An interventional study of Teleconsultation care pathway for older adults with NCDs (TeleCOOP-NCD©) in Hypertension (HTN), Diabetes and Dyslipidaemia, sponsored by National University of Malaysia. Recruiting at 1 site in Malaysia. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by National University of Malaysia · Not applicable, Interventional, and Health services research
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. Investigators 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. The investigators 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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 160 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
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Exclusion Criteria:
Other: Teleconsultation care pathway for older adults with NCDs (TeleCOOP-NCD©)
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).
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From the enrollment to the end of 6-month follow-up visit
Incremental Cost-Effectiveness Ratio (ICER) of TeleCOOP-NCD versus Conventional Care
The ICER of TeleCOOP-NCD versus Conventional Care will be computed as the difference in total costs between the two arms divided by the difference in the quality-adjusted life years (QALY gained). The total cost will be the sum of provider and patient costs. The QALY gained will be computed from the difference in the health-related quality of life (HRQoL assessed by the EQ-5D-5L index values) between the TeleCOOP-NCD arm and Conventional Care arm.
Time frame: From the enrollment to the end of 6-month follow-up visit
Participant Recruitment Rate
Participant recruitment rate is the average number of participants recruited per month. It will be calculated as the total number of recruited participants (numerator) divided by the total number of active recruitment months (denominator). This outcome will be reported separately for each study arm.
Time frame: From the start of study recruitment to the anticipated completion of enrollment (estimated at 12 months)
Participant Retention Rate
Participant retention rate will be defined as the percentage of participants who remain in the study and complete the 6-month follow-up visit. It will be calculated as the number of participants who complete the final assessment at the 6-month follow-up visit divided by the total number of enrolled participants. It will be reported separately for each study arm.
Time frame: 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 systolic blood pressure (SBP) will be measured at the recruitment visit. The SBP at 3-month and 6-month visits will be taken as the average of home blood pressure monitoring records (measured over at least 3 days), reported by each participant or their caregivers during each pre-visit call in the TeleCOOP-NCD arm. The SBP of participants in the conventional care arm will be measured as usual at the clinic when they attend the 3-month and 6-month follow-up visits. The change in SBP of each participant will be computed between the baseline and the two follow-up visits in both arms.
Time frame: Baseline, 3 months and 6 months
Change from Baseline in Diastolic Blood Pressure (DBP) at 3 Months and 6 Months
Baseline DBP will be measured at the recruitment visit. The DBP at 3-month and 6-month visits will be taken as the average of home blood pressure monitoring records (measured over at least 3 days), reported by each participant or their caregivers during each pre-visit call in the intervention arm. The DBP of participants in the control arm will be measured as usual at the clinic when they attend the 3-month and 6-month follow-up visits. The change in DBP of each participant will be computed between the baseline and the two follow-up visits in both arms.
Time frame: Baseline, 3 months and 6 months follow-up visits
Change from Baseline in Hemoglobin A1c (HbA1c) at 6 Months
The hemoglobin A1c (HbA1c) values of participants with diabetes within the last two weeks before recruitment will be taken as the baseline HbA1c values. The mean difference in HbA1c between baseline and 6-month follow-up visit will be computed for participants with diabetes in both arms. Based on the clinical conditions of each participant, their attending doctors may decide not to check the HbA1c level at any visit in both arms. Participants without diabetes will be assessed for this outcome measure.
Time frame: Baseline and 6 months
Change from Baseline in Fasting Blood Glucose (FBS) Levels at 3 Months and 6 Months
The most recent fasting blood glucose (FBS) level within two weeks before recruitment or at the time of recruitment will be taken as the baseline FBS level. At least one day before the follow-up appointments, the participants with diabetes in the TeleCOOP-NCD arm will be reminded to report their most recent FBS levels to their attending doctors during the 3-month and 6-month teleconsultation visits respectively. The FBS levels for those with diabetes in the conventional care arm will be checked as usual at the 3-month and 6-month visits. The mean difference in FBS between baseline, 3-month and 6-month visits will be calculated in both arms. Based on the clinical conditions of each participant, their attending doctors may decide not to check the FBS level at any visit in both arms. Participants without diabetes will be assessed for this outcome measure.
Time frame: Baseline, 3 months and 6 months
Change from Baseline in Total Cholesterol Levels at 6 Months
The recent total cholesterol (TC) result within two weeks before the recruitment visit will be taken as the baseline TC level. The mean difference in TC levels of each participant between the baseline and 6-month follow-up visit will be computed in each arm. Based on the clinical conditions of each participant, their attending doctors may decide not to check the TC level at any visit in both arms.
Time frame: Baseline and 6 months
Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 6 Months
The recent low-density lipoprotein cholesterol (LDL-C) result within two weeks before the recruitment visit will be taken as the baseline LDL-C level. The mean difference in LDL-C levels of each participant between baseline and 6 months will be computed in each arm. Based on the clinical conditions of each participant, their attending doctors may decide not to check the LDL-C level at any visit in both arms.
Time frame: Baseline and 6 months
Plan to share: No
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