Evaluation of a New Virtual Care Pathway for Older Adults With Noncommunicable Diseases: A Pilot Study at the National University of Malaysia

NCT07843238 | Recruiting

• 2 other identifiers: JEP-2025-662NMRR ID-25-02668-EWV
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a newly developed virtual care program for older adults with chronic diseases (hypertension, diabetes and lipid disorders) whether it is feasible and economical to implement in the Malaysian primary healthcare settings. We hypothesize that the use of this virtual care program (TeleCOOP-NCD©) will be more cost-effective (lower total costs per benefits gained) compared to the usual onsite care at the clinic for older adults who have stable chronic diseases. We also hypothesize that there is no significant difference in control of clinical parameters compared to usual care. Researchers will compare the primary outcomes such as patient satisfaction, health-related quality of life, provider cost and patient cost between the intervention and control group. Researchers will also check participant recruitment rate, participant retention rate and clinical parameters (including blood pressure, hemoglobin A1c, fasting blood glucose, fasting serum lipids) as secondary outcomes. Eligible participants will receive either virtual care program (intervention) or usual care (regular in-person visits) at a primary care clinic, called the Klinik Primer of Hospital Canselor Tuanku Muhriz (KP-HCTM), in Bandar Seri Permaisuri, Kuala Lumpur, Malaysia. Researchers will do outcome assessments at baseline, 3 months and 6 months respectively.

Conditions

Hypertension (HTN); Diabetes; Dyslipidaemia

Keywords

Teleconsultation; Care Pathway; Noncommunicable diseases; Older adults; Primary care

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in Patient Satisfaction at 6 Months

  The original English version of the Patient Satisfaction Questionnaire Short Form (PSQ-18) or the validated Malay version (Ganasegeran K et al., 2014) will be used. The PSQ-18 includes 18 items covering 7 domains: general satisfaction (2 items), technical quality (4 items), interpersonal manners (2 items), communication (2 items), financial aspects (2 items), time spent with the doctor (2 items), and accessibility and convenience (4 items). All Items are scored on a 5-point Likert scale (minimum 1 and maximum 5). 9 items are to be reverse-scored. After that, overall satisfaction score will be calculated by averaging the scores from all items and the change from baseline in patient satisfaction at 6 months will be reported for each arm. The higher score means greater overall patient satisfaction.

  Baseline and 6 months

• Change from Baseline in Health-related Quality of Life (HRQoL) at 6 Months

  The EQ-5D-5L questionnaire is a validated tool to measure the HRQoL. It includes two parts: the descriptive part with five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and the visual analogue scale (EQ-VAS). Each dimension has a 5-point Likert scale (1= no problems; 5= extreme problems). These responses are combined into a single multi-attribute utility index score for each participant. Then it will be converted to the respective EQ-5D index values of individual participants by using the EQ-5D-5L value set for the Malaysian Population (minimum possible utility score= -0.442 and maximum score = 1.0; higher index values representing a better health state). The EQ-VAS allows patients to rate their overall health on the day of the assessment, with the minimum score being 0 (the worst imaginable health) and the maximum score being 100 (the best imaginable health). Higher EQ-VAS scores represent better HRQoL.

  Baseline and 6 months

• Difference in the Provider Cost between the TeleCOOP-NCD Arm and Conventional Care Arm

  The step-down costing method will be used to calculate the capital costs (for buildings and required clinic equipment which cost more than or equal to Ringgit Malaysia - RM 500) and the activity-based costing method will be used to calculate the recurrent cost incurred to operate the study site (including the costs for administration, maintenance, utilities, staff emolument and consumables). The provider cost for each arm is assessed by combing the capital costs and recurrent costs. From that, the difference in the provider cost between the two arms will be computed.

  From enrollment to the end of 6-month follow-up visit

• Difference in the Patient Cost between the TeleCOOP-NCD Arm and the Conventional Care Arm

  The direct and indirect costs related to the clinic visit will be assessed by using the cost diary for clinic visit expenditure (filled by the participants/ their caregivers) and activity-based costing method. The patient cost will be computed by combing the direct and indirect costs related to the clinic visit from the patients' perspective.

  From the enrollment to the end of 6-month follow-up visit

Secondary Outcomes (9)

• Incremental Cost-Effectiveness Ratio (ICER) of TeleCOOP-NCD versus Conventional Care

  From the enrollment to the end of 6-month follow-up visit

• Participant Recruitment Rate

  From the start of study recruitment to the anticipated completion of enrollment (estimated at 12 months)

• Participant Retention Rate

  From enrollment to the end of 6-month follow-up visit

• Change from Baseline in Systolic Blood Pressure (SBP) at 3 Months and 6 Months

  Baseline, 3 months and 6 months

• Change from Baseline in Diastolic Blood Pressure (DBP) at 3 Months and 6 Months

  Baseline, 3 months and 6 months follow-up visits

Study Arms (2)

TeleCOOP-NCD

EXPERIMENTAL

Other: Teleconsultation care pathway for older adults with NCDs (TeleCOOP-NCD©)

Conventional care

NO INTERVENTION

All participants in this conventional care arm will receive the care at the clinic as usual. They will not receive the intervention (teleconsultation by using the TeleCOOP-NCD© care pathway).

Interventions

Teleconsultation care pathway for older adults with NCDs (TeleCOOP-NCD©) OTHER

The intervention is the implementation of a newly designed teleconsultation care pathway for older patients with noncommunicable diseases (TeleCOOP-NCD©) at the primary care clinic of Hospital Canselor Tuanku Muhriz (KP-HCTM). Medical officers and Family Medicine Specialists from the KP-HCTM will provide teleconsultation to participants in the intervention arm, at 3-month and 6-month follow-up visits, according to the TeleCOOP-NCD© care pathway. Each teleconsultation may take around 30 minutes (or more, based on the individual needs of patients). There will be only two times of teleconsultations over the study period of six months for each participant under this arm. The participants can receive the teleconsultation at their homes. The appointments for the two teleconsultations will be scheduled well in advance, and they will be reminded at least one day before the appointment dates respectively.

TeleCOOP-NCD

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the age of 60 years and above;
• Patients who are literate in either Malay or English language;
• Patients who are not frail or mildly frail (with the scores of 0-8 in the Pictorial Fit-Frail Scale assessment);
• Patients who are receiving treatment for hypertension, diabetes and/or dyslipidemia (any of the three NCDs); and
• Patients who have internet access and know how to operate a smartphone/device or are able to receive assistance for its use from their family members or caregivers.

You may not qualify if:

• Patients who are completely transferred out from the Klinik Primer or Hospital Canselor Tuanku Muhriz (HCTM);
• Patients who are newly referred to the clinic and attending their first visit;
• Patients who visit the clinic for teaching sessions or non-doctor consultations (allied health, procedures, or prescription refill).

Sponsors & Collaborators

• National University of Malaysia: lead
• The Malaysian Health Economic Association (MAHEA): collaborator

Study Sites (1)

Klinik Primer - Hospital Canselor Tuanku Muhriz (KP-HCTM)

Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Dyslipidemias; Noncommunicable Diseases

Interventions

Aging

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Officials

• Aznida Firzah Abdul Aziz, MBBS, MMed, PhD

  Department of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

+60391455555; draznida@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will use the quasi-experimental study design with non-equivalent control group.

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: September 25, 2026
• Study Start: September 2, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)