Clinical trial NCT05645653: Nurse-led Medication Self-management Intervention in the Improvement of Medication Adherence
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Diseases
CKD
Diabetes
Cancer
Asthma
Thyroid
Hypertension
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Medical Research Council
First posted: 2022-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Medication Adherence
timeFrame: 3 months
Secondary outcomes:
measure: Medication Knowledge
timeFrame: 3 months
measure: Medication beliefs
timeFrame: 3 months
measure: Medication self-efficacy
timeFrame: 3 months
measure: Treatment burden
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: