Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444074
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-30
Brief Title:
The PACT Patient Activation Through Conversations Study
Sponsor:
National Healthcare Group Polyclinics
Organization:
National Healthcare Group Polyclinics
Study Overview
Official Title:
The PACT Patient Activation Through Conversations Study - A Cluster Randomised Trial of a Health Coach-led Patient Activation Program in Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACT
Brief Summary:
The PACT Study is a cluster randomised trial of a health coach-led patient activation program in type 2 diabetes The goal of this clinical trial is to evaluate the effectiveness of a health coaching intervention PACT program led by Care Coaches trained lay persons in adult participants with sub-optimally controlled Diabetes Mellitus as compared to participants undergoing routine care for diabetes Usual Care
The primary outcome of interest is change in Glycated Haemoglobin HbA1c levels over 3 months 6 months and 12 months Secondary outcomes include changes in blood pressure low-density lipoprotein-cholesterol LDL-C levels body mass index BMI self-reported diabetes self-care behaviours self-efficacy health-related quality of life and diabetes-related distress over 3 6 and 12 months
Participants in the Intervention arm will undergo the PACT Program which is a 3-month long health coaching program led by a care coach Participants review their motivators health parameters self-care behaviours and set goals for improving their diabetes using a PACT report Subsequently they will receive fortnightly motivational and problem solving support via telephone or WhatsApp messaging over a 3-month duration and will return to routine care after 3 months Participants in the Usual Care arm will have routine care of their diabetes treatment
The primary outcome of interest is change in Glycated Haemoglobin HbA1c levels over 3 months 6 months and 12 months Secondary outcomes include changes in blood pressure low-density lipoprotein-cholesterol LDL-C levels body mass index BMI self-reported diabetes self-care behaviours self-efficacy health-related quality of life and diabetes-related distress over 3 6 and 12 months
Participants in the Intervention arm will undergo the PACT Program which is a 3-month long health coaching program led by a care coach Participants review their motivators health parameters self-care behaviours and set goals for improving their diabetes using a PACT report Subsequently they will receive fortnightly motivational and problem solving support via telephone or WhatsApp messaging over a 3-month duration and will return to routine care after 3 months Participants in the Usual Care arm will have routine care of their diabetes treatment
Detailed Description:
Study Methodology
This is a cluster randomised controlled trial comparing the PACT program to Usual Care Each cluster consists of a Teamlet in a NHG Polyclinic consisting of a regular group of Family Physicians a Care Manager and a Care Coordinator that provide chronic care for a regular group of about 5000 patients
Study Population
The study population will include patients with suboptimal control of diabetes HbA1c 8 between the ages of 21 to 64 Patients with a suboptimal control of diabetes frequently require a combination of both pharmacological and lifestyle measures for improvement of their glycaemic levels
The inclusion criteria include the following
Individuals with a diagnosis of Type 2 Diabetes Mellitus who are enrolled in Teamlets in NHGP
Age between 21 to 64 years old
HbA1c level of more than 8 in the last 6 months
The exclusion criteria includes the following
History of acute coronary syndrome in the past 3 months
History of stroke or transient ischaemic attacks in the past 3 months
History of end stage organ failure liver cirrhosis cardiac failure latest eGFR 30 mLmin173m2 in the last 6 months
Cancer requiring treatment in the past 5 years
Active psychiatrist follow up
Social issues that are significant enough for follow-up or referral with a medical social worker within the last 12 months
Women who are pregnant or breastfeeding
Patients who are enrolled in other current diabetes-related interventional studies
Inability to provide written consent for the study protocol and able to commit to the study duration
These patients are excluded as they may have conditions that could be of a higher priority for management as compared to Diabetes Mellitus and may not be able to provide informed consent or participate actively in shared decision making
Summary of Study Design
The unit of randomisation will be each cluster as represented by a single Teamlet Randomisation will be carried out on all Teamlets that are involved in this research study from NHG Polyclinics The study team aims to involve two to three polyclinics that includes six Teamlets in each polyclinic A total of 12 to 18 Teamlets will hence be involved subject to resource and recruitment considerations
Teamlets in each polyclinic will be randomised to either the PACT Program condition or Usual Care condition Patients who belong to Teamlets that are randomised to the PACT Program condition will be recruited for participation in the PACT Program and patients who belong to Teamlets that are randomised to the Usual Care condition will be recruited and provided with routine care Due to the nature of the PACT intervention blinding of the Teamlet members Doctor Care Manager Care Coach and patients will not be feasible The data analyst will be blinded to the group allocation
The PACT Program intervention will last 3 months Four participant assessments will be conducted and this will take place at baseline and at the 3-month 6-month and the 12-month mark
Recruitment of participants will take place over 12 months and follow-up of participants will be carried out over 24 months Further analysis will be undertaken for 12 months so the total length of the study will be 4 years and 0 months
PACT program procedures The PACT program lasts 3 months and is a health coaching program for people with type 2 diabetes
Patients have an in-person visit with a Care Coach at the baseline visit where review of their metabolic parameters self-care behaviors and health motivators is carried out supported by use of a PACT form This is followed by goal setting
The PACT form consists of
1 Results of patients latest clinical readings are shared with the patient
2 Patient fills in their key motivators for managing their diabetes well
3 Patient fills in a survey that assesses their own self-care behaviors diet exercise medication adherence diabetes distress
4 Goal setting with the care coach to set SMART specific measurable achievable relevant and time-sensitive goals
The Care Coach has been trained to apply a bio-psychosocial approach motivational interviewing skills and provide diabetes care support The discussion will take approximately 15 to 30 minutes
Supportive follow-up is provided over the following 3 months The Care Coach will support patients in reviewing their goals assist in problem solving and provide motivational support Follow-up will be conducted 2 weekly via telephone calls andor WhatsApp messages according to the patients preference Care coaches will minimally send patients a whatsapp message or conduct a phone call however we acknowledge that some patients may not reply or pick up the phone This will take approximately 10 to 20 minutes each time After 3 months the patients will be reverted back to routine clinical care
Outcome Assessments
Patient outcomes will be assessed at baseline 12 months before study period and at regular intervals over 24 months for clinical data Patient reported outcomes will be assessed at 3 6 and 12 months
1 Clinical Outcomes
Clinical outcomes will be extracted from the NHGP Business Intelligence database from routinely collected data
The outcomes that will be assessed include
Clinical outcomes at baseline and follow-up HbA1c systolic and diastolic blood pressure body mass index Total cholesterol HDL-cholesterol LDL-cholesterol and Triglyceride levels serum creatinine level estimated glomerular filtration rate urine albumin-creatinine ratio and the urine protein-creatinine ratio
At baseline Presence of co-morbidities which include hypertension hyperlipidaemia ischaemic heart disease stroke peripheral vascular disease previous lower limb amputations chronic kidney disease diabetic neuropathy and diabetic retinopathy
Patients usually make clinic visits every 3 to 6 months Clinical outcomes data will be obtained for baseline and over a period of 24 months
2 Patient reported outcomes
Patient reported outcomes will be assessed using a questionnaire at baseline at the 3-month mark 6-month mark and at the 12-month mark
The questionnaire will be self-administered with interviewer assistance on patient request
The baseline and follow-up questionnaires include the following measures
Sociodemographic information - Only in baseline questionnaire
Self-care behaviours measured with the Summary of Diabetes Self-Care Activities scale SDSCA
Diabetes-related distress measured with the 2-item Diabetes Distress Scale DDS-2
Diabetes empowerment measured with the short form of the Diabetes Empowerment Scale DES-SF
Health-related quality of life measured with the EQ-5D-5L
Patient satisfaction as measured by 5 questions from the Patient Satisfaction Questionnaire-III- Only in the PACT 3-month questionnaire
3 Referral to community exercise programs As part of comprehensive lifestyle management the patients may be directed to community exercise programs such as those run by SportSG Attendance to such programs will be recorded via patient-reported information in the 3-month 6-month and 12-month questionnaires
4 Adverse events Improvements in self-care behaviors diet and physical activity may be associated with hypoglycaemic symptoms Monitoring for serious hypoglycaemic episodes requiring emergency department visit andor admissions to hospital will be recorded via patient-reported information the 3-month 6-month and 12-month questionnaires
5 Drugs Prescribed Drugs could affect clinical outcomes such as HbA1c Information such as drug prescribed dosage and cost of medications will be extracted from NHGP Business Intelligence database
6 Resources and Cost
Costs and resource utilisation will be analysed including
Health-service utilisation costs including Medical Doctor Nursing Care Manager Allied Health Dietician Psychologist Medical Social Worker consultation sessions
Training and utilisation costs for the Care Coaches including the number of TelephoneWhatsApp follow-up calls by the Care Coaches
Laboratory tests
Medication costs
Sample Size and Statistical Methods
Estimation of Sample Size A minimal clinically important difference of 04 in HbA1c is expected between participants of the PACT program compared with Usual Care In estimating the sample size a standard deviation of 12 was used as estimated from a local study We aim to recruit between 12 to 18 Teamlets in the study If 12 Teamlets are recruited 6 Teamlets are randomised to PACT and 6 to the control group 34 subjects are required for each Teamlet total 204 participants in the PACT program and 204 participants in Usual Care at 80 power with one-sided alpha at 5 and setting the intracluster correlation coefficient at 001 with an assumed drop-out rate of 20 If 18 Teamlets are recruited 9 randomised to PACT and 9 to the control group 24 subjects are required for each Teamlet 216 participants in the PACT program and 216 participants in Usual Care at 80 power with one-sided alpha at 5 and setting the intracluster correlation coefficient at 001 with an assumed drop-out rate of 20 Sample size calculations were conducted using SampSizeV2
Statistical and Analytical Plans
1 Clinical Outcomes evaluation Categorical data will be summarized as counts percentage while continuous data will be summarized as mean standard deviation if they are normally distributed or median interquartile range if they are skewed Baseline characteristics will be compared between participants in the PACT program and Usual care Differences in the outcomes of interest clinical and patient-reported at different data points will be compared between participants in the PACT program and Usual Care As this is a cluster-randomised trial a mixed model will be used to evaluate the longitudinal difference-in-difference outcomes between the PACT program and Usual Care incorporating Teamlets as the random effect Relevant baseline covariates will be included in the model to account for potential confounding factors
2 Resource and cost evaluation This study will analyse the cost-effectiveness and resource utilisation of the PACT program The potential economic impact of new program implementation will be studied by estimating the incremental cost effectiveness ratio ICER between PACT and Usual Care incremental direct medical cost per unit improvement in clinical outcome
Effectiveness outcomes may include differences between PACT and controls in terms of HbA1c DM-related complications DM-related deaths or quality-adjusted life years QALYs
This is a cluster randomised controlled trial comparing the PACT program to Usual Care Each cluster consists of a Teamlet in a NHG Polyclinic consisting of a regular group of Family Physicians a Care Manager and a Care Coordinator that provide chronic care for a regular group of about 5000 patients
Study Population
The study population will include patients with suboptimal control of diabetes HbA1c 8 between the ages of 21 to 64 Patients with a suboptimal control of diabetes frequently require a combination of both pharmacological and lifestyle measures for improvement of their glycaemic levels
The inclusion criteria include the following
Individuals with a diagnosis of Type 2 Diabetes Mellitus who are enrolled in Teamlets in NHGP
Age between 21 to 64 years old
HbA1c level of more than 8 in the last 6 months
The exclusion criteria includes the following
History of acute coronary syndrome in the past 3 months
History of stroke or transient ischaemic attacks in the past 3 months
History of end stage organ failure liver cirrhosis cardiac failure latest eGFR 30 mLmin173m2 in the last 6 months
Cancer requiring treatment in the past 5 years
Active psychiatrist follow up
Social issues that are significant enough for follow-up or referral with a medical social worker within the last 12 months
Women who are pregnant or breastfeeding
Patients who are enrolled in other current diabetes-related interventional studies
Inability to provide written consent for the study protocol and able to commit to the study duration
These patients are excluded as they may have conditions that could be of a higher priority for management as compared to Diabetes Mellitus and may not be able to provide informed consent or participate actively in shared decision making
Summary of Study Design
The unit of randomisation will be each cluster as represented by a single Teamlet Randomisation will be carried out on all Teamlets that are involved in this research study from NHG Polyclinics The study team aims to involve two to three polyclinics that includes six Teamlets in each polyclinic A total of 12 to 18 Teamlets will hence be involved subject to resource and recruitment considerations
Teamlets in each polyclinic will be randomised to either the PACT Program condition or Usual Care condition Patients who belong to Teamlets that are randomised to the PACT Program condition will be recruited for participation in the PACT Program and patients who belong to Teamlets that are randomised to the Usual Care condition will be recruited and provided with routine care Due to the nature of the PACT intervention blinding of the Teamlet members Doctor Care Manager Care Coach and patients will not be feasible The data analyst will be blinded to the group allocation
The PACT Program intervention will last 3 months Four participant assessments will be conducted and this will take place at baseline and at the 3-month 6-month and the 12-month mark
Recruitment of participants will take place over 12 months and follow-up of participants will be carried out over 24 months Further analysis will be undertaken for 12 months so the total length of the study will be 4 years and 0 months
PACT program procedures The PACT program lasts 3 months and is a health coaching program for people with type 2 diabetes
Patients have an in-person visit with a Care Coach at the baseline visit where review of their metabolic parameters self-care behaviors and health motivators is carried out supported by use of a PACT form This is followed by goal setting
The PACT form consists of
1 Results of patients latest clinical readings are shared with the patient
2 Patient fills in their key motivators for managing their diabetes well
3 Patient fills in a survey that assesses their own self-care behaviors diet exercise medication adherence diabetes distress
4 Goal setting with the care coach to set SMART specific measurable achievable relevant and time-sensitive goals
The Care Coach has been trained to apply a bio-psychosocial approach motivational interviewing skills and provide diabetes care support The discussion will take approximately 15 to 30 minutes
Supportive follow-up is provided over the following 3 months The Care Coach will support patients in reviewing their goals assist in problem solving and provide motivational support Follow-up will be conducted 2 weekly via telephone calls andor WhatsApp messages according to the patients preference Care coaches will minimally send patients a whatsapp message or conduct a phone call however we acknowledge that some patients may not reply or pick up the phone This will take approximately 10 to 20 minutes each time After 3 months the patients will be reverted back to routine clinical care
Outcome Assessments
Patient outcomes will be assessed at baseline 12 months before study period and at regular intervals over 24 months for clinical data Patient reported outcomes will be assessed at 3 6 and 12 months
1 Clinical Outcomes
Clinical outcomes will be extracted from the NHGP Business Intelligence database from routinely collected data
The outcomes that will be assessed include
Clinical outcomes at baseline and follow-up HbA1c systolic and diastolic blood pressure body mass index Total cholesterol HDL-cholesterol LDL-cholesterol and Triglyceride levels serum creatinine level estimated glomerular filtration rate urine albumin-creatinine ratio and the urine protein-creatinine ratio
At baseline Presence of co-morbidities which include hypertension hyperlipidaemia ischaemic heart disease stroke peripheral vascular disease previous lower limb amputations chronic kidney disease diabetic neuropathy and diabetic retinopathy
