested?
Motivational tteaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
1 Dec 2022to 31 Dec 2023
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • +18 years old or over,
  • Patients with at least two of the identified comorbidities (Hypertension, Chronic painful condition, Cancer, Inflammatory connective tissue disorders, Diabetes, Lipid disorder, Dyspepsia and gastroenteritis, Heart disease, Chronic obstructive pulmonary disease, Stroke and cerebrovascular disease , chronic kidney disorder , Asthma Thyroid disorders, Anemia, Chronic liver disease, Depression, Epilepsy, Anxiety \& other stress related disorders), (3) having at least one medication prescribed for a chronic condition over at least the 3 months prior to inclusion in the study,
  • Non-adherence to medications, as defined by scoring zero on the 8-item Medication Adherence Report Scale (Morisky -8)(29),
  • Independently managing their medications (i.e., not rely on a care taker),
  • Able to speak or understand English/Arabic,
  • Able and willing to receive phone calls, and
  • Capable of providing a written informed consent to participate in the study.

Who cannot join

  • Being institutionalized in a long-term care facility,
  • Planning to move away from the community in the next 6 months,
  • Cognitive impairment (Mini-cog scores < 4), and
  • Currently participating in research involving chronic disease management. Patients with cognitive impairment are excluded because they may not be able to provide valid answers to the questionnaires.

Trial locations and contacts

No sites are listed yet.

Kalpana Singh, Ph.D contact

40258218

nkalpanasingh@gmail.com

Badriya Lenjawi, Ph.D contact

blenjawi@hamad.qa

About this study

Official title: Nurse-led Medication Self-management Intervention in the Improvement of Medication Adherence in Adult Patients With Multi-morbidity: A Feasibility Randomized Control Trial

Back ground \& Aims Adult patients suffering from multimorbidity are at high risk of medication non-adherence. It has been well established that self-management support is an effective strategy to enhance medication adherence for patients with chronic conditions. However, little is known about the effect of the medication self-management intervention in Adult patients with multimorbidity. The aim of this study to evaluate the effectiveness of a nurse-led medication self-management intervention in improving medication adherence and health outcomes in adult patients with multimorbidity.

Methods This study is a single centre, single-blind, two-arm randomised controlled trial. Adult patients with multi-morbidity will be recruited from NCCCR Qatar. A total of 100 participants will be randomly allocated to receive standard care or standard care plus the medication self-management intervention. The intervention will be delivered by clinical nurse specialists. The 6-week intervention includes three face-to-face education sessions (2st week, 4rd week and 6th week) and two weekly (8th week and 10 week) follow-up phone calls. Participants in the control group continue to receive all respects of standard care offered by healthcare providers, including chronic disease management, drug prescription, referral to hospital specialists, health education and consultations regarding patients' diseases and treatments during centre visits.

Outcome The primary outcome is medication adherence as measured by the 8-item Medication Adherence Report Scale. Secondary outcomes include medication self-management capacity (medication knowledge, medication beliefs, and medication self-efficacy), treatment experiences (medication treatment satisfaction and treatment burden). All outcomes will be measured at baseline, immediately post-intervention (7th week), and at 3-month post-intervention.

Read the detailed description

In terms of intervention we are giving six weeks motivational training ( 3 face face session and 2 telephonic follow ups).

Being tested
Motivational tteaching
Medical subject headings
Heart Diseases, Diabetes Mellitus, Neoplasms, Asthma, Thyroid Diseases, Hypertension

What participants receive

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

  • Motivational tteachingBehavioural

    A comprehensive assessment of adherence problems will be firstly conducted to identify the factors that affect adherence, including how and why these factors contribute to poor adherence. Medication-related knowledge and skills will be provided based on individual treatments and barriers to adherence. Motivational interviewing techniques will be used for a better understanding of patients' cognitive factors of adherence behavior.

