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Status unknownNCT05645653Updated Dec 9, 2022

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

An interventional study of Motivational tteaching in Heart Diseases, CKD and Diabetes, sponsored by Hamad Medical Corporation. Status unknown. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-12-09.

Sponsored by Hamad Medical Corporation · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
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Study 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. 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).

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Conditions studied

  • Heart Diseases
  • CKD
  • Diabetes
  • Cancer
  • Asthma
  • Thyroid
  • Hypertension

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03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 1,779 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Hamad Medical Corporation is the lead sponsor of 133 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • +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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Educational treatment

    The 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.

    Behavioral: Motivational tteaching

  • No intervention
    Standard Care

    Participants 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.

Interventions

  • BehavioralMotivational tteaching

    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.

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What researchers measure

Primary outcomes

  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

    Time frame: 3 months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 3 months

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Study locations

No study locations are listed for this record.

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References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 2, 2022
  • Informed consent form · Nov 2, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05645653
Lead sponsor
Hamad Medical Corporation
Collaborators
Medical Research Council
Responsible party
Dr. Kalpana Singh (Senior epidemiologist, Hamad Medical Corporation) — Principal investigator
First posted
Dec 9, 2022
Start date
Dec 1, 2022 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Dec 9, 2022

Study contacts

Kalpana Singh, Ph.D
Contact
nkalpanasingh@gmail.com
40258218
Badriya Lenjawi, Ph.D
Contact
blenjawi@hamad.qa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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