Computerized Cognitive Training to Protect Cognitive Function Among Hypertension Patients

Back to results

Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Multi-domain adaptive cognitive training

Basic cognitive training with no difficulty change

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Cognitive training, Digital health, Hypertension

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Older than 60 years; Completed 6 or more years of education; Untreated or under treatment hypertension; Complaint of memory decline within 1 year; Global cognitive score measured by the Montreal Cognitive Assessment is below 26; Agree to receive cognitive function evaluation, randomization, and follow-up investigation as required; Exclusion Criteria: Unable to complete cognitive function evaluation due to vision, hearing, and other problems; Have been diagnosed of dementia or MMSE score ≤ 20; Unable to use the cognitive training equipment after 2 times instructions; Alcohol abuse or taking drugs that could affect cognitive function (antihistamines, antipsychotics); Diabetes patients; Moderate to severe decrease in glomerular filtration rate (eGFR<30 ml/min /1.73m2); Systolic blood pressure ≥180 mmHg or/and diastolic blood pressure ≥110 mmHg; or orthostatic hypotension (defined as the third standing SBP<100mmHg); History of cardiovascular events or hospitalization due to cardiovascular diseases in the last 3 months; Planned to receive coronary intervention, atrial fibrillation ablation or cardiac surgery within 6 months; or have received these intervention strategies in the last 3 months; Symptomatic heart failure or left ventricular ejection fraction <50%； Atrial fibrillation confirmed by ECG with marked and severe onset of symptoms; A history of stroke, or head injury in the last 6 months; past history of brain tumor or neurosurgery; Past history of Parkinson's disease, Alzheimer's disease, schizophrenia, and epilepsy; Have Ever undergone surgery under general anesthesia in the last three months; Severe hepatic impairment or in critical condition patients with very poor prognosis whose expected survival is less than 6 months; or diagnosed of malignant tumor other than non-melanoma skin cancer in the last 2 years; Contradictions for MRI examination: such as metal implantation, claustrophobia, etc.; Unable to obtain an informed consent or currently taking part in other clinical trials

Sites / Locations

Beijing Anzhen Hospital
Ruijing Hospital, Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adaptive cognitive training

Active control

Arm Description

This arm is the intervention arm. Participants randomized to this arm will use a tablet to receive the multi-domain adaptive cognitive training, which will be delivered 30 minutes at least 5 times a week for 12 weeks.

This arm is the control arm. Participants randomized to this arm will use the same tablet to receive the cognitive training of low difficulty level with no adaptive change. The intervention dosage will be the same, which is 30 minutes each time, at least 5 times a week for 12 weeks.

Outcomes

Primary Outcome Measures

Global cognitive function change measured by BCAT in 12 weeks

The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function measured by Basic Cognitive Ability Test (BCAT). BCAT is a set of neuropsychological battery tests which was designed to measure global cognitive fucntion and cognitive function of sub-domains. Higher scores of BCAT means a better global cognitive function.

Secondary Outcome Measures

Global cognitive function change measured by BCAT in 24 weeks

The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function at 24 weeks measured by Basic Cognitive Ability Test(BCAT).

Sub-domain cognitive function improvement including memory, attention, and execution memory

The proportion of patients whose sub-domain cognitive function, including attention, memory, execution function improves measured by the individual capability test in BCAT.

Cognitive score change

Mean change from baseline in global cognitive function score measured by basic cognitive ability test (BCAT) at 12 weeks and 24 weeks.

Self-efficacy score

Mean change from baseline in self-efficacy score measured by the General Self-Efficacy Scale at 12 weeks, and 24 weeks

Quality of life score

Mean change from baseline in the patient's quality of life score measured by EQ-5D-3L at 12 weeks and 24 weeks.

Anxiety score

Mean change from baseline in the patient's anxiety score at 12 weeks and 24 weeks. Anxiety status will be measured by GAD-7 questionnaire. Higher score of GAD-7 scale represents more anxiety status.

Depression score

Mean change from baseline in the patient's depression score at 12 weeks and 24 weeks. Depression status will be measured by PHQ-9 questionnaire. Higher score of PHQ-9 scale represents more depression status.