Patients usually make clinic visits every 3 to 6 months Clinical outcomes data will be obtained for baseline and over a period of 24 months
2 Patient reported outcomes
Patient reported outcomes will be assessed using a questionnaire at baseline at the 3-month mark 6-month mark and at the 12-month mark
The questionnaire will be self-administered with interviewer assistance on patient request
The baseline and follow-up questionnaires include the following measures
Sociodemographic information - Only in baseline questionnaire
Self-care behaviours measured with the Summary of Diabetes Self-Care Activities scale SDSCA
Diabetes-related distress measured with the 2-item Diabetes Distress Scale DDS-2
Diabetes empowerment measured with the short form of the Diabetes Empowerment Scale DES-SF
Health-related quality of life measured with the EQ-5D-5L
Patient satisfaction as measured by 5 questions from the Patient Satisfaction Questionnaire-III- Only in the PACT 3-month questionnaire
3 Referral to community exercise programs As part of comprehensive lifestyle management the patients may be directed to community exercise programs such as those run by SportSG Attendance to such programs will be recorded via patient-reported information in the 3-month 6-month and 12-month questionnaires
4 Adverse events Improvements in self-care behaviors diet and physical activity may be associated with hypoglycaemic symptoms Monitoring for serious hypoglycaemic episodes requiring emergency department visit andor admissions to hospital will be recorded via patient-reported information the 3-month 6-month and 12-month questionnaires
5 Drugs Prescribed Drugs could affect clinical outcomes such as HbA1c Information such as drug prescribed dosage and cost of medications will be extracted from NHGP Business Intelligence database
6 Resources and Cost
Costs and resource utilisation will be analysed including
Health-service utilisation costs including Medical Doctor Nursing Care Manager Allied Health Dietician Psychologist Medical Social Worker consultation sessions
Training and utilisation costs for the Care Coaches including the number of TelephoneWhatsApp follow-up calls by the Care Coaches
Laboratory tests
Medication costs
Sample Size and Statistical Methods
Estimation of Sample Size A minimal clinically important difference of 04 in HbA1c is expected between participants of the PACT program compared with Usual Care In estimating the sample size a standard deviation of 12 was used as estimated from a local study We aim to recruit between 12 to 18 Teamlets in the study If 12 Teamlets are recruited 6 Teamlets are randomised to PACT and 6 to the control group 34 subjects are required for each Teamlet total 204 participants in the PACT program and 204 participants in Usual Care at 80 power with one-sided alpha at 5 and setting the intracluster correlation coefficient at 001 with an assumed drop-out rate of 20 If 18 Teamlets are recruited 9 randomised to PACT and 9 to the control group 24 subjects are required for each Teamlet 216 participants in the PACT program and 216 participants in Usual Care at 80 power with one-sided alpha at 5 and setting the intracluster correlation coefficient at 001 with an assumed drop-out rate of 20 Sample size calculations were conducted using SampSizeV2
Statistical and Analytical Plans
1 Clinical Outcomes evaluation Categorical data will be summarized as counts percentage while continuous data will be summarized as mean standard deviation if they are normally distributed or median interquartile range if they are skewed Baseline characteristics will be compared between participants in the PACT program and Usual care Differences in the outcomes of interest clinical and patient-reported at different data points will be compared between participants in the PACT program and Usual Care As this is a cluster-randomised trial a mixed model will be used to evaluate the longitudinal difference-in-difference outcomes between the PACT program and Usual Care incorporating Teamlets as the random effect Relevant baseline covariates will be included in the model to account for potential confounding factors
2 Resource and cost evaluation This study will analyse the cost-effectiveness and resource utilisation of the PACT program The potential economic impact of new program implementation will be studied by estimating the incremental cost effectiveness ratio ICER between PACT and Usual Care incremental direct medical cost per unit improvement in clinical outcome
Effectiveness outcomes may include differences between PACT and controls in terms of HbA1c DM-related complications DM-related deaths or quality-adjusted life years QALYs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None