Study groups in NCT05645653
Study groupRoleWhat they receive
Educational treatmentExperimentalThe medication self-management intervention consists of three face-to-face education sessions and two weekly telephone follow-up over 6 weeks. Intervention components are derived from an extensive review of the literature, including the related theoretical framework and current practice. Based on the extended IMB model of medication adherence, this intervention is designed to offer information related to medication treatment, motivate patients to adhere, help build medication self-management skills, and develop adherence improvement plans. The face-to-face meeting will take place in the clinical nurse specialist counselling room in NCCCR.
Receives: Behavioral: Motivational tteaching
Standard CareNo interventionParticipants in the control group will continue to receive standard care from Physicians, nurses, and clinical pharmacists in the NCCCR. Physicians are the primary providers and coordinators of care for patients with chronic conditions. Physicians provide patients consultations and education regarding their diseases and treatments (typically clinician-centred) at each patient visit to the chronic disease clinic.

What is being measured

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

  1. Medication Adherence

    The Morisky-8 is a self-reporting measure of unintentional and intentional medication non-adherent behaviors with a yes and no response. The total score of the moresky-8 ranges from 0 to 8, with a higher score representing higher adherence to medication. Approx 50% percentage change in medication adherence after intervention from baseline to 3 months as compared to control

    Measured: 3 months

Secondary outcomes (4)

  1. Medication Knowledge

    Change medication knowledge using The Patients' Perceived Knowledge in Medication Use Questionnaire (PKMUQ). The response scale ranges from 1 = strongly disagree to 5 = strongly agree, and the response scores of all 5 items will be summed. Higher scores indicate a higher level of medication knowledge. the score will vary from 5 to 25.

    Measured: 3 months

  2. Medication beliefs

    using the Beliefs about Medication Questionnaire (BMQ 18-item)self-reported questionnaire we will assess the medication beliefs from baseline to 3 months.

    A 5-point Likert scale ranging from 1 = strongly disagree to 5 = strongly agree is used. A higher score indicates stronger beliefs about the corresponding concepts in each subscale. the score range would be 5 to 90.

    Measured: 3 months

  3. Medication self-efficacy

    Change in Self efficacy will be assess using the SEAMS 13 items of questionnaire. Each item has a 3-point scale ranging from 1 = not confident to 3 = very confident. The score of scale ranges from 13 to 39, with a higher medication self-efficacy by a higher score.

    Measured: 3 months

  4. Treatment burden

    The change in behavior and emotional burden using MTBQ questionnaire. Each item is scored on 6-point Likert scale, ranging from 0 = does not apply to 5 = most difficult. Scores are summed to derive a total score ranging from 0 to 50 with a higher score indicating a higher level of treatment burden.

    Measured: 3 months

Timeline

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

  1. First posted9 Dec 2022
  2. Study start1 Dec 2022 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

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
Model description
This is a single Centre open label, two-arm randomized controlled trial with 1:1 randomization at the participant level. The patient population will be patients with at least two comorbidities. The patient recruitment will be done in the National Centre for Cancer Care and Research (NCCCR) in the outpatient department in the clinical nurse specialist counselling room.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05645653
Sponsor's protocol ID
296
Status last verified
Dec 2022
First submitted
20 Nov 2022
Last updated
9 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Research data will be stored on a password-protected computer and backed up on a password-protected hard drive Research Department 322A 3rd floor 302. PI and Senior Biostatistician will have the access of full data

Publications

  • Singh K, Joy GV, Al Bulushi A, Alomari AMA, Mannethodi K, Kunjavara J, Hassan N, Idris Z, Yassin MADM, Al Lenjawi B. Nurse-led medication self-management intervention in the improvement of medication adherence in adult patients with multi-morbidity: A Protocol for a Feasibility Randomized controlled trial. Glob Epidemiol. 2025 Jan 9;9:100184. doi: 10.1016/j.gloepi.2025.100184. eCollection 2025 Jun.

    PubMed 39897388

Questions about this trial

What is this clinical trial studying?

A study testing Motivational tteaching in people with Heart Diseases and CKD, run by Hamad Medical Corporation.

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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Results are not available in the source record.

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

Contact Kalpana Singh, Ph.D (40258218, nkalpanasingh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication Adherence (time frame: 3 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 NCT05645653, which also lists 1 linked publication.

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 9 Dec 2022.

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