Full Information

NCT ID

NCT05704270

First Posted

January 9, 2023

Last Updated

January 20, 2023

Sponsor

Beijing Anzhen Hospital

Collaborators

Beijing Wispirit Technology Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05704270

Brief Title

Computerized Cognitive Training to Protect Cognitive Function Among Hypertension Patients

Official Title

The Efficacy of Computerized Cognitive Training in Patients With Hypertension and Cognitive Impairment, no Dementia: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 1, 2023 (Anticipated)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Anzhen Hospital

Collaborators

Beijing Wispirit Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Hypertension is an risk factor for cognitive impairment. The primary objective of this study is to evaluate the efficacy of 12-week computerized cognitive training in people with hypertension and mild cognitive impairment. The researchers will further investigate the long-term effects of cognitive training by prolonging the intervention for 24 weeks among a randomly selected sub-group.

Detailed Description

This study is a double-blinded, randomized controlled trial. A total of 200 hypertension patients with mild cognitive impairment will be recruited to participate in this study after screening. These patients will be randomized to two arms under masking. The intervention arm will receive multi-domain adaptive cognitive training using a tablet. The control arm will receive an active control treatment and use the same tablet to receive the cognitive training tasks with weak difficulty change. Both arms will receive the same intervention dosage for 12 weeks, 5 times a week, and 30 minutes per time. After the 12-week intervention, the intervention arm will be re-randomized into two groups. One group will stop their intervention at 12 weeks; the other group will continue to receive the multi-domain adaptive cognitive training till the 24-week follow-up assessment. The neuro-psychological assessment will be administered at baseline, 12-week, and 24-week assessments for all participants. The structural and functional MRI will be administered at baseline, 12 weeks, and 24 weeks to evaluate the effect of cognitive training on brain structure and function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment, Hypertension

Keywords

Cognitive training, Digital health, Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adaptive cognitive training

Arm Type

Experimental

Arm Description

This arm is the intervention arm. Participants randomized to this arm will use a tablet to receive the multi-domain adaptive cognitive training, which will be delivered 30 minutes at least 5 times a week for 12 weeks.

Arm Title

Active control

Arm Type

Active Comparator

Arm Description

This arm is the control arm. Participants randomized to this arm will use the same tablet to receive the cognitive training of low difficulty level with no adaptive change. The intervention dosage will be the same, which is 30 minutes each time, at least 5 times a week for 12 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Multi-domain adaptive cognitive training

Intervention Description

The multi-domain adaptive cognitive training covers seven aspects of fundamental cognitive function, including sensory perception, cognitive flexibility, attention, memory, language, logic calculation, and emotion recognition and management. A self-adaptive algorithm is embedded in the tablet-based cognitive training platform, which will help deliver suitable tasks at the right difficulty level for each participant according to their personal profile and real-time performance. The intervention dosage is 30 minutes per time, 5 times a week.

Intervention Type

Behavioral

Intervention Name(s)

Basic cognitive training with no difficulty change

Intervention Description

The basic cognitive training for the control arm will also be delivered via a tablet. The training tasks will be fixed at a primary difficulty level without adaptive algorithm. The intervention dosage is also 30 minutes per time, 5 times a week.

Primary Outcome Measure Information:

Title

Global cognitive function change measured by BCAT in 12 weeks

Description

The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function measured by Basic Cognitive Ability Test (BCAT). BCAT is a set of neuropsychological battery tests which was designed to measure global cognitive fucntion and cognitive function of sub-domains. Higher scores of BCAT means a better global cognitive function.

Time Frame

12 weeks after randomization

Secondary Outcome Measure Information:

Title

Global cognitive function change measured by BCAT in 24 weeks

Description

The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function at 24 weeks measured by Basic Cognitive Ability Test(BCAT).

Time Frame

24 weeks after randomization

Title

Sub-domain cognitive function improvement including memory, attention, and execution memory

Description

The proportion of patients whose sub-domain cognitive function, including attention, memory, execution function improves measured by the individual capability test in BCAT.

Time Frame